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IRVINE, CA, and HERSTAL, BELGIUM - 07:00 CEST, May 5, 2017 - MDxHealth SA (Euronext: MDXH.BR), today announced that it has signed an agreement with the Faculty of Health, Medicine and Life Sciences / School for Oncology and Developmental Biology (GROW) at Maastricht University to expand its existing research collaboration to develop commercial next generation (epi)genetic cancer diagnostics. Under the terms of the multi-year R&D agreement, the collaboration will focus on developing (epi)genetic-based assays to provide better insight in the diagnosis, staging and treatment of cancer patients. For these next generation assays, the focus will be on sample in and result out based platforms. This technology would also be applied to MDxHealth's current and upcoming liquid biopsy tests including SelectMDx(TM) for Prostate Cancer. "GROW at Maastricht University are true visionaries and we are fortunate to have such a long-standing and collaborative relationship," said Dr. Jan Groen, CEO of MDxHealth. "The development of next generation liquid biopsy diagnostics for oncology will be game-changing and help physicians manage their patients faster and more effectively." "As a thought-leader in epigenetics, MDxHealth is the ideal partner to collaborate on next generation (epi)genetic diagnostics," said Prof. Dr. Manon van Engeland, Professor of Pathobiology of Cancer and Scientific Vice-Director of GROW. "MDxHealth's expanding portfolio of liquid biopsy tests are ideal to run on the assays we're in the process of developing." "We are delighted that MDxHealth is joining our science business community at the Brightlands Maastricht Health Campus," said Jan Cobbenhagen, CEO of the Brightlands Maastricht Health Campus. "MDxHealth fits perfectly in our thriving ecosystem of startups, SMEs, multinationals and renowned knowledge institutions.'' GROW is the School for Oncology and Developmental Biology at the Maastricht University Medical Centre (MUMC+), The Netherlands, and accredited by the Royal Academy of Arts and Sciences (KNAW). GROW focuses on research and teaching of (epi)genetic and cellular concepts, as well as (micro)environmental factors underlying normal and abnormal development. With a strong emphasis on translational research, scientists and clinicians within GROW aim at implementing basic knowledge into innovative approaches for individualizing prevention, patient diagnostics and treatment of cancer. More information about GROW is available at http://www.grow-um.nl. MDxHealth is a multinational healthcare company that provides actionable molecular diagnostic information to personalize the diagnosis and treatment of cancer. The company's tests are based on proprietary genetic, epigenetic (methylation) and other molecular technologies and assist physicians with the diagnosis of urologic cancers, prognosis of recurrence risk, and prediction of response to a specific therapy. The Company's European headquarters are in Herstal, Belgium, with laboratory operations in Nijmegen, The Netherlands, and US headquarters and laboratory operations based in Irvine, California. For more information, visit mdxhealth.com and follow us on Twitter at: twitter.com/mdxhealth. Brightlands Maastricht Health Campus brings together brilliant scientists and opportunity-driven entrepreneurs to create one of Europe's most prominent ecosystems for Life Science and Health. The campus is home to scientific and clinical institutions like the Maastricht University Medical Center, the Faculty of Health, Medicine and Life Sciences of Maastricht University, and the Maastro Clinic for Radiation Therapy. Furthermore, it harbors over 70 start-up companies and SMEs, as well as renowned multinationals like Bayer Healthcare, Boston Scientific, and Medtronic. Focus areas include, amongst others, Regenerative Medicine, Precision Medicine, and Innovative Diagnostics. For more information, visit https://www.brightlands.com. This press release contains forward-looking statements and estimates with respect to the anticipated future performance of MDxHealth and the market in which it operates. Such statements and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct. Actual events are difficult to predict, may depend upon factors that are beyond the company's control, and may turn out to be materially different. MDxHealth expressly disclaims any obligation to update any such forward-looking statements in this release to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based unless required by law or regulation. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of MDxHealth in any jurisdiction. No securities of MDxHealth may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. securities laws. NOTE: The MDxHealth logo, MDxHealth, ConfirmMDx, SelectMDx, AssureMDx and PredictMDx are trademarks or registered trademarks of MDxHealth SA. All other trademarks and service marks are the property of their respective owners.


Sassen S.,Atrium Medical | De Booij M.,Atrium Medical | Sosef M.,Atrium Medical | Berendsen R.,Atrium Medical | And 6 more authors.
European Radiology | Year: 2013

Objectives: To determine retrospectively the additional value of DWI-MRI toT2-MRI for predicting complete response (ypT0N0 = CR) after chemoradiation-therapy (CRT) in locally advanced rectal cancer. Methods: Seventy locally advanced rectal cancer patients underwent CRT followed by restaging MRI and resection. Two readers with different experience levels independently scored T2 images for CR and, in a second reading, combined T2 and DWI. A 5-point confidence-level score was used to generate ROC curves. Areas under the ROC curves (AUC) and interobserver agreement were compared for both readings. Histology served as reference standard. Results: The interobserver agreement increased after addition of DWI from 0.35 to 0.58 but the AUC improved only for the experienced reader (0.77 to 0.89, p = 0.005 vs. 0.74 to 0.70, p > 0.05). Sensitivity and NPV improved from 20-30 % to 40-70 %, respectively 88 % to 91-95 %. Specificity and PPV improved only for the experienced reader (87 to 93 % respectively 27 to 63 %). Conclusion: Adding DWI to T2-MRI improves consistency between readers and has potential to improve readers' accuracy dependent on his/her experience. DWI could be of additional value, particularly in ruling out CR (high NPV), but considering the sub-optimal PPV one should be cautious about relying solely on MRI for the clinical decision to offer a wait-and-see strategy. Key Points: • Diffusion-weighted magnetic resonance imaging is increasingly used to assess rectal tumours • Adding DWI to T2-MRI potentially improves diagnostic accuracy for identifying complete responders • Adding DWI to T2-MRI improves consistency among readers with different experience levels. • This combination can help rule out complete tumour response. • Patients should not be selected for wait-and-see strategies by MRI alone. © 2013 European Society of Radiology.


Creutzberg C.L.,Leiden University | Nout R.A.,Leiden University | Lybeert M.L.M.,Catharina Hospital Eindhoven | Warlam-Rodenhuis C.C.,University Utrecht | And 6 more authors.
International Journal of Radiation Oncology Biology Physics | Year: 2011

Purpose: To evaluate the very long-term results of the randomized Post Operative Radiation Therapy in Endometrial Carcinoma (PORTEC)-1 trial for patients with Stage I endometrial carcinoma (EC), focusing on the role of prognostic factors for treatment selection and the long-term risk of second cancers. Patients and Methods: The PORTEC trial (1990-1997) included 714 patients with Stage IC Grade 1-2 or Stage IB Grade 2-3 EC. After surgery, patients were randomly allocated to external-beam pelvic radiotherapy (EBRT) or no additional treatment (NAT). Analysis was by intention to treat. Results: 426 patients were alive at the date of analysis. The median follow-up time was 13.3 years. The 15-year actuarial locoregional recurrence (LRR) rates were 6% for EBRT vs. 15.5% for NAT (p < 0.0001). The 15-year overall survival was 52% vs. 60% (p = 0.14), and the failure-free survival was 50% vs. 54% (p = 0.94). For patients with high-intermediate risk criteria, the 15-year overall survival was 41% vs. 48% (p = 0.51), and the 15-year EC-related death was 14% vs. 13%. Most LRR in the NAT group were vaginal recurrences (11.0% of 15.5%). The 15-year rates of distant metastases were 9% vs. 7% (p = 0.25). Second primary cancers had been diagnosed over 15 years in 19% of all patients, 22% vs. 16% for EBRT vs. NAT (p = 0.10), with observed vs. expected ratios of 1.6 (EBRT) and 1.2 (NAT) compared with a matched population (p = NS). Multivariate analysis confirmed the prognostic significance of Grade 3 for LRR (hazard ratio [HR] 3.4, p = 0.0003) and for EC death (HR 7.3, p < 0.0001), of age >60 (HR 3.9, p = 0.002 for LRR and 2.7, p = 0.01 for EC death) and myometrial invasion >50% (HR 1.9, p = 0.03 and HR 1.9, p = 0.02). Conclusions: The 15-year outcomes of PORTEC-1 confirm the relevance of HIR criteria for treatment selection, and a trend for long-term risk of second cancers. EBRT should be avoided in patients with low- and intermediate-risk EC. © 2011 Elsevier Inc.


Kimman M.L.,MAASTRO Clinic | Kimman M.L.,Maastricht University | Bloebaum M.M.F.,MAASTRO Clinic | Dirksen C.D.,Maastricht University | And 5 more authors.
BMC Cancer | Year: 2010

Background: Current frequent follow-up after treatment for breast cancer does not meet its intended aims, but does depend on expensive and scarce specialized knowledge for routine history taking and physical examinations. The study described in this paper compared patient satisfaction with a reduced follow-up strategy, i.e. nurse-led telephone follow-up, to satisfaction with traditional hospital follow-up.Methods: Patient satisfaction was assessed among patients (n = 299) who were participants of a randomized controlled trial investigating the cost-effectiveness of several follow-up strategies in the first year after treatment for breast cancer. Data on patient satisfaction were collected at baseline, three, six and 12 months after treatment, using the Dutch version of Ware's Patient Satisfaction Questionnaire III (PSQ III). In addition to general satisfaction, the PSQ III reports on satisfaction scores for technical competence, interpersonal aspects, and access of care. Regression analysis was used to predict satisfaction scores from whether or not nurse-led telephone follow-up was received.Results: Nurse-led telephone follow-up had no statistically significant influence on general patient satisfaction (p = 0.379), satisfaction with technical competence (p = 0.249), and satisfaction with interpersonal aspects (p = 0.662). Regarding access of care, patient satisfaction scores were significantly higher for patients receiving telephone follow-up (p = 0.015). However, a mean difference at 12 months of 3.1 points was judged to be not clinically relevant.Conclusions: No meaningful differences were found in satisfaction scores between nurse-led telephone and hospital follow-up in the first year after breast cancer treatment. With high satisfaction scores and the potential to substantially reduce clinic visits, nurse-led telephone follow-up may be an acceptable alternative to traditional hospital follow-up.Trial registration number: ISRCTN 74071417. © 2010 Kimman et al; licensee BioMed Central Ltd.


Curvo-Semedo L.,University of Coimbra | Lambregts D.M.J.,Maastricht University | Maas M.,Maastricht University | Thywissen T.,Maastricht University | And 5 more authors.
Radiology | Year: 2011

Purpose: To determine diagnostic performance of diffusion-weighted (DW) magnetic resonance (MR) imaging for assessment of complete tumor response (CR) after combined radiation therapy with chemotherapy (CRT) in patients with locally advanced rectal cancer (LARC) by means of volumetric signal intensity measurements and apparent diffusion coefficient (ADC) measurements and to compare the performance of DW imaging with that of T2-weighted MR volumetry. Materials and Methods: A retrospective analysis of 50 patients with LARC, for whom clinical and imaging data were retrieved from a previous imaging study approved by the local institutional ethical committee and for which all patients provided informed consent, was conducted. Patients underwent pre- and post-CRT standard T2-weighted MR and DW MR. Two independent readers placed free-hand regions of interest (ROIs) in each tumor-containing section on both data sets to determine pre- and post-CRT tumor volumes and tumor volume reduction rates (Δvolume). ROIs were copied to an ADC map to calculate tumor ADCs. Histopathologic findings were the standard of reference. Receiver operating characteristic (ROC) curves were generated to compare performance of T2-weighted and DW MR volumetry and ADC. The intraclass correlation coefficient (ICC) was used to evaluate interobserver variability and the correlation between T2-weighted and DW MR volumetry. Results: Areas under the ROC curve (AUCs) for identification of a CR that was based on pre-CRT volume, post-CRT volume, and Δvolume, respectively, were 0.57, 0.70, and 0.84 for T2-weighted MR versus 0.63, 0.93, and 0.92 for DW MR volumetry (P =.15,.02,.42). Pre- and post-CRT ADC and ΔADC AUCs were 0.55, 0.54, and 0.51, respectively. Interobserver agreement was excellent for all pre-CRT measurements (ICC, 0.91-0.96) versus good (ICC, 0.61-0.79) for post-CRT measurements. ICC between T2-weighted and DW MR volumetry was excellent (0.97) for pre-CRT measurements versus fair (0.25) for post-CRT measurements. Conclusion: Post-CRT DW MR volumetry provided high diagnostic performance in assessing CR and was significantly more accurate than T2-weighted MR volumetry. Post-CRT DW MR was equally as accurate as Δvolume measurements of both T2-weighted and DW MR. Pre-CRT volumetry and ADC were not reliable. © RSNA, 2011.


Bartelink H.,Netherlands Cancer Institute | Maingon P.,Center Georges Francois Leclerc | Poortmans P.,Institute Verbeeten | Poortmans P.,Radboud University Nijmegen | And 19 more authors.
The Lancet Oncology | Year: 2015

Background: Since the introduction of breast-conserving treatment, various radiation doses after lumpectomy have been used. In a phase 3 randomised controlled trial, we investigated the effect of a radiation boost of 16 Gy on overall survival, local control, and fibrosis for patients with stage I and II breast cancer who underwent breast-conserving treatment compared with patients who received no boost. Here, we present the 20-year follow-up results. Methods: Patients with microscopically complete excision for invasive disease followed by whole-breast irradiation of 50 Gy in 5 weeks were centrally randomised (1:1) with a minimisation algorithm to receive 16 Gy boost or no boost, with minimisation for age, menopausal status, presence of extensive ductal carcinoma in situ, clinical tumour size, nodal status, and institution. Neither patients nor investigators were masked to treatment allocation. The primary endpoint was overall survival in the intention-to-treat population. The trial is registered with ClinicalTrials.gov, number NCT02295033. Findings: Between May 24, 1989, and June 25, 1996, 2657 patients were randomly assigned to receive no radiation boost and 2661 patients randomly assigned to receive a radiation boost. Median follow-up was 17·2 years (IQR 13·0-19·0). 20-year overall survival was 59·7% (99% CI 56·3-63·0) in the boost group versus 61·1% (57·6-64·3) in the no boost group, hazard ratio (HR) 1·05 (99% CI 0·92-1·19, p=0·323). Ipsilateral breast tumour recurrence was the first treatment failure for 354 patients (13%) in the no boost group versus 237 patients (9%) in the boost group, HR 0·65 (99% CI 0·52-0·81, p<0·0001). The 20-year cumulative incidence of ipsilatelal breast tumour recurrence was 16·4% (99% CI 14·1-18·8) in the no boost group versus 12·0% (9·8-14·4) in the boost group. Mastectomies as first salvage treatment for ipsilateral breast tumour recurrence occurred in 279 (79%) of 354 patients in the no boost group versus 178 (75%) of 237 in the boost group. The cumulative incidence of severe fibrosis at 20 years was 1·8% (99% CI 1·1-2·5) in the no boost group versus 5·2% (99% CI 3·9-6·4) in the boost group (p<0·0001). Interpretation: A radiation boost after whole-breast irradiation has no effect on long-term overall survival, but can improve local control, with the largest absolute benefit in young patients, although it increases the risk of moderate to severe fibrosis. The extra radiation dose can be avoided in most patients older than age 60 years. © 2015 Elsevier Ltd.


Lambregts D.M.J.,Maastricht University | Maas M.,Maastricht University | Bakers F.C.H.,Maastricht University | Cappendijk V.C.,Maastricht University | And 3 more authors.
Diseases of the Colon and Rectum | Year: 2011

BACKGROUND: The "wait-and-see" policy instead of standard surgery for patients with rectal cancer who undergo a complete tumor regression after chemoradiation treatment is highly controversial. It is not clear yet how patients should be monitored once they are managed nonoperatively and whether follow-up by MRI has any potential role. OBJECTIVE: This study aimed to describe the rectal wall MRI morphology during short-term and long-term followup in patients with a clinical complete tumor response undergoing a wait-and-see policy without surgical treatment. DESIGN, SETTING, AND PATIENTS: As part of an observational study in our center, a cohort of 19 carefully selected patients with a clinical complete response after chemoradiation was managed with a wait-and-see policy and followed regularly (every 3-6 mo) by clinical examination, endoscopy with biopsies, and a rectal MRI. The MR morphology of the tumor bed was studied on the consecutive MRI examinations. MAIN OUTCOME MEASURES: The primary outcome measured was the morphology of the tumor bed on the consecutive MRI examinations performed during shortterm (≤6 mo) and long-term (>6 mo) follow-up. RESULTS: Patients with a complete tumor response after chemoradiation presented with either a normalized rectal wall (26%) or fibrosis (74%). In the latter group, 3 patterns of fibrosis were observed (full-thickness, minimal, or spicular fibrosis). The morphology patterns of a normalized rectal wall or fibrosis remained consistent during long-term follow-up in 18 of 19 patients. One patient developed a small, endoluminal recurrence, which was salvaged with transanal endoscopic microsurgery. In 26% of patients, an edematous wall thickening was observed in the first months after chemoradiation, which gradually decreased during long-term follow-up. Median follow-up was 22 months (range, 12-60). LIMITATIONS: This was a small observational study, and had no histological validation. CONCLUSIONS: Four MR patterns of a persistent complete response of rectal cancer after chemoradiation were identified. These MR features can serve as a reference for the follow-up in a wait-and-see policy. ©The ASCRS 2011.


Braam P.,Radboud University Nijmegen | Lambin P.,MAASTRO Clinic | Bussink J.,Radboud University Nijmegen
Trials | Year: 2016

Background: Painful spinal metastases have been treated with conventional radiotherapy for decades, but one-third of the patients have insufficient pain relief after treatment and one-fifth need retreatment. Stereotactic radiotherapy is a method to increase the dose in the spinal metastases with a potentially longer lasting palliative effect without increasing the side effects of the treatment and thereby is expected to improve the quality of life significantly. Methods/Design: This study is a multicenter prospective randomized clinical trial comparing conventional radiotherapy (1 x 8Gy) with stereotactic radiotherapy (1 x 20Gy) for pain reduction and quality of life in patients with painful spinal metastases. A total of 386 patients will be randomized between the two treatment groups. Besides pain measured by the Dutch Brief Pain Inventory, quality of life and cost-effectiveness also will be measured. The primary outcome is pain reduction at 6 weeks after treatment. Secondary outcomes will be the time to pain response, duration of pain relief, health-related quality of life and toxicity, as well as cost-effectiveness. Discussion: This study investigates whether stereotactic radiotherapy with dose escalation for symptomatic spinal metastases can lead to improved pain reduction as compared to conventional radiotherapy without an increase of treatment-related side effects. These results will contribute to the optimization and individualization of the treatment for the patient. Trial registration: ClinicalTrials.gov identifier NCT02407795(March 31, 2015). © 2016 Braam et al.


Peulen H.,MAASTRO Clinic | Hanbeukers B.,MAASTRO Clinic | Boersma L.,MAASTRO Clinic | Van Baardwijk A.,MAASTRO Clinic | And 5 more authors.
International Journal of Radiation Oncology Biology Physics | Year: 2012

Purpose: To explore forward planning methods for breast cancer treatment to obtain homogeneous dose distributions (using International Commission on Radiation Units and Measurements criteria) within normal tissue constraints and to determine the feasibility of class solutions. Methods and Materials: Treatment plans were optimized in a stepwise procedure for 60 patients referred for postlumpectomy irradiation using strict dose constraints: planning target volume (PTV) 95% of >99%; V 107% of <1.8 cc; heart V 5 Gy of <10% and V 10 Gy of <5%; and mean lung dose of <7 Gy. Treatment planning started with classic tangential beams. Optimization was done by adding a maximum of four segments before adding beams, in a second step. A breath-hold technique was used for heart sparing if necessary. Results: Dose constraints were met for all 60 patients. The classic tangential beam setup was not sufficient for any of the patients; in one-third of patients, additional segments were required (<3), and in two-thirds of patients, additional beams (<2) were required. Logistic regression analyses revealed central breast diameter (CD) and central lung distance as independent predictors for transition from additional segments to additional beams, with a CD cut-off point at 23.6 cm. Conclusions: Treatment plans fulfilling strict dose homogeneity criteria and normal tissue constraints could be obtained for all patients by stepwise dose intensity modification using limited numbers of segments and additional beams. In patients with a CD of >23.6 cm, additional beams were always required. Copyright © 2012 Elsevier Inc. Printed in the USA. All rights reserved.


Siedschlag C.,Netherlands Cancer Institute | Boersma L.,MAASTRO Clinic | Van Loon J.,MAASTRO Clinic | Rossi M.,Netherlands Cancer Institute | And 3 more authors.
Radiotherapy and Oncology | Year: 2011

Purpose: To indicate which clinical target volume (CTV) margin (if any) is needed for an adequate treatment of non-small-cell lung cancer (NSCLC) using either 3D conformal or stereotactic radiotherapy, taking the distribution of the microscopic disease extension (MDE) into account. Methods and materials: On the basis of the linear-quadratic biological model, a Monte-Carlo simulation was used to study the impact of MDE and setup deviations on the tumor control probability (TCP) after typical 3D conformal and stereotactic irradiation techniques. Setup deviations were properly accounted for in the planning target volume (PTV) margin. Previously measured distributions of MDE outside the macroscopic tumor in NSCLC patients were used. The dependence of the TCP on the CTV margins was quantified. Results: The presence of MDE had a demonstratable influence on the TCP in both the 3D conformal and the stereotactic technique when no CTV margins were employed. The impact of MDE on the TCP values was greater in the 3D conformal scenario (67% TCP with MDE; 84% TCP without MDE) than for stereotactic radiotherapy (91% TCP with MDE; 100% TCP without MDE). Accordingly, an increase of the CTV margin had the greatest impact for the 3D conformal technique. Larger setup errors, with appropriate PTV margins, lead to an increase in TCP for both techniques, showing the interdependence of CTV and PTV margins. Conclusions: MDE may not always be eradicated by the beam penumbra or existing PTV margins using either 3D conformal or stereotactic radiotherapy. Nonetheless, TCP modeling indicates an overall local control rate above 90% for the stereotactic technique, while a non-zero CTV margin is recommended for better local control of MDE when using the 3D conformal technique. © 2011 Elsevier Ireland Ltd. All rights reserved.

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