Clinical trial · Interventional
Whole Body MRI With DWI for Monitoring Patients Treated for Testicular Cancer Stage II-III
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Testicular cancer (TC) affects approx. 1% of Danish men and is the most common cancer in men aged 15-35 years. It is the most curable solid cancer type with a 5-year survival rate of 90-95%. Staging and follow-up of these patients involve 5-10 CT scans of each patient, imposing a significant radiation burden: Approx. 3-5 of the 300 Danish patients presenting with TC each year are expected to develop a radiation-induced secondary cancer, half of which are expected to be fatal. MRI is rapidly developing and new WB-MRI can cover large parts of the body in a clinically realistic scan time. With this development, it is within reach to nearly eliminate the radiation burden by substituting the large amount of CT scans with MRI scans in TC. MRI is without any known risk of long-term side effects. Despite this, limited data exist on MRI used in follow-up of TC. At Aarhus University Hospital, we introduced MRI for the follow-up of TC stage I in 2008. We now want to evaluate the results of in this unique cohort of patients and evaluate in a prospective trial if the newest WB-MRI techniques can replace CT in patients with TC stage II-IV. To the best of our knowledge, no study has investigated how much it is possible to reduce the MRI scan time in patients with TC in order to develop a clinically realistic scan time while still maintaining an acceptable uncompromised diagnostic accuracy. The overall aim of this study is to reduce the risk of radiation-induced secondary cancers in patients operated diagnosed with TC by replacing CT as a follow-up imaging method with non-ionizing WB-MRI including DWI. We have these specific aims: * To study the ability of WB-MRI with DWI to replace standard CT in TC stage II-III patients in a prospective non-inferiority study. * To evaluate if it is possible to reduce scan time in the WB-MRI protocols in the TC stage II-III group while maintaining sufficient diagnostic accuracy in order to improve clinical application of the techniques.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Testicular Neoplasm | Testicular Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI with DWI vs CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Testicular cancer st. II-III
- description
- MRI with DWI vs CT
- interventionNames
- Diagnostic Test: MRI with DWI vs CT
Primary outcomes (1)
- measure
- MRI vs CT for testicular cancer
- timeFrame
- Aprox. 1 month after treatment
- description
- Non-inferiority design
Secondary outcomes (1)
- measure
- Optimization of MRI scan duration
- timeFrame
- Aprox. 1 month after treatment
- description
- Can we scan faster without loosing image quality?
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed TC stage II-III disease or * Previously TC stage I disease with new spread of disease during surveillance Exclusion Criteria: * Age \< 18 years * Claustrophobia or unable to fit inside the bore of the MRI-scanner * Foreign metal objects contraindicating a 1.5T MRI including pacemaker
References
Publications (10)
- BACKGROUNDDansk Testis Cancer Database, Dansk Urologisk Cancer Gruppe: National Årsrapport 2015.
- BACKGROUNDDanish Urogenital Cancer Group, National guidelines on testicular cancer. 2014
- BACKGROUNDAlbers P, Albrecht W, Algaba F, Bokemeyer C, Cohn-Cedermark G, Fizazi K, Horwich A, Laguna MP, Nicolai N, Oldenburg J; European Association of Urology. Guidelines on Testicular Cancer: 2015 Update. Eur Urol. 2015 Dec;68(6):1054-68. doi: 10.1016/j.eururo.2015.07.044. Epub 2015 Aug 18. PMID 26297604
- BACKGROUNDNational Research Council (US) Board on Radiation Effects Research. Health Risks from Exposure to Low Levels of Ionizing Radiation: BEIR VII, Phase I, Letter Report (1998). Washington (DC): National Academies Press (US); 1998. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK224187/ PMID 25077203
- BACKGROUNDPadhani AR, Koh DM, Collins DJ. Whole-body diffusion-weighted MR imaging in cancer: current status and research directions. Radiology. 2011 Dec;261(3):700-18. doi: 10.1148/radiol.11110474. PMID 22095994
- BACKGROUNDSivesgaard K, Johnk ML, Larsen LP, Sorensen M, Kramer S, Logager VB, Hansen F, Pedersen EM. Comparison of four MRI protocols for detection of extrahepatic colorectal cancer metastases. J Magn Reson Imaging. 2017 Dec;46(6):1619-1630. doi: 10.1002/jmri.25704. Epub 2017 Mar 16. PMID 28301099
- BACKGROUNDThe Danish Health and Medicines Authority. Pakkeforløb for Testikelkræft.; 2016.
- BACKGROUNDKrege S, Beyer J, Souchon R, Albers P, Albrecht W, Algaba F, Bamberg M, Bodrogi I, Bokemeyer C, Cavallin-Stahl E, Classen J, Clemm C, Cohn-Cedermark G, Culine S, Daugaard G, De Mulder PH, De Santis M, de Wit M, de Wit R, Derigs HG, Dieckmann KP, Dieing A, Droz JP, Fenner M, Fizazi K, Flechon A, Fossa SD, del Muro XG, Gauler T, Geczi L, Gerl A, Germa-Lluch JR, Gillessen S, Hartmann JT, Hartmann M, Heidenreich A, Hoeltl W, Horwich A, Huddart R, Jewett M, Joffe J, Jones WG, Kisbenedek L, Klepp O, Kliesch S, Koehrmann KU, Kollmannsberger C, Kuczyk M, Laguna P, Galvis OL, Loy V, Mason MD, Mead GM, Mueller R, Nichols C, Nicolai N, Oliver T, Ondrus D, Oosterhof GO, Ares LP, Pizzocaro G, Pont J, Pottek T, Powles T, Rick O, Rosti G, Salvioni R, Scheiderbauer J, Schmelz HU, Schmidberger H, Schmoll HJ, Schrader M, Sedlmayer F, Skakkebaek NE, Sohaib A, Tjulandin S, Warde P, Weinknecht S, Weissbach L, Wittekind C, Winter E, Wood L, von der Maase H. European consensus conference on diagnosis and treatment of germ cell cancer: a report of the second meeting of the European Germ Cell Cancer Consensus group (EGCCCG): part I. Eur Urol. 2008 Mar;53(3):478-96. doi: 10.1016/j.eururo.2007.12.024. Epub 2007 Dec 26.