Whole Body MRI With DWI for Monitoring Patients Treated for Testicular Cancer Stage II-III

NCT03436901 | Completed

• 1 other identifier: VEK RM 1-10-72-179-17
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Testicular Neoplasm

Keywords

magnetic resonance imaging; diffusion weighted imaging

Outcome Measures

Primary Outcomes (1)

• MRI vs CT for testicular cancer

  Non-inferiority design

  Aprox. 1 month after treatment

Secondary Outcomes (1)

• Optimization of MRI scan duration

  Aprox. 1 month after treatment

Study Arms (1)

Testicular cancer st. II-III

OTHER

MRI with DWI vs CT

Diagnostic Test: MRI with DWI vs CT

Interventions

MRI with DWI vs CT DIAGNOSTIC_TEST

MRI with diffusion weighted imaging of thorax, abdomen, and pelvis without contrast agent vs. CT of thorax, abdomen, and pelvis with contrast agent

Testicular cancer st. II-III

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only men have testicular cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed TC stage II-III disease or
• Previously TC stage I disease with new spread of disease during surveillance

You may not qualify if:

• 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

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Aarhus University Hospital, Dept Radiology

Aarhus, 8200, Denmark

Location

Related Publications (10)

• Dansk Testis Cancer Database, Dansk Urologisk Cancer Gruppe: National Årsrapport 2015.

  BACKGROUND

• Danish Urogenital Cancer Group, National guidelines on testicular cancer. 2014

  BACKGROUND

• Albers 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 BACKGROUND

• National 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 BACKGROUND

• Padhani 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 BACKGROUND

• Sivesgaard 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 BACKGROUND

• The Danish Health and Medicines Authority. Pakkeforløb for Testikelkræft.; 2016.

  BACKGROUND

• Krege 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.

  PMID: 18191324 BACKGROUND

• de Wit M, Brenner W, Hartmann M, Kotzerke J, Hellwig D, Lehmann J, Franzius C, Kliesch S, Schlemmer M, Tatsch K, Heicappell R, Geworski L, Amthauer H, Dohmen BM, Schirrmeister H, Cremerius U, Bokemeyer C, Bares R. [18F]-FDG-PET in clinical stage I/II non-seminomatous germ cell tumours: results of the German multicentre trial. Ann Oncol. 2008 Sep;19(9):1619-23. doi: 10.1093/annonc/mdn170. Epub 2008 May 2.

  PMID: 18453520 BACKGROUND

• Larsen SKA, Logager V, Bylov C, Nellemann H, Agerbaek M, Als AB, Pedersen EM. Can whole-body MRI replace CT in management of metastatic testicular cancer? A prospective, non-inferiority study. J Cancer Res Clin Oncol. 2023 Mar;149(3):1221-1230. doi: 10.1007/s00432-022-03996-1. Epub 2022 Apr 7.

  PMID: 35389110 DERIVED

MeSH Terms

Conditions

Testicular Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Erik M Pedersen, MD PhD DMSc

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD student

Model Details: Non-inferiority study

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: February 19, 2018
• Study Start: February 19, 2018
• Primary Completion: July 1, 2021
• Study Completion: October 1, 2021
• Last Updated: January 3, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)