A Study Of 18 FDG PET In The Prediction Of Relapse In Patients With A Clinical Stage I Non-Seminomatous Germ Cell Tumor
- Assess the ability of fludeoxyglucose F 18 positron emission tomography to predict
relapse requiring adjuvant chemotherapy in patients with high-risk stage I
non-seminomatous or mixed seminoma/non-seminomatous germ cell tumor of the testis who
are on current management protocols.
OUTLINE: This is a multicenter study.
Patients receive fludeoxyglucose F 18 (FDG) IV followed 1 hour later by positron emission
tomography (PET) imaging. Patients with metastatic disease identified by FDG PET imaging may
receive adjuvant chemotherapy according to the standard clinical practice at each
participating center. Patients with no metastatic disease identified by FDG PET imaging are
considered for entry into the MRC-TE08 trial (randomized trial of 2 CT scan frequencies in
the surveillance of stage I teratoma) or are followed according to the standard surveillance
Patients with metastatic disease are followed every 6 months. Patients with no metastatic
disease are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1
year, and then every 4-6 months thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: Approximately 135 patients will be accrued for this study within 2-3
Allocation: Non-Randomized, Primary Purpose: Diagnostic
Robert A. Huddart, MD
Royal Marsden NHS Foundation Trust
United States: Federal Government