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Positron Emission Tomography in Detecting Testicle Cancer

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: September 6, 2002
Last updated: December 17, 2013
Last verified: September 2002

RATIONALE: Imaging procedures such as positron emission tomography may improve the ability to detect the extent of cancer and allow doctors to plan more effective treatment for patients who have testicle cancer.

PURPOSE: Diagnostic trial to study the effectiveness of positron emission tomography using fludeoxyglucose F 18 in predicting relapse in patients who have stage I germ cell tumor of the testicle.

Condition Intervention
Testicular Germ Cell Tumor
Procedure: positron emission tomography
Radiation: fludeoxyglucose F 18

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Diagnostic
Official Title: A Study Of 18 FDG PET In The Prediction Of Relapse In Patients With A Clinical Stage I Non-Seminomatous Germ Cell Tumor

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 2002
Study Completion Date: July 2007
Detailed Description:


  • 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 schedule.

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 years.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed non-seminomatous or mixed seminoma/non-seminomatous germ cell tumor of the testis with evidence of vascular (lymphatic or venous) invasion in primary specimen
  • Clinical stage I on the basis of clinical examination, chest x-ray, and CT scan of the chest, abdomen, and pelvis
  • Negative post-orchidectomy tumor markers (alpha-fetoprotein and beta human chorionic gonadotropin)
  • High-risk disease



  • Any age

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • No evidence of active inflammatory or infective diseases
  • No other disease or prior malignancy that would preclude study


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • See Disease Characteristics
  • No more than 8 weeks since prior orchidectomy


  • No prior positron emission tomography scans
  Contacts and Locations
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Please refer to this study by its identifier: NCT00045045

United Kingdom
Royal Devon and Exeter Hospital
Exeter, England, United Kingdom, EX2 5DW
Ipswich Hospital NHS Trust
Ipswich, England, United Kingdom, IP4 5PD
Guy's and St. Thomas' Hospitals NHS Foundation Trust
London, England, United Kingdom, SE1 9RT
Meyerstein Institute of Oncology at University College of London Hospitals
London, England, United Kingdom, WIT 3AA
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom, NG5 1PB
Royal South Hants Hospital
Southampton, England, United Kingdom, 5O14OYG
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom, SM2 5PT
Beatson Oncology Centre
Glasgow, Scotland, United Kingdom, G11 6NT
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Study Chair: Robert A. Huddart, MD Royal Marsden NHS Foundation Trust
  More Information

Publications: Identifier: NCT00045045     History of Changes
Other Study ID Numbers: CDR0000256314
Study First Received: September 6, 2002
Last Updated: December 17, 2013

Keywords provided by National Cancer Institute (NCI):
stage I malignant testicular germ cell tumor
testicular choriocarcinoma
testicular choriocarcinoma and embryonal carcinoma
testicular choriocarcinoma and seminoma
testicular choriocarcinoma and teratoma
testicular choriocarcinoma and yolk sac tumor
testicular embryonal carcinoma and seminoma
testicular embryonal carcinoma and teratoma with seminoma
testicular embryonal carcinoma and teratoma
testicular embryonal carcinoma and yolk sac tumor with seminoma
testicular embryonal carcinoma and yolk sac tumor
testicular embryonal carcinoma
testicular teratoma
testicular yolk sac tumor and teratoma with seminoma
testicular yolk sac tumor and teratoma
testicular yolk sac tumor

Additional relevant MeSH terms:
Neoplasms, Germ Cell and Embryonal
Testicular Neoplasms
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases
Gonadal Disorders
Fluorodeoxyglucose F18
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017