Positron Emission Tomography in Detecting Testicle Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00045045
First received: September 6, 2002
Last updated: December 17, 2013
Last verified: September 2002
  Purpose

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:

OBJECTIVES:

  • 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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • Any age

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

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

Other

  • No prior positron emission tomography scans
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00045045

Locations
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
Investigators
Study Chair: Robert A. Huddart, MD Royal Marsden NHS Foundation Trust
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00045045     History of Changes
Other Study ID Numbers: CDR0000256314, MRC-TE22, EU-20115
Study First Received: September 6, 2002
Last Updated: December 17, 2013
Health Authority: United States: Federal Government

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
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Male
Genital Neoplasms, Male
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Testicular Diseases
Urogenital Neoplasms
Fluorodeoxyglucose F18
Diagnostic Uses of Chemicals
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiopharmaceuticals

ClinicalTrials.gov processed this record on October 23, 2014