Positron Emission Tomography in Detecting Testicle Cancer

Testicular Germ Cell Tumor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00045045
• Other study ID #: CDR0000256314
• Secondary ID: MRC-TE22EU-20115
• Status: Completed
• Phase: N/A
• First received: September 6, 2002
• Last updated: December 17, 2013
• Start date: May 2002
• Est. completion date: July 2007

Study information

• Verified date: September 2002
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Neoplasms, Germ Cell and Embryonal
• Testicular Germ Cell Tumor
• Testicular Neoplasms

Intervention

Procedure:
• positron emission tomography

Radiation:
• fludeoxyglucose F 18

Locations

Country	Name	City	State
United Kingdom	Royal Devon and Exeter Hospital	Exeter	England
United Kingdom	Beatson Oncology Centre	Glasgow	Scotland
United Kingdom	Ipswich Hospital NHS Trust	Ipswich	England
United Kingdom	Guy's and St. Thomas' Hospitals NHS Foundation Trust	London	England
United Kingdom	Meyerstein Institute of Oncology at University College of London Hospitals	London	England
United Kingdom	Nottingham City Hospital NHS Trust	Nottingham	England
United Kingdom	Royal South Hants Hospital	Southampton	England
United Kingdom	Royal Marsden NHS Foundation Trust - Surrey	Sutton	England

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Cancer Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Huddart RA, O'Doherty MJ, Padhani A, Rustin GJ, Mead GM, Joffe JK, Vasey P, Harland SJ, Logue J, Daugaard G, Hain SF, Kirk SJ, MacKewn JE, Stenning SP; NCRI Testis Tumour Clinical Study Group. 18fluorodeoxyglucose positron emission tomography in the predi — View Citation