Positron Emission Tomography in Detecting Testicle Cancer

Sponsor

Institute of Cancer Research, United Kingdom (Other)

Overall Status

Completed

CT.gov ID

NCT00045045

Collaborator

(none)

Locations

Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Testicular Germ Cell Tumor	Procedure: positron emission tomography Radiation: fludeoxyglucose F 18	N/A

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.

Study Design

Study Type:

Interventional

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

Study Start Date :

May 1, 2002

Actual Study Completion Date :

Jul 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Royal Devon and Exeter Hospital	Exeter	England	United Kingdom	EX2 5DW
2	Ipswich Hospital NHS Trust	Ipswich	England	United Kingdom	IP4 5PD
3	Guy's and St. Thomas' Hospitals NHS Foundation Trust	London	England	United Kingdom	SE1 9RT
4	Meyerstein Institute of Oncology at University College of London Hospitals	London	England	United Kingdom	WIT 3AA
5	Nottingham City Hospital NHS Trust	Nottingham	England	United Kingdom	NG5 1PB
6	Royal South Hants Hospital	Southampton	England	United Kingdom	5O14OYG
7	Royal Marsden NHS Foundation Trust - Surrey	Sutton	England	United Kingdom	SM2 5PT
8	Beatson Oncology Centre	Glasgow	Scotland	United Kingdom	G11 6NT