Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045045
Status:
COMPLETED
Last Update Posted:
2013-12-18
First Post:
2002-09-06
Brief Title:
Positron Emission Tomography in Detecting Testicle Cancer
Sponsor:
Institute of Cancer Research United Kingdom
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2002-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 seminomanon-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
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 seminomanon-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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20115 | None | None | None |
| MRC-TE22 | None | None | None |