Brief Title
Positron Emission Tomography/Computed Tomography (PET/CT) in Relapsed Ovarian Cancer (MK-0000-143)
Official Title
A Multicenter Trial to Measure Early Patterns of Change in [18F]-Fluorodeoxyglucose Uptake by PET/CT in Relapsed Ovarian Cancer Patients
Brief Summary
This study will characterize FDG-PET (18F-Fluorodeoxyglucose-Positron Emission Tomography) as an early response marker in recurrent, platinum-sensitive ovarian cancer treated with platinum-based therapy.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Proportion of patients with metabolic non-response assessed by FDG-PET standardized uptake value (SUV) 3 weeks and 6 weeks after starting platinum-based therapy
Condition
Ovarian Cancer
Intervention
Comparator: 18-F-FDG PET/CT and Volumetric CT
Study Arms / Comparison Groups
1
Description: 18-F-FDG PET/CT imaging
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
42
Start Date
September 2009
Completion Date
October 2011
Primary Completion Date
October 2011
Eligibility Criteria
Inclusion Criteria: - Patient has ovarian, primary peritoneal, or fallopian tube cancer - Patient has first or subsequent relapse - Patient has had at least on prior platinum-based treatment for ovarian cancer - Patient is scheduled to receive treatment with carboplatin or cisplatin monotherapy or combination where one of the drugs is a platinum - Patient is not pregnant Exclusion Criteria: - Patient has had abdominal surgery within the last 6 weeks - Patient has life expectancy < 6 months - Patient has had radiotherapy to the abdomen or pelvis within the last 6 months - Patient has poorly controlled diabetes
Gender
Female
Ages
35 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Medical Monitor, ,
Administrative Informations
NCT ID
NCT00959582
Organization ID
0000-143
Secondary IDs
2009_632
Responsible Party
Sponsor
Study Sponsor
Merck Sharp & Dohme Corp.
Study Sponsor
Medical Monitor, Study Director, Merck Sharp & Dohme Corp.
Verification Date
January 2015