Positron Emission Tomography/Computed Tomography (PET/CT) in Relapsed Ovarian Cancer (MK-0000-143)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Primary Peritoneal Cancer; Fallopian Tube Cancer; Ovarian Cancer

Treatments: Procedure: Comparator: 18-F-FDG PET/CT and Volumetric CT

Study type: Interventional

Funder types: Industry

Identifiers

NCT00959582

0000-143

2009_632

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: Female

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

1

Experimental group

Description:

18-F-FDG PET/CT imaging

Treatment:

Procedure: Comparator: 18-F-FDG PET/CT and Volumetric CT