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

A Multicenter Trial to Measure Early Patterns of Change in [18F]-Fluorodeoxyglucose Uptake by PET/CT in Relapsed Ovarian Cancer Patients

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00959582

Enrollment

Registered

2009-08-14

Start date

2009-09-30

Completion date

2011-10-31

Last updated

2015-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cancer

Keywords

Relapsed ovarian cancer

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.

Interventions

PROCEDUREComparator: 18-F-FDG PET/CT and Volumetric CT

Patients will receive standard-of-care therapy (carboplatin or cisplatin monotherapy, or a two-drug combination where one is platinum). FDG-PET/CT scans will be performed at baseline following enrollment, after Cycles 1 and 2 of chemotherapy, and if patients are progression-free at the end of Cycle 6. Volumetric CT scans will be performed at baseline following enrollment, after Cycles 1 and 2 of chemotherapy, after Cycle 3 of chemotherapy (optional), and if patients are progression-free at the end of Cycle 6 and at 40 weeks after Cycle 1 dosing.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

35 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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	Baseline, Week 3, Week 6
Progression free proportion	40 Weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026