Pilot Study to Evaluate 18F-fluorodeoxyglucose (FDG) Positron Emission Tomography /Computed Tomography (PET/CT) in Prediction of Early Response to Chemotherapy in Ovarian Cancer.

Early Phase 1CompletedNCT00620243

Memorial Sloan Kettering Cancer Center9 enrolled

Overview

We hypothesize that 18FDG Positron Emission Tomography (FDG PET) imaging, carried out after the first cycle of chemotherapy, will identify responders, thus permitting early termination of potential toxic therapy in non- responders leading to a significant decrease in morbidity and cost. The value of PET imaging as an early predictor of response to chemotherapy has been shown in other cancers.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Ovarian Cancer

Interventions

1: FDG PETPROCEDURE

The study will evaluate the potential of PET imaging to identify early responders to chemotherapy. Patients entered into this study will undergo FDG PET within 2 weeks prior to chemotherapy and prior to initiation of the second course of chemotherapy. All images will be carried out in the same manner with respect to equipment, acquisition parameters, and time post injection, to ensure that changes in standard uptake value(SUV) correlate with metabolic changes. This will be correlated with response determined by changes in serum CA 125 levels.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically proven ovarian cancer at diagnosis of any stage. * Patients with evidence of disease that is radiographically measurable (CT scan) * Patients have planned to undergo standard chemotherapy. Dose and schedule will be determined per treating physician Exclusion Criteria: * Patients with any other malignancy active within 5 years except for non-melanoma skin cancer, or carcinoma in situ of the cervix. * Patients with an active infection * Patients of childbearing potential are excluded from this study. * Patients who have expected survival \< 3 months. * Patients not planning or able to receive the outlined chemotherapy regimen as part of standard practice. * Patient unable to complete study

Outcomes

Primary Outcomes

Partial metabolic response (PMR) - A reduction of a minimum of 15-25% in tumour 18FDG SUV after one cycle of chemotherapy, and greater than 25% after more than one treatment cycle.

Time frame: Conclusion of the study

Partial metabolic response (PMR) - A reduction of a minimum of 15-25% in tumour 18FDG SUV after one cycle of chemotherapy, and greater than 25% after more than one treatment cycle.

Time frame: Completion of study

Complete metabolic response (CMR) - Complete resolution of 18FDG uptake within the tumour volume so that it was indistinguishable from surrounding normal tissue.

Time frame: completion of study

Progressive metabolic disease- increase in 18FDG tumour SUV of greater than 25% within tumour region defined on the baseline scan, visible increase in the extent of 18FDG tumour uptake (>20% in the longest dimension).

Time frame: completion of study

Stable metabolic disease (SMD) -An increase in tumour 18FDG SUV of less than 25% or a decrease of less than 15% and no visible increase in extent of 18FDG uptake in tumor (>20% in the longest dimension).

Time frame: completion of study

Pilot Study to Evaluate 18F-fluorodeoxyglucose (FDG) Positron Emission Tomography /Computed Tomography (PET/CT) in Prediction of Early Response to Chemotherapy in Ovarian Cancer.

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes