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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Completed; Early Phase 1

Conditions: Ovarian Cancer

Treatments: Procedure: 1: FDG PET

Study type: Interventional

Funder types: Other

Identifiers

NCT00620243

04-064

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

1

Experimental group

Description:

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.

Treatment:

Procedure: 1: FDG PET