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

Study Overview
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Brief Summary
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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.

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

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Procedure: 1: FDG PET


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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. | Procedure: 1: FDG PET<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 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. |  | 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. |  | 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). |  | 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). |  | completion of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian cancer, PET, CT, 04-064