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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00620243
• Other study ID #: 04-064
• Status: Completed
• Phase: Phase 0
• First received: January 25, 2008
• Last updated: January 6, 2012
• Start date: June 2004
• Est. completion date: November 2008

Study information

• Verified date: January 2012
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Procedure:
• 1: FDG PET
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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No

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