Clinical trial NCT00620243: Pilot Study to Evaluate 18F-fluorodeoxyglucose (FDG) Positron Emission Tomography /Computed Tomography (PET/CT) in Prediction of Early Response to Chemotherapy in Ovarian Cancer.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Ovarian Cancer
Keywords: Ovarian cancer
PET
CT
04-064
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-02-21
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Conclusion of the study
measure: 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.
timeFrame: Completion of study
measure: Complete metabolic response (CMR) - Complete resolution of 18FDG uptake within the tumour volume so that it was indistinguishable from surrounding normal tissue.
timeFrame: completion of study
measure: 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).
timeFrame: completion of study
measure: 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).
timeFrame: completion of study
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Neeta Pandit-Taskar, MD
role: PRINCIPAL_INVESTIGATOR
References: