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

Sponsored by:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00620243

Purpose

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.

Condition	Intervention	Phase
Ovarian Cancer	Procedure: 1: FDG PET	Phase 0

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment, Safety/Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Cancer Ovarian Cancer

Drug Information available for: Fluorodeoxyglucose F18

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Enrollment:	9
Study Start Date:	June 2004
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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 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.

Arms

Assigned Interventions

1: Experimental

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

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620243

Locations

United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Neeta Pandit-Taskar, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Neeta Pandit-Taskar, MD )
Study ID Numbers:	04-064
Study First Received:	January 25, 2008
Last Updated:	February 19, 2008
ClinicalTrials.gov Identifier:	NCT00620243 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Ovarian cancer
PET
CT
04-064

Study placed in the following topic categories:

Genital Diseases, Female
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Ovarian Cancer

Endocrine System Diseases
Urogenital Neoplasms
Endocrinopathy
Ovarian Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Genital Diseases, Female
Neoplasms
Neoplasms by Site
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female

Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on September 04, 2009