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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.


Phase 0
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome 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.

Outcome Time Frame:

Conclusion of the study

Safety Issue:

No

Principal Investigator

Neeta Pandit-Taskar, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

04-064

NCT ID:

NCT00620243

Start Date:

June 2004

Completion Date:

November 2008

Related Keywords:

  • Ovarian Cancer
  • Ovarian cancer
  • PET
  • CT
  • 04-064
  • Ovarian Neoplasms

Name

Location
Memorial Sloan Kettering Cancer Center New York, New York  10021