Radiolabeled Folic Acid and Imaging to Detect Ovarian Cancer



Status:Completed
Conditions:Ovarian Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 120
Updated:4/5/2017
Start Date:January 1999

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A Study to Determine the Ability of Folate Conjugates to Target Folate Receptors in Ovarian Cancer Tumors

RATIONALE: Diagnostic procedures using the drug radiolabeled folic acid and imaging may be
effective in detecting ovarian cancer.

PURPOSE: Diagnostic trial to study the effectiveness of radiolabeled folic acid plus imaging
in detecting ovarian cancer.

OBJECTIVES: I. Evaluate the effectiveness of folic acid conjugated with indium In 111 to
diagnose ovarian cancer and locate metastatic disease.

OUTLINE: This is a diagnostic study. Patients receive an injection of folic acid conjugated
with indium In 111. The patient then undergoes imaging studies at various time points (e.g.,
1, 4, and 24 hours). Patients then undergo exploratory surgery, the results of which are
then compared to the imaging studies.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

DISEASE CHARACTERISTICS: Suspected ovarian cancer OR Recurrence of ovarian cancer
Scheduled for exploratory surgery

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy:
Not specified Hematopoietic: WBC at least 3000/mm3 Granulocyte count at least 1500/mm3
Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no
greater than 2.0 mg/dL SGPT and SGOT no greater than 2 times upper limit of normal (ULN)
Alkaline phosphatase no greater than 2 times ULN No acute hepatitis Renal: Creatinine no
greater than 1.4 mg/dL BUN no greater than 1.5 times ULN No known or suspected kidney
disease Cardiovascular: No history of congestive heart failure No unstable angina No
myocardial infarction within 6 months Other: Not pregnant or nursing No septicemia or
severe infection No medical condition that would preclude the administration of large
fluid volumes over a short period of time

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 months
since prior cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: At least
3 months since prior radiotherapy Surgery: See Disease Characteristics Other: At least 2
days since prior folic acid supplements At least 5 days since nonsteroidal
antiinflammatory medications
We found this trial at
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sites
St. Louis, Missouri 63110
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Indianapolis, Indiana 46202
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Indianapolis, IN
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