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Radiolabeled Folic Acid and Imaging to Detect Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by:
Endocyte
ClinicalTrials.gov Identifier:
NCT00003763
First received: November 1, 1999
Last updated: April 3, 2017
Last verified: April 2017
November 1, 1999
April 3, 2017
January 1999
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Complete list of historical versions of study NCT00003763 on ClinicalTrials.gov Archive Site
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Radiolabeled Folic Acid and Imaging to Detect Ovarian Cancer
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.

Interventional
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Primary Purpose: Diagnostic
Ovarian Cancer
  • Procedure: radionuclide imaging
  • Radiation: indium In 111 folic acid
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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

Sexes Eligible for Study: Female
18 Years to 120 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00003763
ENDOCYTE-EC.OV.53.958
CDR0000066889 ( Registry Identifier: PDQ (Physician Data Query) )
ENDOCYTE-96-286
ENDOCYTE-98-0409
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Not Provided
Endocyte
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Study Chair: David M. Gershenson, MD M.D. Anderson Cancer Center
Endocyte
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP