Radiolabeled Folic Acid and Imaging to Detect Ovarian Cancer
|First Received Date ICMJE||November 1, 1999|
|Last Updated Date||February 6, 2009|
|Start Date ICMJE||January 1999|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00003763 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Radiolabeled Folic Acid and Imaging to Detect Ovarian Cancer|
|Official Title ICMJE||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.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Primary Purpose: Diagnostic|
|Condition ICMJE||Ovarian Cancer|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Enrollment ICMJE||Not Provided|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00003763|
|Other Study ID Numbers ICMJE||CDR0000066889, ENDOCYTE-EC.OV.53.958, ENDOCYTE-96-286, ENDOCYTE-98-0409|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Endocyte|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Cancer Institute (NCI)|
|Verification Date||April 1999|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP