NCT00003763

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable ovarian-cancer

Timeline
Completed

Started Dec 1997

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 8, 1997

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2000

Completed
4.2 years until next milestone

First Posted

Study publicly available on registry

July 22, 2004

Completed
Last Updated

September 30, 2021

Status Verified

September 1, 2021

Enrollment Period

2.4 years

First QC Date

November 1, 1999

Last Update Submit

September 24, 2021

Conditions

Ovarian Cancer

Keywords

stage I ovarian epithelial cancerstage II ovarian epithelial cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancerrecurrent ovarian epithelial cancerovarian stromal cancerstage I ovarian germ cell tumorstage II ovarian germ cell tumorstage III ovarian germ cell tumorstage IV ovarian germ cell tumorrecurrent ovarian germ cell tumorborderline ovarian surface epithelial-stromal tumorovarian sarcoma

Interventions

radionuclide imagingPROCEDURE
indium In 111 folic acidRADIATION

Eligibility Criteria

Age18 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5265, United States

Location

Washington University - St. Louis

St Louis, Missouri, 63110, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

Indium

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsMetals

Study Officials

  • David M. Gershenson, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
DIAGNOSTIC
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 1, 1999

First Posted

July 22, 2004

Study Start

December 8, 1997

Primary Completion

May 3, 2000

Study Completion

May 3, 2000

Last Updated

September 30, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(3)