Viewing Study NCT00003763



Ignite Creation Date: 2024-05-05 @ 11:07 AM
Last Modification Date: 2024-10-26 @ 9:04 AM
Study NCT ID: NCT00003763
Status: COMPLETED
Last Update Posted: 2021-09-30
First Post: 1999-11-01

Brief Title: Radiolabeled Folic Acid and Imaging to Detect Ovarian Cancer
Sponsor: Endocyte
Organization: Endocyte

Study Overview

Official Title: A Study to Determine the Ability of Folate Conjugates to Target Folate Receptors in Ovarian Cancer Tumors
Status: COMPLETED
Status Verified Date: 2021-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
Detailed Description: 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 eg 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
CDR0000066889 REGISTRY None None
ENDOCYTE-96-286 None None None
ENDOCYTE-98-0409 Registry Identifier PDQ Physician Data Query None