Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-02-20 @ 4:49 PM
Study NCT ID:
NCT01689766
Status:
COMPLETED
Last Update Posted:
2023-07-25
First Post:
2012-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Using FolateScan to Identify Subjects With Folate Receptor-Positive Metastatic Renal Cell Carcinoma
Sponsor:
Endocyte
Organization:
Study Overview
Official Title:
A Screening Study Using FolateScan to Identify Subjects With Folate Receptor-Positive Metastatic Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2023-07
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:
Phase 2, multi-center, open-label, single-treatment group, baseline-controlled study to identify subjects with Folate Receptor-Positive Metastatic Renal Cell Carcinoma
Detailed Description:
The investigational new drug (FolateScan or Technetium Tc 99m EC20) is a folate-targeted diagnostic radiopharmaceutical agent designed to bind to the folate receptor. The folate receptor is a glycoprotein that is over-expressed in many types of cancer cells but it is only minimally distributed in normal tissues . Folate conjugates bind to the folate receptor with high affinity and are brought into the cell via endocytosis. In contrast, folic acid itself enters most normal cells via the reduced folate carrier, a pathway entirely inaccessible to folate conjugates. Therefore, these folate conjugates are specific to cancer cells.
This is a phase 2, multi-center, open-label, single-treatment group, baseline-controlled study designed to verify product safety, gather data on the percentage of metastatic renal cell carcinoma patients with increased uptake of FolateScan in tumors, and to calculate sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of FolateScan compared to immunohistochemical staining (IHC).
This is a phase 2, multi-center, open-label, single-treatment group, baseline-controlled study designed to verify product safety, gather data on the percentage of metastatic renal cell carcinoma patients with increased uptake of FolateScan in tumors, and to calculate sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of FolateScan compared to immunohistochemical staining (IHC).
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: