NCT01689766

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

Trial Health

80
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 21, 2012

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

4 years

First QC Date

September 9, 2012

Last Update Submit

July 24, 2023

Conditions

Metastatic Renal Cell Carcinoma

Keywords

Renal Cell

Study Arms (1)

Technetium Tc 99m EC20

OTHER
Drug: Technetium Tc 99m EC20

Interventions

Technetium Tc 99m EC20DRUG
Technetium Tc 99m EC20

Eligibility Criteria

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

You may qualify if:

  • To be eligible for the study, patients must fulfill all of the following criteria:
  • Patient must be 18 years of age or older.
  • Patient must have suspected metastatic renal cell carcinoma with at least one identifiable lesion \>2.0 cm as diagnosed by CT, MRI, or ultrasonography within 60 days prior to enrollment.
  • Patient must have good kidney function defined as a serum creatinine ≤1.5 X ULN.
  • Patient must provide written informed consent prior to enrollment.
  • Patients must provide a formalin-fixed, paraffin-embedded tissue sample of either the primary or metastatic or recurrent site(s) for IHC staining for the presence of folate receptors from either a previous surgical/biopsy procedure or from a surgery/biopsy scheduled within 30 days of FolateScan. A fine needle aspirate is not acceptable.

You may not qualify if:

  • Any of the following criteria will make the patient ineligible to participate in this study:
  • Patient is pregnant or breastfeeding.
  • Patient is simultaneously participating in another investigational drug study, excluding the follow-up phase.
  • Patient has received an investigational agent or therapeutic chemotherapy within 7 days prior to enrollment.
  • Patient is unable to tolerate conditions for radionuclide imaging.
  • Patient has been administered another radiopharmaceutical that would interfere with the assessment of Technetium Tc 99m EC20.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2012

First Posted

September 21, 2012

Study Start

November 1, 2003

Primary Completion

November 1, 2007

Last Updated

July 25, 2023

Record last verified: 2023-07

Locations

US(2)