NCT01689662

Brief Summary

The folate receptor (FR) is overexpressed by many different cancer types, including renal cell carcinoma. Besides helping in the diagnosis of cancer, a folate-targeted imaging agent could provide an effective method to identify folate receptor-positive (FR+) cancer patients that may benefit from folate-targeted therapy. Up to 40 subjects, with known or strongly suspected metastatic renal cell carcinoma with at least one target lesion detected by a diagnostic imaging procedure (e.g. ultrasonography, CT, or MRI), will be enrolled in this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2002

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

August 1, 2002

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
9.2 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

June 22, 2023

Status Verified

September 1, 2012

First QC Date

September 9, 2012

Last Update Submit

June 20, 2023

Conditions

Metastatic Renal Cell Carcinoma

Keywords

Metastatic Renal Cell Carcinoma

Study Arms (1)

Tc 99m EC20

EXPERIMENTAL

Subjects will receive two intravenous injections 1-3 minutes apart: 1. 1 mg of folic acid 2. 1-2 mL injection of 0.1 mg of EC20 labeled with 15-25 mCi of technetium-99m

Drug: Tc 99m EC20

Interventions

Tc 99m EC20DRUG
Tc 99m EC20

Eligibility Criteria

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

You may qualify if:

  • Subjects must meet the following eligibility requirements to be enrolled in the study.
  • Subject must be 18 years of age or older.
  • Subject must have known or strongly suspected metastatic renal cell carcinoma with at least one target lesion as identified by ultrasonography, MRI, or CT.
  • Subject must have good kidney function.
  • Subject must provide written informed consent prior to enrollment.

You may not qualify if:

  • Subjects must be excluded if any of the following conditions are present:
  • Subject is pregnant or breastfeeding.
  • Subject is simultaneously participating in another investigational drug study, excluding the follow-up phase.
  • Subject has received an investigational agent within 7 days prior to enrollment.
  • Subject is unable to tolerate conditions for radionuclide imaging.
  • Subject 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 (1)

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

August 1, 2002

Study Completion

July 1, 2003

Last Updated

June 22, 2023

Record last verified: 2012-09

Locations

US(1)