Safety And Efficacy Of FalateScan (Technetium Tc 99m EC20) In Patients With Known Suspected Recurrent Or Metastatic Cancer From A Solid Tumor

Study Overview

Safety and Efficacy of FalateScan (Technetium Tc 99m EC20) in Patients With Known Suspected Recurrent or Metastatic Cancer From a Solid Tumor

The folate receptor is over-expressed on many types of cancer cells and new folate receptor targeted therapies are being developed to target cancer cells that over-express the folate receptor. As with other targeted therapies, it is important to develop diagnostic tests that will provide accurate information on folate receptor status and aid in selecting patients that may benefit from folate-targeted therapy.

This Phase II, limited institution, open-label, single-arm, baseline-controlled study is designed to obtain data on the percentage of patients with recurrent or metastatic cancer from a solid tumor (including, but not limited to, breast, lung, mesothelioma, liver, colorectal, prostate, head and neck, pancreas, bladder and testicular cancer) with increased uptake of FalateScan in tumors, correlate the immunohistochemical staining findings with the FolateScan images, and verify product safety in patients with suspected recurrent or metastatic disease from any solid tumor.

Recurrent or Metastatic Cancer
Head and Neck Cancer
Pancreas Cancer
Bladder Cancer
Testicular Cancer

DRUG: Tc 99m EC20

EC20.8

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2012-09-09	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-06-20
First Submitted that Met QC Criteria 2012-09-09	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-06-22
First Posted (ACTUAL) 2012-09-12	Results First Posted N/A	Last Verified 2012-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Other

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
OTHER: Tc 99m EC20	DRUG: Tc 99m EC20

Participant Group/Arm

Intervention/Treatment

OTHER: Tc 99m EC20

DRUG: Tc 99m EC20

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Patients must meet the following eligibility requirements to be enrolled in the study:

Exclusion Criteria:

Patients must be excluded in any of the following conditions are present:

1. Patient is pregnant or breastfeeding. 2. Patient is simultaneously participating in another investigational drug study, excluding the follow-up phase. 3. Patient has received an investigational agent within 7 days prior to enrollment. 4. Patient is unable to tolerate conditions for radionuclide imaging. 5. Patient has been administered another radiopharmaceutical that would interfere with the assessment of Technetium Tc 99m EC20.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Nelson M Oyesiku, MD, PhD, Emory University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record