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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01689727
Other study ID # EC20.7
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 2002

Study information

Verified date September 2012
Source Endocyte
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Many types of cancers overexpress a receptor for the vitamin folate (Folate Receptor). This Phase 2 study will utilize a standard imaging radionuclide, technetium-99m, conjugated to a ligand (EC20) designed to bind to the folate receptor. The study is designed as an open-label, baseline-controlled study.


Description:

This is a Phase 2 open-label, single-treatment group, baseline-controlled study designed to verify product safety, gather data on the percentage of subjects with pituitary tumors with increased uptake of FolateScan in tumors and correlate the immunohistochemical staining findings with the FolateScan images, in subjects with pituitary tumors.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date
Est. primary completion date September 2004
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Subjects must meet the following eligibility requirements to be enrolled in the study: 1. Subject must be 18 years of age or older. 2. Subject must have a pituitary tumor. 3. Subject must have good kidney function. 3. Subject must provide written informed consent prior to enrollment. Exclusion Criteria: Subjects must be excluded if any of the following conditions are present: 1. Subject is pregnant or breastfeeding. 2. Subject is simultaneously participating in another investigational drug study. 3. Subject has completed the follow-up phase of any previous study loess than 30 days prior to enrollment in this study. 4. Subject is unable to tolerate conditions for radionuclide imaging. 5. Subject has been administered another radiopharmaceutical that would interfere with the assessment of Technetium Tc 99m EC20.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Technetium Tc 99m EC20


Locations

Country Name City State
United States Emory Hospital Atlanta Georgia

Sponsors (1)

Lead Sponsor Collaborator
Endocyte

Country where clinical trial is conducted

United States, 

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