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Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Subjects With Pituitary Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Endocyte
ClinicalTrials.gov Identifier:
NCT01689727
First received: September 9, 2012
Last updated: September 17, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Pituitary Tumors
 Drug: Technetium Tc 99m EC20
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Clinical Study to Evaluate the Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Subjects With Pituitary Tumors

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Endocyte:

Enrollment: 40
Study Start Date: September 2002
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Technetium Tc 99m EC20 Drug: Technetium Tc 99m EC20

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01689727

Locations
United States, Georgia
Emory Hospital
Atlanta, Georgia, United States
Sponsors and Collaborators
Endocyte
Investigators
Principal Investigator: Nelson Oyesiku, MD Emory Hospital
  More Information

No publications provided

Responsible Party: Endocyte
ClinicalTrials.gov Identifier: NCT01689727     History of Changes
Other Study ID Numbers: EC20.7
Study First Received: September 9, 2012
Last Updated: September 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Endocyte:
Pituitary Tumors

Additional relevant MeSH terms:
Pituitary Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
 Nervous System Neoplasms
Pituitary Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hypothalamic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on June 18, 2013