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

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.

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Key information

Conditions

Pituitary Tumors Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Hypothalamic Diseases Hypothalamic Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Pituitary Diseases Pituitary Neoplasms Supratentorial Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Emory Hospital

Atlanta, Georgia, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 a pituitary tumor.
Subject must have good kidney function.

Subject must provide written informed consent prior to enrollment.

Exclusion criteria

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.
Subject has completed the follow-up phase of any previous study loess than 30 days prior to enrollment in this study.
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.

Treatment and study plan

Technetium Tc 99m EC20

Drug

Sponsors and collaborators

Lead sponsor

Endocyte

Industry

Registry information

Official study title

A Clinical Study to Evaluate the Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Subjects With Pituitary Tumors

Important dates

Study start: 2002
Primary completion: 2004
First posted: Sep 21, 2012
Registry last updated: Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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