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Technetium Tc 99m-ethylenedicysteine

Radiopharmaceuticals

Technetium Tc 99m EC20

Nelson Oyesiku, MD

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.

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.

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

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

Endocyte

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

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Adenocarcinoma

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Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Micronutrients

Hematinics

Vitamins

Folic Acid

Vitamin B Complex

Folinic Acid

Folate

Vitamin B9

Phase 2, multi-center, open-label, single-treatment group, baseline-controlled study to identify subjects with Folate Receptor-Positive Metastatic Renal Cell Carcinoma

The investigational new drug (FolateScan or Technetium Tc 99m EC20) is a folate-targeted diagnostic radiopharmaceutical agent designed to bind to the folate receptor. The folate receptor is a glycoprotein that is over-expressed in many types of cancer cells but it is only minimally distributed in normal tissues . Folate conjugates bind to the folate receptor with high affinity and are brought into the cell via endocytosis. In contrast, folic acid itself enters most normal cells via the reduced folate carrier, a pathway entirely inaccessible to folate conjugates. Therefore, these folate conjugates are specific to cancer cells.

This is a phase 2, multi-center, open-label, single-treatment group, baseline-controlled study designed to verify product safety, gather data on the percentage of metastatic renal cell carcinoma patients with increased uptake of FolateScan in tumors, and to calculate sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of FolateScan compared to immunohistochemical staining (IHC).

Study Using FolateScan to Identify Subjects With Folate Receptor-Positive Metastatic Renal Cell Carcinoma

A Screening Study Using FolateScan to Identify Subjects With Folate Receptor-Positive Metastatic Renal Cell Carcinoma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Subjects With Pituitary Tumors	NCT01689727	Pituitary Tumor...	Technetium Tc 9...	18 Years -	Endocyte
Study Using FolateScan to Identify Subjects With Folate Receptor-Positive Metastatic Renal Cell Carcinoma	NCT01689766	Metastatic Rena...	Technetium Tc 9...	18 Years -	Endocyte
Study Using FolateScan to Identify Subjects With Folate Receptor-Positive Metastatic Renal Cell Carcinoma	NCT01689766	Metastatic Rena...	Technetium Tc 9...	18 Years -	Endocyte

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