Spots Global Cancer Trial Database for Study Using FolateScan to Identify Subjects With Folate Receptor-Positive Metastatic Renal Cell Carcinoma

Study Description

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

Detailed Description: 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).

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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