Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Micronutrients

Hematinics

All Drugs and Chemicals

Vitamins

Folic Acid

Vitamin B Complex

Technetium Tc 99m-ethylenedicysteine

Radiopharmaceuticals

Folinic Acid

Folate

Vitamin B9

The study was designed as a single-center, open-label clinical study to evaluate the safety, pharmacokinetics, dosimetry and metabolism of Tc 99m EC20 in normal volunteers and in patients with known or suspected ovarian cancer.

Eight subjects were to be enrolled at one center: four normal subjects, four patients with ovarian cancer. Each subject was to receive a single injection of Tc 99m EC20 complex composed of 0.1 mg ligand (EC20) and 15 - 20 mCi of Tc 99m. Two (2) of the 4 normal subjects and 2 of the 4 patients were to receive an injection of 0.25-2.0 mg folic acid 1-2 minutes prior to the injection of Tc 99m EC20.

Tc 99m EC20

Open-label, single-center, single-treatment group, baseline-controlled (for safety) study of the safety and biodistribution of Technetium Tc 99m EC20 in four normal subjects and four subjects with known or suspected ovarian cancer.

This was a single-center, open-label evaluation of a single injection of Tc 99m EC20 containing 0.1 mg EC20 labeled with 15 - 20 mCi of technetium-99m in normal volunteers and patients with known or suspected ovarian cancer. Two normal volunteers and two patients also were to receive an injection of 0.25 - 2.0 mg folic acid 1 to 2 minutes prior to the injection of Tc 99m EC20. Serial blood samples and urine were collected during the 24-hour period following each injection for pharmacokinetic evaluation. Serial whole body images were acquired during the 24-hour postdose period for dosimetry evaluations. Safety was monitored through predose and postdose physical examinations, electrocardiograms (ECGs), vital signs and clinical laboratory evaluations. Adverse events were monitored from the time of signing of Informed Consent to 24 hours postdose.

Safety and Biodistribution of Technetium Tc 99m EC20 in Normal Volunteers and Ovarian Cancer Patients

CLINICAL STUDY OF A SINGLE-CENTER CLINICAL STUDY TO EVALUATE THE SAFETY AND BIODISTRIBUTION OF TECHNETIUM Tc 99m EC20 IN NORMAL VOLUNTEERS AND OVARIAN CANCER PATIENTS

Endocyte

Endometrial Neoplasms

Uterine Neoplasms

Uterine Diseases

A Phase 1, multi-center, open-label, single-treatment group, baseline-controlled (for safety) study designed to verify product safety, determine optimal imaging time, gather efficacy data for the radioactive drug product (Technetium Tc 99m EC20), and assay masses for presence of folate receptors, in women with suspected ovarian or endometrial cancer. Twelve subjects will be enrolled, with a minimum of five malignant cases, as determined by histopathological evaluation.

Each subject will receive 1 mg of folic acid injected 1-3 minutes prior to administration of Technetium Tc 99m EC20.

James W. Fletcher, MD

A Multi-Center Clinical Study to Evaluate the Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Women with Suspected Ovarian or Endometrial Cancer.

Phase I - The proposed indication for FolateScan is disease or pathological assessment of ovarian or endometrial masses.

The study is designed to verify product safety, determine optimal imaging time, gather efficacy data for the radioactive drug product (Technetium Tc 99m EC20), and assay masses for presence of folate receptors, in women with suspected ovarian or endometrial cancer. Twelve subjects will be enrolled, with a minimum of five malignant cases, as determined by histopathological evaluation.

Women with a suspected ovarian or endometrial mass who either 1) have fixed, paraffin embedded tissue sample(s) available for immunohistochemical staining obtained from a previous pathological evaluation or 2) are scheduled for a procedure to obtain tissue for pathological evaluation that can be fixed and paraffin embedded for immunohistochemical staining are eligible for this study. The ovarian mass may be either an initial finding, e.g., found at a routine pelvic examination or to investigate symptoms, or the ovarian or endometrial mass may be a finding suspicious of recurrent or residual tumor at follow-up examination after surgical resection of confirmed ovarian or endometrial cancer. Patients may not be pregnant or breastfeeding at enrollment.

Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Women With Suspected Ovarian or Endometrial Cancer

A Multi-center Clinical Study to Evaluate the Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Women With Suspected Ovarian or Endometrial Cancer

Symptoms and General Pathology

Digestive System Diseases

Recurrence

Pancreatic Neoplasms

Head and Neck Neoplasms

Neoplasm Metastasis

Urinary Bladder Neoplasms

Testicular Neoplasms

Neoplasms, Second Primary

Disease Attributes

Urologic Neoplasms

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Neoplastic Processes

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Genital Neoplasms, Male

Genital Diseases, Male

Testicular Diseases

Pancreatic Cancer

Gastrointestinal Agents

Pancrelipase

Pancreatin

Nelson M Oyesiku, MD, PhD

The folate receptor is over-expressed on many types of cancer cells and new folate receptor targeted therapies are being developed to target cancer cells that over-express the folate receptor. As with other targeted therapies, it is important to develop diagnostic tests that will provide accurate information on folate receptor status and aid in selecting patients that may benefit from folate-targeted therapy.

This Phase II, limited institution, open-label, single-arm, baseline-controlled study is designed to obtain data on the percentage of patients with recurrent or metastatic cancer from a solid tumor (including, but not limited to, breast, lung, mesothelioma, liver, colorectal, prostate, head and neck, pancreas, bladder and testicular cancer) with increased uptake of FalateScan in tumors, correlate the immunohistochemical staining findings with the FolateScan images, and verify product safety in patients with suspected recurrent or metastatic disease from any solid tumor.

Safety and Efficacy of FalateScan (Technetium Tc 99m EC20) in Patients With Known Suspected Recurrent or Metastatic Cancer From a Solid Tumor

A Phase II Clinical Study to Evaluate the Safety and Efficacy of FalateScan (Technetium Tc 99m EC20) in Patients With Known Suspected Recurrent or Metastatic Cancer From a Solid Tumor

Carcinoma, Renal Cell

Adenocarcinoma

Kidney Neoplasms

Kidney Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Subjects will receive two intravenous injections 1-3 minutes apart:

1. 1 mg of folic acid
2. 1-2 mL injection of 0.1 mg of EC20 labeled with 15-25 mCi of technetium-99m

The folate receptor (FR) is overexpressed by many different cancer types, including renal cell carcinoma. Besides helping in the diagnosis of cancer, a folate-targeted imaging agent could provide an effective method to identify folate receptor-positive (FR+) cancer patients that may benefit from folate-targeted therapy. Up to 40 subjects, with known or strongly suspected metastatic renal cell carcinoma with at least one target lesion detected by a diagnostic imaging procedure (e.g. ultrasonography, CT, or MRI), will be enrolled in this study.

The investigational new drug (FolateScan or Technetium Tc 99m EC20) is a folate-targeted diagnostic radiopharmaceutical 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.

Endocyte's folate-targeted delivery system was applied towards the targeting of a diagnostic imaging agent (111In-DTPA-Folate) to ovarian cancer tumors. This proof-of-principle study was designed to demonstrate the ability of folate to target drugs to folate-receptor-positive (FR+) cancer tissue.

Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Subjects With Suspected Metastatic Renal Cell Carcinoma

A Multi-center Clinical Study to Evaluate the Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Subjects With Suspected Metastatic Renal Cell Carcinoma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Biodistribution of Technetium Tc 99m EC20 in Normal Volunteers and Ovarian Cancer Patients	NCT01689636	Ovarian Cancer Healthy Volunte...	Tc 99m EC20	18 Years -	Endocyte
Safety and Biodistribution of Technetium Tc 99m EC20 in Normal Volunteers and Ovarian Cancer Patients	NCT01689636	Ovarian Cancer Healthy Volunte...	Tc 99m EC20	18 Years -	Endocyte
Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Women With Suspected Ovarian or Endometrial Cancer	NCT01686256	Ovarian Cancer Endometrial Can...	Tc 99m EC20	18 Years -	Endocyte
Safety and Efficacy of FalateScan (Technetium Tc 99m EC20) in Patients With Known Suspected Recurrent or Metastatic Cancer From a Solid Tumor	NCT01684098	Recurrent or Me... Head and Neck C... Pancreas Cancer Bladder Cancer Testicular Canc...	Tc 99m EC20	18 Years -	Endocyte
Safety and Efficacy of FalateScan (Technetium Tc 99m EC20) in Patients With Known Suspected Recurrent or Metastatic Cancer From a Solid Tumor	NCT01684098	Recurrent or Me... Head and Neck C... Pancreas Cancer Bladder Cancer Testicular Canc...	Tc 99m EC20	18 Years -	Endocyte
Safety and Efficacy of FolateScan (Technetium Tc 99m EC20) in Subjects With Suspected Metastatic Renal Cell Carcinoma	NCT01689662	Metastatic Rena...	Tc 99m EC20	18 Years -	Endocyte

Spots Global Cancer Trial Database for tc 99m ec20

Every month we try and update this database with for tc 99m ec20 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tc 99m ec20

Every month we try and update this database with for tc 99m ec20 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tc 99m ec20 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.