Safety and Biodistribution of Technetium Tc 99m EC20 in Normal Volunteers and Ovarian Cancer Patients
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ClinicalTrials.gov Identifier: NCT01689636 |
Recruitment Status
:
Completed
First Posted
: September 21, 2012
Last Update Posted
: September 21, 2012
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ovarian Cancer Healthy Volunteers | Drug: Tc 99m EC20 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Official Title: | 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 |
Study Start Date : | August 2000 |
Actual Study Completion Date : | July 2002 |

Arm | Intervention/treatment |
---|---|
Experimental: Single-center, open-label
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. |
Drug: Tc 99m EC20 |
- Determine the biodistribution and excretion of the radioactive drug substance (Technetium Tc 99m EC20) and estimate the radiation absorbed dose [ Time Frame: 24 hours ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
-
All subjects were to be females 18 years of age or older who met the following criteria:
- The four normal subjects were to be normal, as established by medical history, physical examination, and laboratory data, including CBC, serum chemistry, and urinalysis.
- The two subjects with obvious advanced stage ovarian cancer were to have either histopathologically proven stage 3 or 4 disease or clinically obvious disease defined by 2 of the following 3 conditions: (1) pelvic mass (2) omental "caking", or (3) ascites.
- Subjects were to have newly diagnosed, treatment refractory, or recurrent disease. Subjects were to be treatment naïve or at least 2 months since last non-surgical treatment. Subjects were to have normal kidney and liver function.
- The two subjects with suspected ovarian cancer were to have a known mass. Subjects were to have normal kidney and liver function.
- Subjects were to provide informed consent prior to enrollment.
Exclusion Criteria:
-
The following subjects were to be excluded:
- Subject was pregnant or breast-feeding.
- Subject was simultaneously participating in another investigative drug or device study, or had completed follow-up phase of any previous study within 30 days prior to enrollment in this study.
- Subject had a known history of chronic abuse of drugs or alcohol or had tested positive in the pre-study urine drug abuse screen.
- Subject was currently taking folic acid supplements and could not stop taking the supplements for a period of 3 days (2 days prior to the study and one day after last imaging procedure).
- Subject had physical condition that was unsuitable for radionuclide imaging.
- Subject had been administered another radiopharmaceutical that would interfere with the assessment of the biodistribution of Technetium Tc 99m EC20.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01689636
United States, Missouri | |
Washington University Medical Center | |
St. Louis, Missouri, United States |
Responsible Party: | Endocyte |
ClinicalTrials.gov Identifier: | NCT01689636 History of Changes |
Other Study ID Numbers: |
EC20.1 |
First Posted: | September 21, 2012 Key Record Dates |
Last Update Posted: | September 21, 2012 |
Last Verified: | September 2012 |
Keywords provided by Endocyte:
Ovarian Cancer |
Additional relevant MeSH terms:
Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female |
Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Technetium Tc 99m-ethylenedicysteine Radiopharmaceuticals Molecular Mechanisms of Pharmacological Action |