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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


Phase 1
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer, Healthy Volunteers

Thank you

Trial Information

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


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.


Inclusion Criteria:



- All subjects were to be females 18 years of age or older who met the following
criteria:

1. The four normal subjects were to be normal, as established by medical history,
physical examination, and laboratory data, including CBC, serum chemistry, and
urinalysis.

2. 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.

3. 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.

4. The two subjects with suspected ovarian cancer were to have a known mass.
Subjects were to have normal kidney and liver function.

5. Subjects were to provide informed consent prior to enrollment.

Exclusion Criteria:

- The following subjects were to be excluded:

1. Subject was pregnant or breast-feeding.

2. 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.

3. Subject had a known history of chronic abuse of drugs or alcohol or had tested
positive in the pre-study urine drug abuse screen.

4. 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).

5. Subject had physical condition that was unsuitable for radionuclide imaging.

6. Subject had been administered another radiopharmaceutical that would interfere
with the assessment of the biodistribution of Technetium Tc 99m EC20.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Determine the biodistribution and excretion of the radioactive drug substance (Technetium Tc 99m EC20) and estimate the radiation absorbed dose

Outcome Time Frame:

24 hours

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

EC20.1

NCT ID:

NCT01689636

Start Date:

August 2000

Completion Date:

July 2002

Related Keywords:

  • Ovarian Cancer
  • Healthy Volunteers
  • Ovarian Cancer
  • Ovarian Neoplasms

Name

Location

Washington University Medical CenterSaint Louis, Missouri  63105