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A MULTI-CENTER CLINICAL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF FOLATESCAN (TECHNETIUM Tc 99m EC20) IN PATIENTS WITH SUSPECTED OVARIAN CARCINOMA OR RECURRENT ENDOMETRIAL CARCINOMA


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Carcinoma, Recurrent Endometrial Carcinoma

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Trial Information

A MULTI-CENTER CLINICAL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF FOLATESCAN (TECHNETIUM Tc 99m EC20) IN PATIENTS WITH SUSPECTED OVARIAN CARCINOMA OR RECURRENT ENDOMETRIAL CARCINOMA


This phase 2, two-center, open-label, single-treatment group, within-patient-controlled
study was conducted to:

- Expand the safety database and gather data on the percentage of patients with known or
suspected ovarian carcinoma or recurrent endometrial carcinoma who show increased
uptake of FolateScan in tumors (primary objective).

- Calculate the sensitivity, specificity, accuracy, positive predictive value, and
negative predictive value of FolateScan compared with immunohistochemical (IHC)
staining (secondary objective).


Inclusion Criteria:



- Subjects must meet the following eligibility requirements to be enrolled in the
study.

1. Subject must be 18 years of age or older.

2. Subject must have known or strongly suspected ovarian carcinoma or recurrent
endometrial carcinoma with at least one identifiable lesion > 1.5 cm as
diagnosed by ultrasonography, MRI, or CT.

3. Subject must have good kidney function.

4. Subject must provide written informed consent prior to enrollment.

Exclusion Criteria:

- Subjects must be excluded if any of the following conditions are present:

1. Subject is pregnant or breastfeeding.

2. Subject is simultaneously participating in another investigational drug study.

3. Subject has completed the follow-up phase of any previous study less than 30
days prior to enrollment in this study.

4. Subject is unable to tolerate conditions for radionuclide imaging.

5. Subject has been administered another radiopharmaceutical that would interfere
with the assessment of Technetium Tc 99m EC20.

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Val J Lowe, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

EC20.4

NCT ID:

NCT01689714

Start Date:

August 2003

Completion Date:

August 2005

Related Keywords:

  • Ovarian Carcinoma
  • Recurrent Endometrial Carcinoma
  • Ovarian Carcinoma
  • Recurrent Endometrial Carcinoma
  • Carcinoma
  • Ovarian Neoplasms
  • Neoplasms, Glandular and Epithelial
  • Adenoma
  • Endometrial Neoplasms

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