Status:
COMPLETED
Assessment of Progesterone Receptors in Breast Carcinoma by Positron Emission Tomography (PET) Using Fluoro Furanyl Norprogesterone (FFNP)
Lead Sponsor:
Washington University School of Medicine
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to see if Positron Emission Tomography (PET) imaging with a radioactive form of the hormone progesterone called FFNP will give the same results as hormone receptor testing...
Eligibility Criteria
Inclusion
- Female patients 18 years of age or older
- Biopsy-proven breast cancer
- Tumor estrogen-receptor and progesterone-receptor status already determined or scheduled to be determined at time of surgery without intervening therapy.
- Primary lesion size ≥ 1.5 cm as determined by imaging studies (ultrasonography, mammography, CT or MRI) or physical examination
- Able to give informed consent
- Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and / or documented hysterectomy), post menopausal (cessation of menses for more than 1 year), non lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of FFNP) is negative.
Exclusion
- No previous history of hormone therapy; NOTE - subjects who were treated with hormone therapy for reasons other than breast cancer or breast cancer prevention may be allowed to participate after review of history by the primary investigator
- Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years
- Unable to tolerate 60-90 minutes of PET imaging per imaging session
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00968409
Start Date
January 1 2007
End Date
January 1 2011
Last Update
December 9 2015
Active Locations (1)
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1
Washington University / Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110