Assessment of Progesterone Receptors in Breast Carcinoma by Positron Emission Tomography (PET) Using Fluoro Furanyl Norprogesterone (FFNP)

Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: Radiation: PET; Other: Laboratory Testing; Other: Safety Testing; Drug: F18-FFNP

• Registration Number: NCT00968409
• Lead Sponsor: Washington University School of Medicine

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 already performed on tissue used to diagnose breast cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2009-08-28
• Study First Submitted QC: 2009-08-28
• Study First Posted: 2009-08-31
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-07
• Last Update Posted: 2015-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FFNP-PET/CT Imaging	Safety Testing	All subjects will receive an injection of F-18-FFNP followed by PET/CT imaging, laboratory testing and safety testing.
FFNP-PET/CT Imaging	Laboratory Testing	All subjects will receive an injection of F-18-FFNP followed by PET/CT imaging, laboratory testing and safety testing.
FFNP-PET/CT Imaging	F18-FFNP	All subjects will receive an injection of F-18-FFNP followed by PET/CT imaging, laboratory testing and safety testing.
FFNP-PET/CT Imaging	PET	All subjects will receive an injection of F-18-FFNP followed by PET/CT imaging, laboratory testing and safety testing.

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of FFNP-PET imaging compared to in-vivo receptor status	4 years

Secondary Outcome Measures

Name	Time	Method
To calculate human dosimetry and overall safety of FFNP-PET imaging	4 years
To assess the diagnostic quality of FFNP-PET images at the proposed 10.0 mCi dose	4 years
To determine the relationship between tumor FFNP uptake and in vitro status of progesterone receptor	4 years

Trial Locations

Locations (1)

Washington University / Barnes-Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States