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

Study Overview
=================
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.

Official Title
-----------------
Labeling of Receptor Ligands and Other Compounds With Halogen Radionuclides: Assessment of Progesterone Receptors in Breast Carcinoma by Positron Emission Tomography (PET) Using FFNP

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Radiation: PET
* Other: Laboratory Testing
* Other: Safety Testing
* Drug: F18-FFNP


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: FFNP-PET/CT Imaging<br>All subjects will receive an injection of F-18-FFNP followed by PET/CT imaging, laboratory testing and safety testing. | Radiation: PET<br>* PET imaging following injection of F18-FFNP to image hormone receptor status in patients with newly diagnosed breast cancer<br>Other: Laboratory Testing<br>* Blood and urine samples for standard laboratory testing and radioactive counts will be obtained during the imaging sessions. Testing will include: urinalysis, complete blood count, comprehensive metabolic panel, and progesterone levels<br>Other: Safety Testing<br>* ECG tracings and vital signs (blood pressure, heart rate, body temperature and respiration rate) are obtained at several time points before, during and after the imaging sessions.<br>Drug: F18-FFNP<br>* injection of F18-FFNP<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of FFNP-PET imaging compared to in-vivo receptor status |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| To calculate human dosimetry and overall safety of FFNP-PET imaging |  | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer, Hormone Receptor