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Protocol No. UW17034

Principal Investigator Fowler, Amy

Phase II

Age Group Adult

Scope Local

Sponsor Type Institutional

Title [18F]Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging of Progesterone Receptor Expression in Invasive Breast Cancer

Objective Treatment decisions for breast cancer often depend on certain characteristics identified about the cancer such as progesterone receptor (PR) status. Currently, these characteristics are determined after tumor tissue has been biopsied or removed and tested in a laboratory. The purpose of this research is to learn more about a new tracer called fluorofuranylnorprogesterone (FFNP) for PET/MR and PET/CT scans. We want to find out if FFNP can show whether breast cancers are progesterone receptor positive or negative. This information could help doctors in the future determine which treatment would be most effective.

Treatment PET, or positron emission tomography, takes pictures of inside your body by using a radioactive tracer that is injected through a needle in your arm. The FFNP solution is a radioactive tracer that will travel through your entire body. PET images are made when the scanner detects where the radioactive tracer travels in the body. CT scans take 3-dimensional pictures of inside the body using x-rays. Currently, PET and CT images are collected at the same time because the CT scan will provide clear images of the body's anatomy and the PET scan will show where in the body the tracer is more concentrated. MRI scans use a combination of radio waves and a large magnet to get very detailed images of inside the body. This research will be collecting PET and MRI images with FFNP to see if these images provide information that is currently only obtained after a biopsy.

Description When you arrive at the Wisconsin Institutes for Medical Research (WIMR), an IV will be placed in a vein in your arm. Then we will inject the PET tracer (FFNP) into the IV line. You will need to sit quietly for 60 minutes while the tracer circulates through your body. You will then lie on your stomach in the PET/CT scanner and images will be collected over approximately 20 minutes. Once the PET/CT is complete, you will be moved to the PET/MRI scanner. You will again lie on your stomach and images will take approximately 30 to 40 minutes to collect. Five of the 28 subjects that participate in this research will be asked to come back for a second repeat study visit. This will allow us to compare two images from two different time points to ensure the results of images with FFNP.

Key Eligibility
  • Women 18 years of age or older
  • Diagnosis of biopsy-proven invasive breast cancer measuring at least 1.5 cm in diameter by any imaging modality Biopsy-proven PR-positive (N=23) or PR-negative (N=5) invasive breast cancer, as defined by University of Wisconsin (UW) Health Pathology
  • Undergoing diagnostic breast MRI ordered by the referring clinician for staging and extent of disease
  • Patients planning to receive neoadjuvant chemotherapy/endocrine therapy after the clinical breast MRI and before the research breast PET/MRI examination, those currently undergoing neoadjuvant chemotherapy/endocrine therapy, or those who have received chemotherapy/endocrine therapy within 6 months prior to the MRI are ineligible
  • Patients taking hormone replacement therapy or oral contraceptives during the 6 weeks prior to the MRI are ineligible
  • Patients who have had surgical intervention or radiation for the current biopsy-proven malignancy are ineligible
  • Patients with breast implants or expanders are ineligible
  • Patients who are or might be pregnant or lactating are ineligible
  • Patients in liver failure as judged by the patient's physician are ineligible
  • Each patient can only enroll once within the time period of the study

Applicable Disease Sites Breast

Status Open

Participating Institutions UW Hospital and Clinics; UWCCC 1 South Park