FFNP-PET/MR Imaging of Progesterone Receptor Expression in Invasive Breast Cancer



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/14/2018
Start Date:July 15, 2017
End Date:January 1, 2020
Contact:Gemma Gliori, MS
Email:ggliori@uwhealth.org
Phone:608-262-7269

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

The goal of this research is to test the accuracy of PET/MRI imaging with
18F-fluorofuranylnorprogesterone (FFNP) for measuring progesterone receptor (PR) expression
in patients with invasive breast cancer. We hypothesize that FFNP SUVmax from PET/MRI will
correlate well against the semi-quantitative PR immunohistochemistry score.

Integrated whole-body magnetic resonance imaging (MRI)-positron emission tomography (PET)
scanners have recently been introduced for clinical use. This technology combines the
anatomic and perfusion data obtained with dynamic contrast enhanced (DCE) MRI with functional
imaging data obtained from PET. For breast imaging, the combination of MRI and PET has
important potential to improve diagnostic accuracy and provide molecular characterization of
breast cancer. The overall purpose of this research is to test the accuracy of PET/MRI
imaging with 18F-fluorofuranylnorprogesterone (FFNP) for measuring progesterone receptor (PR)
expression in patients with invasive breast cancer.

This is a prospective, one-arm, observational study which will enroll patients with newly
diagnosed breast cancer scheduled for diagnostic breast MRI for preoperative staging/extent
of disease evaluation as part of standard of care. Participation in this research study
includes a directed breast PET/MRI with the investigational radiopharmaceutical, FFNP. For
patients who are willing and if there is scanner time available, an optional research breast
PET/CT exam will be performed before the PET/MRI exam. FFNP uptake of the known,
biopsy-proven malignancy will be measured on the PET/MRI and PET/CT examinations using
standardized uptake values (SUV) and tumor-to-normal tissue ratios.

Inclusion Criteria:

- Women 18 years of age or older

- Diagnosis of biopsy-proven invasive breast cancer measuring at least 1.0 cm in
diameter by any imaging modality

- Biopsy-proven PR-positive (N=23) or PR-negative (N=5) invasive breast cancer

- Undergoing diagnostic breast MRI ordered by the referring clinician for staging and
extent of disease

Exclusion Criteria:

- Inability or unwillingness to provide informed consent to the study

- Patients currently undergoing neoadjuvant chemotherapy/endocrine therapy, or those who
have received chemotherapy/endocrine therapy within 6 months prior to the MRI

- Patients taking hormone replacement therapy or oral contraceptives during the 6 weeks
prior to the MRI

- Patients who have had neoadjuvant chemotherapy/endocrine therapy, surgical
intervention or radiation for the current biopsy-proven malignancy

- Patients with breast expanders

- Patients who are or might be pregnant or lactating

- Patient girth exceeds the bore of the PET/MRI scanner

- Patients with a contraindication to gadolinium based contrast agents, including
allergy or impaired renal function (per University of Wisconsin Health Guidelines)

- Patients with a history of allergic reaction attributable to compounds of similar
chemical or biologic composition to FFNP

- Patients in liver failure as judged by the patient's physician

- Patients with standard contraindications to MRI, including claustrophobia and metallic
implants incompatible with MRI

- Patients requiring conscious sedation for imaging

- Patients unable to lie prone for 30 minutes for imaging

- Each patient can only enroll once within the time period of the study
We found this trial at
1
site
Madison, Wisconsin 53706
(608) 263-2400
Principal Investigator: Amy Fowler, MD, PhD
Phone: 608-262-7269
University of Wisconsin-Madison In achievement and prestige, the University of Wisconsin-Madison has long been recognized...
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