Clinical trial NCT03212170: FFNP-PET/MR Imaging of Progesterone Receptor Expression in Invasive Breast Cancer
Official title: [18F]Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging of Progesterone Receptor Expression in Invasive Breast Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Invasive Breast Cancer
Keywords: Invasive Breast Cancer
Metastatic Breast Cancer
PR Positive Breast Cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2017-07-11
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: DIAGNOSTIC

Brief summary: 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. The hypothesis is that FFNP SUVmax from PET/MRI will correlate well against the semi-quantitative PR immunohistochemistry score.

Detailed description: 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, 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. FFNP uptake of the known, biopsy-proven malignancy will be measured on the PET/MRI examinations using standardized uptake values (SUV) and tumor-to-normal tissue ratios.

Eligibility criteria: 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 or PR-negative 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
* Participants currently undergoing neoadjuvant chemotherapy/endocrine therapy or those who have received chemotherapy/endocrine therapy within 6 months prior to the MRI
* Participants who have had neoadjuvant chemotherapy/endocrine therapy, surgical intervention, or radiation for the current biopsy-proven malignancy
* Participants with breast expanders
* Participants who are or might be pregnant or lactating
* Participants with a contraindication to gadolinium based contrast agents, including allergy or impaired renal function (per University of Wisconsin Health Guidelines)
* Participants with a history of allergic reaction attributable to compounds of similar chemical or biologic composition to FFNP
* Participants in liver failure as judged by the patient's physician
* Participants with standard contraindications to MRI, including claustrophobia and metallic implants incompatible with MRI
* Participants requiring intravenous (IV) conscious sedation for imaging are not eligible; participants requiring mild, oral anxiolytics for the clinical MRI will be allowed to participate as long as the following criteria are met:

  * The subject has their own prescription for the medication
  * The informed consent process is conducted prior to the self-administration of this medication
  * They come to the research visit with a driver
* Participants unable to lie prone for 30 minutes for imaging

Primary outcomes:
measure: FFNP Uptake
timeFrame: Up to 1 day
Secondary outcomes:
measure: Test-Retest Reproducibility
timeFrame: Up to 4 weeks
measure: Intra and Inter-Observer Assessment
timeFrame: Up to 4 weeks
measure: Association of tumor FFNP uptake with Oncotype DX score
timeFrame: Up to 4 weeks
measure: Distinguishing between PR Negative and PR Positive Breast Cancer
timeFrame: up to 4 weeks
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin, Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Amy Fowler, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: