FFNP-PET/MR Imaging of Progesterone Receptor Expression in Invasive Breast Cancer
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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 (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
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
- Participant girth exceeds the bore of the PET/MRI scanner
- 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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Invasive Breast Cancer
Age (in years)
18+
Phase
Phase 2
Participants needed
21
Est. Completion Date
Dec 31, 2024
Treatment type
Interventional
Sponsor
University of Wisconsin, Madison
ClinicalTrials.gov identifier
NCT03212170
Study number
20170533
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