FFNP-PET/MR Imaging of Progesterone Receptor Expression in Invasive Breast Cancer (NCT03212170) | Clinical Trial Compass
CompletedPhase 2
FFNP-PET/MR Imaging of Progesterone Receptor Expression in Invasive Breast Cancer
United States21 participantsStarted 2017-12-13
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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 …
What they're measuring
1
Correlation Coefficient Between FFNP Uptake and Allred Score