Phase 2
Completed N=21
FFNP-PET/MR Imaging of Progesterone Receptor Expression in Invasive Breast Cancer
Invasive Breast Cancer
Source: ClinicalTrials.gov NCT03212170 ↗
Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcomePrimary: Correlation Coefficient Between FFNP Uptake and Allred Score — 0.3215 correlation coefficient (rho) — p=0.1347
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Correlation Coefficient Between FFNP Uptake and Allred Score |
0.3215 | 0.1347 |
| SECONDARY Test-Retest Reproducibility |
NA; NA | — |
| SECONDARY Intra and Inter-Observer Assessment |
2.76; 2.629 | — |
| SECONDARY Correlation Coefficient Between Tumor FFNP Uptake With Oncotype DX Score |
-0.377 | 0.2521 |
| SECONDARY Distinguishing Between PR Negative and PR Positive Breast Cancer Reported as Area Under the Curve (AUC) |
0.80; 0.70 | — |
| SECONDARY Distinguishing Between PR Negative and PR Positive Breast Cancer Reported as Optimal Cut Point |
1.96; 1.96 | — |
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
Data sourced from ClinicalTrials.gov (NCT03212170). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.