Study of 18F-FFNP Breast PET/MRI
Eligible age
18+ yrs
Accepts
Women
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
This clinical trial will investigate an estrogen-regulated parameter as an early measure of endocrine therapy response: progesterone receptor (PR) protein with a progestin-based radioligand, 18F-fluorofuranylnorprogesterone (18F-FFNP). The overall purpose of this research is to test the efficacy of 18F-FFNP PET/MRI for predicting response to presurgical endocrine therapy and to determine the quantitative reliability of 18F-FFNP breast PET/MRI in patients with newly diagnosed PR+ primary breast cancer.
Sponsor: University of Wisconsin, Madison
You may qualify if…
- ✓ Postmenopausal status defined by either
- ✓ prior bilateral oophorectomy
- ✓ age greater than or equal to 60 years of age
- ✓ age less than 60 years of age and amenorrheic for 12 or more months in the absence of prior chemotherapy, tamoxifen, toremifene or ovarian suppression and FSH and estradiol in the postmenopausal range per local normal range (Group 2 only)
- ✓ Diagnosis of biopsy-proven invasive breast cancer measuring at least 1.0 cm in diameter by any imaging modality. Malignancy may be located within the breast, axilla (e.g. metastatic axillary lymph node), or both the breast and axilla
- ✓ Biopsy-proven PR-positive invasive breast cancer
- ✓ Definitive surgical excision of the primary tumor planned without neoadjuvant therapy; defined as therapy (chemotherapy, targeted therapy, radiation therapy or endocrine therapy) given to decrease the size of the tumor prior to planned surgery. (Group 2 only)
You may not qualify if…
- ✕ Inability or unwillingness to provide informed consent to the study
- ✕ HER2-positive breast cancer, as defined by immunohistochemical staining 3+ OR positive by in situ hybridization (Group 2 only)
- ✕ PR and Ki67 IHC slides or FFPE tissue blocks from clinical breast biopsy not available
- ✕ Patients who have completed neoadjuvant chemotherapy, endocrine therapy, targeted therapy, surgical resection, or radiation for the current biopsy-proven malignancy (Group 2 only)
- ✕ Patients who are planning to undergo anastrozole as standard of care neoadjuvant therapy
- ✕ Patients who are currently taking aromatase inhibitors or ER antagonists (tamoxifen, raloxifene)
- ✕ Patients with breast expanders
- ✕ Patients who are pregnant or lactating
Where it's recruiting
Madison
Source: ClinicalTrials.gov · NCT06086704 · last updated 2026-05-18