NCT06086704 · University of Wisconsin, Madison
Study of 18F-FFNP Breast PET/MRI
What this study is about
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).
View original scientific description
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.
Interventions
DRUG
18F-fluorofuranylnorprogesterone
18F-FFNP will be given by a slow infusion (approximately 2 minutes), and the dose administered will be approximately 7 mCi.
DEVICE
Positron Emissions Tomography / Magnetic Resonance Imaging
Breast specific PET/MRI data will be acquired using a 3T simultaneous PET/MRI scanner (Signa PET/MR, GE Healthcare)
DRUG
Anastrozole
hormone based chemotherapy that reduces estrogen, 1 mg anastrozole once daily by mouth for a minimum of 14 days
OTHER
Blood Sampling
Venous blood samples will be collected at multiple timepoints (e.g., 5, 10, 20, 30, and 45 min after 18F-FFNP injection to determine parent and metabolite fractions
DRUG
FDA-approved gadolinium-based intravenous contrast agent
FDA-approved gadolinium-based intravenous contrast agent used for the MRI portion of this study
Primary outcome measures
Percentage change in 18F-FFNP uptake between baseline and follow-up PET/MRI scans
Time frame: up to 4 weeks on study and up to 7 weeks on study
Tumor uptake values of 18F-FFNP will be obtained from the attenuation corrected PET component of the simultaneous breast 18F-FFNP PET/MRI research scan according to the procedures detailed in the imaging manual and the FDA IND.
Percentage change in tumor Ki67 proliferation score, as a surrogate measure of endocrine sensitivity
Time frame: up to 4 weeks on study and up to 7 weeks on study
Baseline Ki67 proliferation immunohistochemistry score will be obtained from the existing clinical standard-of-care breast biopsy. Post-treatment K67 proliferation immunohistochemistry score will be obtained from the surgical specimen after excision. Treatment response is defined as a reduction in Ki67 score of greater than or equal to 60 percent. Treatment nonresponse is defined as a reduction of less than 60 percent.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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)
Exclusion criteria
- 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
- Patients with clinical contraindication for use of aromatase inhibitors (AI) while on study as determined by investigator (Group 2 only)
- Patients with a contraindication to gadolinium-based contrast agents, including allergy or impaired renal function (per UW Health Guidelines)
- Patients with a history of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-FFNP
- Patients with history of allergic reaction to anastrozole (Group 2 only)
- Patients in liver failure as judged by the patient's physician
- Patients with standard contraindications to MRI (per UW Health Guidelines)
- Patients requiring conscious sedation for imaging are not eligible; patients requiring mild, oral anxiolytics for the clinical MRI scan will be allowed to participate as long as the following criteria are met:
- The patient has their own prescription for the medication
- The informed consent process is conducted prior to the self-administration of the medication.
- The patient comes to the research visit with a driver.
- Patients unable to lie prone for 45 minutes for imaging
Where
- Madison, Wisconsin
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 18, 2026 · Source of record for eligibility and locations