Recruiting
Phase 2

18F-FFNP

Sponsor:

University of Wisconsin, Madison

Code:

NCT06086704

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

18F-fluorofuranylnorprogesterone

Positron Emissions Tomography / Magnetic Resonance Imaging

Anastrozole

Blood Sampling

FDA-approved gadolinium-based intravenous contrast agent

Study Details

Brief summary:

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.

Conditions

Breast Cancer

Study ID

NCT06086704

Start date

Sep 25, 2024

Status verified date

Aug, 2026

Completion date

Aug 31, 2030

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

53 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Group 1: Metabolite Analysis

participants will undergo venous blood sampling during the PET/MRI scan

experimental: Group 2: Pre-surgical Treatment

participants will undergo PET/MRI scans before and after 2 weeks treatment with anastrozole

experimental: Group 3: Test-Retest

participants will undergo baseline and repeat PET/MRI scans without intervening treatment to determine repeatability

Interventions

18F-fluorofuranylnorprogesterone

18F-FFNP will be given by a slow infusion (approximately 2 minutes), and the dose administered will be approximately 7 mCi.

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)

Anastrozole

hormone based chemotherapy that reduces estrogen, 1 mg anastrozole once daily by mouth for a minimum of 14 days

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

FDA-approved gadolinium-based intravenous contrast agent

FDA-approved gadolinium-based intravenous contrast agent used for the MRI portion of this study

Primary outcome measure

  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Cancer Connect

800-622-8922clinicaltrials@cancer.wisc.edu

Locations

UW Carbone Cancer Center

Recruiting

Madison, Wisconsin, United States, 53792

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Keywords

  • PR+

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-08-31.