NCT06086704

Study of 18F-FFNP Breast PET/MRI

Phase II Study of 18F-FFNP Breast PET/MRI in the Assessment of Early Response of Breast Cancer to Presurgical Endocrine Therapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objective • Determine the diagnostic accuracy of 18F-FFNP PET/MRI for predicting response to presurgical endocrine therapy. Secondary Objectives * Determine the repeatability of quantitative assessment of tumor 18F-FFNP uptake. * Determine the intra- and inter-observer variability of quantitative assessment of tumor 18F-FFNP uptake. * Assess the safety and tolerability of 18F-FFNP. Exploratory Objectives * Define the parent and metabolite fractions of 18F-FFNP over the time course of the scan. * Assess the association between tumor 18F-FFNP uptake with serum progesterone, estradiol, and corticosteroid binding globulin levels. * Compare changes in 18F-FFNP breast PET/MRI parameters with changes in PR immunohistochemistry in therapy responders and non-responders. * Assess the association between tumor 18F-FFNP uptake with disease recurrence. * Determine whether MRI parameters improve the predictive value of FFNP PET alone.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-09-25
• Primary completion: 2027-01-01
• Completion: 2030-01-01
• First posted: 2023-10-17
• Last updated: 2025-10-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study