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RECRUITING
NCT06086704
PHASE2

Study of 18F-FFNP Breast PET/MRI

Sponsor: University of Wisconsin, Madison

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

53

Start Date

2024-09-25

Completion Date

2030-01

Last Updated

2025-10-01

Healthy Volunteers

No

Conditions

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

Locations (1)

UW Carbone Cancer Center

Madison, Wisconsin, United States