RecruitingPhase 2NCT06086704

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

Sponsor

University of Wisconsin, Madison

Enrollment

53 participants

Start Date

Sep 25, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a specialized PET/MRI scan using a radioactive tracer called 18F-FFNP to see if it can predict how well breast cancer will respond to hormone-blocking treatments. The scan measures progesterone receptor activity in tumors, which may help guide treatment decisions before surgery. **You may be eligible if...** - You are postmenopausal (either by age 60+, prior removal of ovaries, or confirmed hormone levels) - You have been diagnosed with invasive breast cancer that is progesterone receptor-positive (PR+), confirmed by biopsy - Your tumor is at least 1 cm in size - You are planning to have surgery without receiving neoadjuvant (pre-surgery) therapy first - A breast MRI has been or will be performed before surgery **You may NOT be eligible if...** - Your cancer is HER2-positive - You are planning or receiving chemotherapy, targeted therapy, or radiation before surgery - You have a strong allergy to the imaging agents used - You are unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG18F-fluorofuranylnorprogesterone

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

DEVICEPositron 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)

DRUGAnastrozole

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

OTHERBlood 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

DRUGFDA-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

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