Phase II Study of 18F-FFNP Breast PET/MRI in the Assessment of Early Response of Breast Cancer to Presurgical Endocrine Therapy
University of Wisconsin, Madison
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.
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, estradio…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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 * Biopsy-proven PR-positive invasive breast cancer * Breast MRI planned or performed before surge…
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
Location
- UW Carbone Cancer CenterMadison, Wisconsin