Study of 18F-FFNP Breast PET/MRI

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT06086704
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 18F-fluorofuranylnorprogesterone — DRUG
    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 — DEVICE
    Breast specific PET/MRI data will be acquired using a 3T simultaneous PET/MRI scanner (Signa PET/MR, GE Healthcare)
  • Anastrozole — DRUG
    hormone based chemotherapy that reduces estrogen, 1 mg anastrozole once daily by mouth for a minimum of 14 days
  • Blood Sampling — OTHER
    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 — DRUG
    FDA-approved gadolinium-based intravenous contrast agent used for the MRI portion of this study

Study Details

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.

Key Dates

Start date
Sep 25, 2024
Status verified
May 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2030

Study Design

Enrollment
53 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

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

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UW Carbone Cancer CenterMadisonWisconsin53792
Roberta M Strigel, MD, MS (SUB_INVESTIGATOR)
Kari B Wisinski, MD (SUB_INVESTIGATOR)
Lee G Wilke, MD (SUB_INVESTIGATOR)
Scott B Perlman, MD (SUB_INVESTIGATOR)
Lonie R Salkowski, MD, MS, PhD (SUB_INVESTIGATOR)
Aparna M Mahajan, MD (SUB_INVESTIGATOR)
Stephanie M McGregor, MD, PhD (SUB_INVESTIGATOR)
Emmanuel Sampene, PhD (SUB_INVESTIGATOR)

Find similar trials in Madison, WI

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
UW Carbone Cancer Center· Madison, WI

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