Study of 18F-FFNP Breast PET/MRI

NCT06086704 | Recruiting Phase 2 FDA Drug

• 5 other identifiers: 2023-1114Protocol Version 7/30/2024SMPH/RADIOLOGY/RADIOLOGYUW230201R01CA272571-01
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

PR+

Outcome Measures

Primary Outcomes (2)

• Percentage change in 18F-FFNP uptake between baseline and follow-up PET/MRI scans

  Tumor uptake values of 18F-FFNP will be obtained from the attenuation corrected PET component of the simultaneous breast 18F-FFNP PET/MRI research scan according to the procedures detailed in the imaging manual and the FDA IND.

  up to 4 weeks on study and up to 7 weeks on study

• Percentage change in tumor Ki67 proliferation score, as a surrogate measure of endocrine sensitivity

  Baseline Ki67 proliferation immunohistochemistry score will be obtained from the existing clinical standard-of-care breast biopsy. Post-treatment K67 proliferation immunohistochemistry score will be obtained from the surgical specimen after excision. Treatment response is defined as a reduction in Ki67 score of greater than or equal to 60 percent. Treatment nonresponse is defined as a reduction of less than 60 percent.

  up to 4 weeks on study and up to 7 weeks on study

Secondary Outcomes (5)

• Qualitative Analysis of 18F-FFNP uptake

  imaging takes up to 2 hours during a visit and will take place up to 4 weeks and up to 6 weeks for the test-retest Group 3

• Intra- and Inter-Observer Variability of Quantitative Assessment of Tumor 18F-FFNP uptake

  imaging takes up to 2 hours during a visit and will take place up to 4 weeks and up to 6 weeks for the test-retest Group 3

• Quantitative Assessment of Tumor 18F-FFNP: Standardized Uptake Values (SUV)

  imaging takes up to 2 hours during a visit and will take place up to 4 weeks and up to 6 weeks for the test-retest Group 3

• Test-Retest Variability of Quantitative Assessment of Tumor 18F-FFNP uptake

  imaging takes up to 2 hours during a visit and will take place up to 4 weeks and up to 6 weeks for the test-retest Group 3

• NCIC Adverse Events Version 5.0 Frequency Tables

  up to 7 weeks

Other Outcomes (5)

• Summary of Parent and Metabolite Fractions of 18F-FFNP over the course of the scan

  imaging takes up to 2 hours during a visit and will take place up to 4 weeks on study for Group 1

• Statistical Correlation between tumor 18F-FFNP uptake with serum progesterone, estradiol, and corticosteroid binding globulin levels

  imaging takes up to 2 hours during a visit and will take place up to 4 weeks on study for Group 1

• Statistical correlation between 18F-FFNP breast PET/MRI parameters and changes in PR immunohistochemistry in therapy responders and non-responders

  imaging takes up to 2 hours during a visit and will take place up to 4 weeks on study for Group 1, up to 4 weeks and up to 7 weeks for Group 2, and up to 4 weeks and up to 6 weeks for Group 3

Study Arms (3)

Group 1: Metabolite Analysis

EXPERIMENTAL

participants will undergo venous blood sampling during the PET/MRI scan

Drug: 18F-fluorofuranylnorprogesterone; Device: Positron Emissions Tomography / Magnetic Resonance Imaging; Other: Blood Sampling; Drug: FDA-approved gadolinium-based intravenous contrast agent

Group 2: Pre-surgical Treatment

EXPERIMENTAL

participants will undergo PET/MRI scans before and after 2 weeks treatment with anastrozole

Drug: 18F-fluorofuranylnorprogesterone; Device: Positron Emissions Tomography / Magnetic Resonance Imaging; Drug: Anastrozole; Drug: FDA-approved gadolinium-based intravenous contrast agent

Group 3: Test-Retest

EXPERIMENTAL

participants will undergo baseline and repeat PET/MRI scans without intervening treatment to determine repeatability

Drug: 18F-fluorofuranylnorprogesterone; Device: Positron Emissions Tomography / Magnetic Resonance Imaging; Drug: FDA-approved gadolinium-based intravenous contrast agent

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.

Also known as: FFNP

Group 1: Metabolite Analysis; Group 2: Pre-surgical Treatment; Group 3: Test-Retest

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)

Also known as: PET/MRI

Group 1: Metabolite Analysis; Group 2: Pre-surgical Treatment; Group 3: Test-Retest

Anastrozole DRUG

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

Group 2: Pre-surgical Treatment

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

Group 1: Metabolite Analysis

FDA-approved gadolinium-based intravenous contrast agent DRUG

FDA-approved gadolinium-based intravenous contrast agent used for the MRI portion of this study

Also known as: gadopiclenol, gadobenate dimuglumine

Group 1: Metabolite Analysis; Group 2: Pre-surgical Treatment; Group 3: Test-Retest

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 surgery
• Definitive surgical excision of the primary tumor planned without neoadjuvant therapy; defined as therapy (chemotherapy, targeted therapy, radiation therapy or endocrine therapy) given to decrease the size of the tumor prior to planned surgery.

You may not qualify if:

• Inability or unwillingness to provide informed consent to the study
• HER2-positive breast cancer, as defined by immunohistochemical staining 3+ OR positive by in situ hybridization (Group 2 only)
• PR and Ki67 IHC slides or FFPE tissue blocks from clinical breast biopsy not available
• Patients who have completed neoadjuvant chemotherapy, endocrine therapy, targeted therapy, surgical resection, or radiation for the current biopsy-proven malignancy
• Patients who are planning to undergo anastrozole as standard of care neoadjuvant therapy
• Patients who are currently taking aromatase inhibitors or ER antagonists (tamoxifen, raloxifene)
• Patients with breast expanders
• Patients who are pregnant or lactating
• Patients with a contraindication to gadolinium-based contrast agents, including allergy or impaired renal function (per UW Health Guidelines)
• Patients with a history of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-FFNP
• Patients with history of allergic reaction to anastrozole (Group 2 only)
• Patients in liver failure as judged by the patient's physician
• Patients with standard contraindications to MRI (per UW Health Guidelines)
• Patients requiring conscious sedation for imaging are not eligible; patients requiring mild, oral anxiolytics for the clinical MRI scan will be allowed to participate as long as the following criteria are met:
• The patient has their own prescription for the medication

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UW Carbone Cancer Center

Madison, Wisconsin, 53792, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Magnetic Resonance Imaging; Anastrozole; Blood Specimen Collection; gadopiclenol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Amy M Fowler, MD, PHD

  UW Carbone Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cancer Connect

CONTACT

800-622-8922; clinicaltrials@cancer.wisc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Window of Opportunity

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 17, 2023
• Study Start: September 25, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2030
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)