FFNP-PET/MR Imaging of Progesterone Receptor Expression in Invasive Breast Cancer

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-13

Study Completion Date

2024-11-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this research is to test the accuracy of PET/MRI imaging with 18F-fluorofuranylnorprogesterone (FFNP) for measuring progesterone receptor (PR) expression in patients with invasive breast cancer. The hypothesis is that FFNP SUVmax from PET/MRI will correlate well against the semi-quantitative PR immunohistochemistry score.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of 18F-FFNP Breast PET/MRI

NCT06086704

Breast Cancer

RECRUITING PHASE2

Assessment of Progesterone Receptors in Breast Carcinoma by Positron Emission Tomography (PET) Using Fluoro Furanyl Norprogesterone (FFNP)

NCT00968409

Breast Cancer

COMPLETED PHASE1

[18F]FTT Positron Emission Tomography for the Measurement of PARP Tumor Expression in Patients With Metastatic Breast Cancer

NCT06502691

Anatomic Stage IV Breast Cancer AJCC v8 Metastatic Breast Carcinoma

RECRUITING PHASE1/PHASE2

Fluoroestradiol PET Imaging in Predicting Response to Hormone Therapy of Breast Cancer

NCT01627704

Metastatic Breast Cancer

COMPLETED NA

[18F]FES PET/CT in Endocrine Refractory Breast Cancer

NCT02409316

Estrogen Receptor Positive Breast Cancer Breast Neoplasm Metastatic Breast Cancer

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Integrated whole-body magnetic resonance imaging (MRI)-positron emission tomography (PET) scanners have recently been introduced for clinical use. This technology combines the anatomic and perfusion data obtained with dynamic contrast enhanced (DCE) MRI with functional imaging data obtained from PET. For breast imaging, the combination of MRI and PET has important potential to improve diagnostic accuracy and provide molecular characterization of breast cancer. The overall purpose of this research is to test the accuracy of PET/MRI imaging with 18F-fluorofuranylnorprogesterone (FFNP) for measuring progesterone receptor (PR) expression in patients with invasive breast cancer.

This is a prospective, one-arm, study which will enroll patients with newly diagnosed breast cancer scheduled for diagnostic breast MRI for preoperative staging/extent of disease evaluation as part of standard of care. Participation in this research study includes a directed breast PET/MRI with the investigational radiopharmaceutical, FFNP. FFNP uptake of the known, biopsy-proven malignancy will be measured on the PET/MRI examinations using standardized uptake values (SUV) and tumor-to-normal tissue ratios.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Invasive Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single Group Assignment

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FFNP PET/MRI

18F-Fluorofuranylnorprogesterone (FFNP) administration for PET/MRI imaging to assess biopsy-proven primary PR+ breast malignancies.

Group Type EXPERIMENTAL

[18F]Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging

Intervention Type DRUG

18F-Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging tracer

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

[18F]Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging

18F-Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging tracer

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

FFNP

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Women 18 years of age or older
* Diagnosis of biopsy-proven invasive breast cancer measuring at least 1.0 cm in diameter by any imaging modality
* Biopsy-proven PR-positive or PR-negative invasive breast cancer
* Undergoing diagnostic breast MRI ordered by the referring clinician for staging and extent of disease

Exclusion Criteria

* Inability or unwillingness to provide informed consent to the study
* Participants currently undergoing neoadjuvant chemotherapy/endocrine therapy or those who have received chemotherapy/endocrine therapy within 6 months prior to the MRI
* Participants who have had neoadjuvant chemotherapy/endocrine therapy, surgical intervention, or radiation for the current biopsy-proven malignancy
* Participants with breast expanders
* Participants who are or might be pregnant or lactating
* Participants with a contraindication to gadolinium based contrast agents, including allergy or impaired renal function (per University of Wisconsin Health Guidelines)
* Participants with a history of allergic reaction attributable to compounds of similar chemical or biologic composition to FFNP
* Participants in liver failure as judged by the patient's physician
* Participants with standard contraindications to MRI, including claustrophobia and metallic implants incompatible with MRI
* Participants requiring intravenous (IV) conscious sedation for imaging are not eligible; participants requiring mild, oral anxiolytics for the clinical MRI will be allowed to participate as long as the following criteria are met:

* The subject has their own prescription for the medication
* The informed consent process is conducted prior to the self-administration of this medication
* They come to the research visit with a driver
* Participants unable to lie prone for 30 minutes for imaging

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No