FFNP-PET/MR Imaging for Breast Cancer

Overseen By Gemma Gliori, MS

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: University of Wisconsin, Madison

Must not be taking: Chemotherapy, Endocrine therapy

Disqualifiers: Pregnancy, Breast expanders, Liver failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging method for breast cancer by testing a special tracer called FFNP ([18F]Fluorofuranylnorprogesterone). The goal is to determine if this imaging can accurately measure a protein in cancer cells linked to the hormone progesterone. Women with invasive breast cancer, scheduled for a breast MRI, and with a confirmed diagnosis of a progesterone receptor-positive or negative tumor may be suitable for this study. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in breast cancer imaging.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently undergoing or have recently received chemotherapy or endocrine therapy within the last 6 months.

What prior data suggests that FFNP-PET/MR imaging is safe for breast cancer patients?

Research has shown that 18F-Fluorofuranylnorprogesterone (FFNP) is used in PET/MRI scans to assess progesterone receptor levels in breast cancer, aiding in predicting treatment response. While detailed safety reports from these studies are lacking, the FFNP imaging agent has been used in other trials without major safety issues.

As this trial is in an early phase, limited data exists on its tolerability. However, its progression to this phase indicates some safety in earlier testing. If the FFNP agent has approval for other conditions, it may also suggest safety for new uses. Prospective participants should discuss any concerns or questions with their doctor before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about [18F]Fluorofuranylnorprogesterone (FFNP) because it offers a novel approach to imaging progesterone receptor-positive (PR+) breast cancer. Unlike traditional imaging techniques, FFNP is a radiotracer specifically designed to bind to progesterone receptors, potentially providing clearer and more specific images of PR+ tumors. This targeted imaging could improve diagnostic accuracy and help tailor treatment plans more effectively. The use of PET/MRI with FFNP might also reduce the need for invasive biopsies, making it a less burdensome option for patients.

What evidence suggests that FFNP PET/MRI is effective for measuring progesterone receptor expression in breast cancer?

Studies have shown that 18F-Fluorofuranylnorprogesterone (FFNP) effectively helps doctors visualize progesterone receptors in breast cancer. In this trial, participants will receive FFNP for PET/MRI imaging to assess biopsy-proven primary PR+ breast malignancies. This technique uses PET/MRI scans to measure the amount of the progesterone receptor (PR) protein in the cancer. Research has indicated that FFNP PET/MRI is safe, with no reported side effects. Early results suggest that this method could help predict a tumor's response to hormone treatments before surgery. Thus, FFNP could be a valuable tool in planning optimal treatment for breast cancer patients. ^{1 2 3 4 5}

Who Is on the Research Team?

Amy Fowler, MD, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for women over 18 with invasive breast cancer that's at least 1 cm big, as seen on any imaging test. They must be getting a diagnostic MRI and have PR-positive or PR-negative breast cancer. It's not for those who can't lie prone for the scan, have liver failure, MRI contraindications like claustrophobia or certain implants, allergies to FFNP or gadolinium contrast agents, recent neoadjuvant therapy/surgery/radiation, are pregnant/lactating, exceed the scanner size limit, or have breast expanders.

Inclusion Criteria

My breast cancer is confirmed by biopsy and measures at least 1.0 cm.

My breast cancer is confirmed by biopsy to be either PR-positive or PR-negative.

I am a woman aged 18 or older.

Exclusion Criteria

Your body is too big to fit inside the PET/MRI scanner.

I cannot lie on my stomach for 30 minutes.

I am currently on or recently had chemotherapy or hormone therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo FFNP PET/MRI imaging to assess PR+ breast malignancies

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• [18F]Fluorofuranylnorprogesterone (FFNP)

Trial Overview The study tests if PET/MRI scans using a tracer called [18F]Fluorofuranylnorprogesterone (FFNP) can accurately measure progesterone receptor levels in invasive breast cancer. The idea is that the maximum signal from FFNP on the scan will match up well with lab scores of hormone receptor status.

How Is the Trial Designed?

Group I: FFNP PET/MRI Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Published Research Related to This Trial

The synthesized compound 21-[18F]fluoro-16 alpha-ethyl-19-norprogesterone (FENP) shows high affinity for the progesterone receptor and can be produced in a two-step synthesis with a yield of 4-30% within 40 minutes after [18F]fluoride ion production.

In vivo studies in estrogen-primed rats reveal that [18F]FENP has highly selective uptake in the uterus, indicating its potential for imaging progestin target tissues and receptor-rich tumors, such as breast tumors, using positron emission tomography.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

21-[18F]fluoro-16 alpha-ethyl-19-norprogesterone: synthesis and target tissue selective uptake of a progestin receptor based radiotracer for positron emission tomography. Pomper, MG., Katzenellenbogen, JA., Welch, MJ., et al.[2019]

A new fluorine-18 labeled analogue of Tanaproget, designed for imaging progesterone receptors (PRs) in breast tumors, shows high uptake in target tissues, indicating its potential effectiveness for positron emission tomography (PET) imaging.

The compound demonstrated excellent selectivity and prolonged retention in tissues, with significant differences in uptake between target tissues and blood, suggesting it could be a valuable tool for guiding endocrine therapy in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of [F-18]fluorine-substituted Tanaproget as a progesterone receptor imaging agent for positron emission tomography. Lee, JH., Zhou, HB., Dence, CS., et al.[2015]

The study identified 21-fluoro-16 alpha-methyl-19-norprogesterone ([18F]FMNP) as a promising imaging agent for detecting progesterone receptor positive tumors, showing high specificity and minimal binding to other steroid receptors.

In vivo tests in rats demonstrated that [18F]FMNP had significantly higher uptake in uterine and tumor tissues compared to blood, correlating strongly with progesterone receptor concentrations, indicating its potential for effective imaging of progesterone receptor positive neoplasms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preclinical evaluation of a positron emitting progestin ([18F]fluoro-16 alpha-methyl-19-norprogesterone) for imaging progesterone receptor positive tumours with positron emission tomography. Verhagen, A., Luurtsema, G., Pesser, JW., et al.[2019]

The study demonstrated that (18)F-FFNP PET is a safe and effective method for imaging progesterone receptors in breast cancer, with no adverse effects reported in 20 patients.

While the maximum uptake of (18)F-FFNP was similar in both PR-positive and PR-negative tumors, the tumor-to-normal breast activity ratio was significantly higher in PR-positive cancers, indicating better imaging potential for these tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of progesterone receptors in breast carcinoma by PET with 21-18F-fluoro-16α,17α-[(R)-(1'-α-furylmethylidene)dioxy]-19-norpregn-4-ene-3,20-dione. Dehdashti, F., Laforest, R., Gao, F., et al.[2021]

In a study of 43 postmenopausal women with advanced ER+ breast cancer, a one-day estradiol challenge significantly increased tumor uptake of the progestin analog FFNP in those who responded to endocrine therapy, indicating a strong predictive relationship (100% sensitivity and specificity).

The study found that responders to endocrine therapy not only showed increased FFNP uptake but also experienced significantly longer survival compared to nonresponders, highlighting the potential of this method to guide treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of PET-based estradiol-challenge test for breast cancer progesterone receptors with response to endocrine therapy. Dehdashti, F., Wu, N., Ma, CX., et al.[2021]

Novel PET tracers, such as FES and FFNP, are being developed to measure estrogen and progesterone receptor density in breast cancer, which can help in selecting targeted therapies.

These investigational tracers are advancing towards clinical use and may significantly improve the characterization of breast cancer biology, enhancing the ability to monitor treatment responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel methods and tracers for breast cancer imaging. Linden, HM., Dehdashti, F.[2013]

Positron emission tomography/computed tomography (PET/CT) is a rapidly growing imaging technique in cancer management, but the commonly used radiotracer [(18)F]fluorodeoxyglucose (FDG) is not specific for malignant disease, highlighting the need for more tumor-specific PET radiopharmaceuticals.

Over the past 15 years, various alternative (18)F-labeled radiotracers have been developed and evaluated, which may provide better characterization of tumor biology, emphasizing the importance of regulatory compliance and safety in their clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

(18)F-labeled positron emission tomographic radiopharmaceuticals in oncology: an overview of radiochemistry and mechanisms of tumor localization. Vallabhajosula, S.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06086704

NCT06086704 | Study of 18F-FFNP Breast PET/MRI This clinical trial will investigate an estrogen-regulated parameter as an early measure of endocrine therapy response: progesterone receptor (PR) protein ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7465097/

PET Imaging Agents (FES, FFNP, and FDHT) for Estrogen ... This review covers our development of three PET imaging agents, 16α-[ 18 F]fluoroestradiol (FES) for ER, 21-[ 18 F]fluoro-furanyl-nor-progesterone (FFNP) for ...

3. withpower.com withpower.com/trial/phase-2-breast-neoplasms-2024-052ff

18F-FFNP PET/MRI for Breast Cancer The study demonstrated that (18)F-FFNP PET is a safe and effective method for imaging progesterone receptors in breast cancer, with no adverse effects reported ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03212170

Study Details | NCT03212170 | FFNP-PET/MR Imaging of ... The goal of this research is to test the accuracy of PET/MRI imaging with 18F-fluorofuranylnorprogesterone (FFNP) for measuring progesterone receptor (PR) ...

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-08594

18F-FFNP PET/MRI for the Assessment of Early Response ... This trial may help doctors find out if 18F-FFNP PET/MRI can help determine which tumors will respond best to endocrine therapy given before surgery, such as ...