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18F-FFNP PET/MRI for Breast Cancer

Phase 2

Recruiting

Led By Amy M Fowler, MD, PHD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of biopsy-proven invasive breast cancer measuring at least 1.0 cm in diameter by any imaging modality

Biopsy-proven ER-positive, PR-positive, HER2-negative invasive breast cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years (long term follow up)

Awards & highlights

Study Summary

This trial will test if an imaging method can predict how a patient will respond to a hormone-based therapy for breast cancer.

Who is the study for?

This trial is for postmenopausal women with newly diagnosed ER+/PR+/HER2- primary breast cancer, who haven't had any neoadjuvant therapy and are planning surgery. They must be able to lie prone for imaging, not have allergies to the study drugs or MRI contrast agents, and can't be on hormone replacement therapy.Check my eligibility

What is being tested?

The trial tests if a PET/MRI scan using a tracer called 18F-FFNP can predict how well endocrine therapy will work before surgery in breast cancer patients. It also checks the reliability of this method. Participants will undergo blood sampling and receive Gadobenate dimeglumine and Anastrozole.See study design

What are the potential side effects?

Possible side effects include allergic reactions to the tracer (18F-FFNP) or MRI contrast agent (Gadobenate dimeglumine), discomfort from lying still during scans, bruising from blood sampling, and typical Anastrozole-related effects like joint pain or hot flashes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My breast cancer is ER and PR positive but HER2 negative.

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I am scheduled for surgery to remove my tumor without prior treatment to shrink it.

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I am 60 years or older and postmenopausal.

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I am postmenopausal due to having both ovaries removed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years (long term follow up)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years (long term follow up)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years (long term follow up) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Secondary outcome measures

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

NCIC Adverse Events Version 5.0 Frequency Tables

Qualitative Analysis of 18F-FFNP uptake

+2 more

Other outcome measures

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

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

Statistical correlation between tumor 18F-FFNP uptake with disease recurrence

+2 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Group 3: Test-RetestExperimental Treatment3 Interventions

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

Group II: Group 2: Pre-surgical TreatmentExperimental Treatment4 Interventions

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

Group III: Group 1: Metabolite AnalysisExperimental Treatment4 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Anastrozole

2019

Completed Phase 4

~10300

Gadobenate dimeglumine

2019

Completed Phase 2

~360

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,189 Previous Clinical Trials

3,169,493 Total Patients Enrolled

35 Trials studying Breast Cancer

38,466 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,669 Previous Clinical Trials

40,926,268 Total Patients Enrolled

939 Trials studying Breast Cancer

1,543,307 Patients Enrolled for Breast Cancer

Amy M Fowler, MD, PHDPrincipal InvestigatorUW Carbone Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How secure is the Group 1: Metabolite Analysis for humans?

"Although no efficacy data exists around Group 1: Metabolite Analysis, the presence of safety studies warrants a score of 2."

Answered by AI

Are new participants currently being accepted for this experiment?

"Per the clinicaltrials.gov record, this research has stopped recruiting participants since its most recent update on October 11th 2023. Although no longer enrolling applicants, there are 2730 other studies that are actively searching for volunteers right now."

Answered by AI

What outcomes is this empirical research attempting to ascertain?

"This clinical trial will span up to 4 weeks on-study and an additional 7 weeks post-treatment, with the main objective being to measure percentage changes in Ki67 tumor proliferation scores as a marker of endocrine sensitivity. Further secondary outcomes involve assessing variability in 18F-FFNP uptake using Pitnam-Morgan test for correlated variances and parametric bootstrapping approaches. Intra-observer and inter observer differences between SUVmax, SUVpeak, and SUVmean are also studied during this period."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of 18F-FFNP Breast PET/MRI

2024. "Study of 18F-FFNP Breast PET/MRI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06086704.

All > Madison