Monitoring HER2+ Breast Cancer Neoadjuvant Treatment With Advanced PET/MRI

NCT04332588 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 300005387O'Neal Invests Award
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to see if using an investigational drug called \[18F\]FMISO with PET/MRI imaging can help monitor and predict the effect of trastuzumab (Herceptin) on chemotherapy in patients diagnosed with advanced HER2 positive breast cancer. This study is for imaging purposes only and is not a treatment study. The results of this study will not change a patient's clinical treatment plan but it may help physicians and researchers better understand how best to treat patients with breast cancer in the future.

Conditions

HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (6)

• Baseline measure of PET standardized uptake value (SUV).

  Compare baseline metrics from PET/MRI

  Baseline

• Baseline measure of apparent diffusion coefficient (ADC) in mm2/sec from MRI.

  Compare baseline metrics from PET/MRI

  Baseline

• Baseline measure of signal enhancement ratio (SER) from MRI.

  Compare baseline metrics from PET/MRI

  Baseline

• Changes in SER from MRI

  Compare percent change of SER from imaging visit 3 to the baseline.

  Baseline through 6 months

• Changes in ADC from MRI

  Compare percent change of ADC (mm2/sec) from imaging visit 3 to the baseline.

  Baseline through 6 months

• Changes in SUV from PET

  Compare percent change of SUV from imaging visit 3 to the baseline.

  Baseline through 6 months

Secondary Outcomes (5)

• Follow-up

  Baseline through 5 years

• Follow-up

  Baseline through 5 years

• Changes in ADC (mm2/sec) from MRI.

  Baseline through 2 months

• Changes in SER from MRI.

  Baseline through 2 months

• Changes in SUV from PET.

  Baseline through 2 months

Study Arms (2)

Herceptin monotherapy cohort

EXPERIMENTAL

Herceptin monotherapy cohort. Locally advanced HER2+ breast cancer patients receiving neoadjuvant Herceptin monotherapy prior to combination therapy will undergo three contrast-enhanced \[18F\]FMISO PET/MRI scans. Each imaging session will be identical. Imaging session one will be after diagnosis and before beginning monotherapy. Imaging session two will be within 10 days prior to beginning combination therapy with targeted HER2 agents. Imaging session three will be within 10 days prior to beginning the second round of combination therapy with targeted HER2 agents.

Drug: [18F]FMISO PET/MRI imaging

Combination therapy cohort

EXPERIMENTAL

Locally advanced HER2+ breast cancer patients that receiving neoadjuvant combination therapy including Herceptin will undergo two contrast-enhanced \[18F\]FMISO PET/MRI imaging. Imaging session one will be after diagnosis and before beginning combination therapy. Imaging session two will be within 10 days prior to beginning the second round of combination therapy with targeted HER2 agents.

Drug: [18F]FMISO PET/MRI imaging

Interventions

[18F]FMISO PET/MRI imaging DRUG

\[18F\]FMISO PET/MRI imaging

Combination therapy cohort; Herceptin monotherapy cohort

Eligibility Criteria

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

You may qualify if:

• Patients must be ≥ 18 years old and ≤ 75 years old
• HER2+ breast cancer determined on primary tumor by a local pathology laboratory and defined as IHC score 3+ and/or positive by ISH (defined by ISH ratio of ≥ 2.0 for the number of HER2 gene copies to the number of chromosome 17 copies). Only one positive result is required for eligibility
• Locally advanced stage II-III HER2+ breast cancer patients eligible for neoadjuvant therapy who are naïve to beginning treatment
• Estimated life expectancy of greater than one year
• Patients must have one lesion with RECIST measurable disease (great than 1 cm in diameter)

You may not qualify if:

• Inability to provide informed consent F
• Weight over 350 lbs., due to the scanner bore size
• Lactating, known or suspected pregnancy. Women with child-bearing potential must a have a negative serum β-hCG pregnancy test within 48 hours or a negative urine β-hCG pregnancy test within 48 hours of each PET imaging study.
• Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)
• Unable to lie still on the imaging table for one (1) hour
• contraindication for gadolinium-based contrast agent, ProHance (gadoteridol)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

The University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

RECRUITING

Study Officials

• Jonathan McConathy, MD, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Sorace, PhD

CONTACT

205-934-3116; asorace@uabmc.edu

Sebastian Eady

CONTACT

2059962636; smeady@uabmc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Advanced Imaging Facility, Director, Division of Molecular Imaging and Therapeutics Professor, Division of Molecular Imaging and Therapeutics

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: April 2, 2020
• Study Start: March 25, 2022
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

US (1)