RECRUITING

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

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Conditions

HER2-positive Breast Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04
Study Completion:2027-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04332588

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients must be ≥ 18 years old and ≤ 75 years old
  2. 2. 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
  3. 3. Locally advanced stage II-III HER2+ breast cancer patients eligible for neoadjuvant therapy who are naïve to beginning treatment
  4. 4. Estimated life expectancy of greater than one year
  5. 5. Patients must have one lesion with RECIST measurable disease (great than 1 cm in diameter)
  1. 1. Inability to provide informed consent F
  2. 2. Weight over 350 lbs., due to the scanner bore size
  3. 3. 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.
  4. 4. Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)
  5. 5. Unable to lie still on the imaging table for one (1) hour
  6. 6. contraindication for gadolinium-based contrast agent, ProHance (gadoteridol)

Contacts and Locations

Study Contact

Anna Sorace, PhD
CONTACT
205-934-3116
asorace@uabmc.edu
Sebastian Eady
CONTACT
2059962636
smeady@uabmc.edu

Principal Investigator

Jonathan McConathy, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham

Study Locations (Sites)

The University of Alabama at Birmingham
Birmingham, Alabama, 35249
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

  • Jonathan McConathy, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04
Study Completion Date2027-08

Study Record Updates

Study Start Date2025-04
Study Completion Date2027-08

Terms related to this study

Additional Relevant MeSH Terms

  • HER2-positive Breast Cancer