Monitoring HER2-positive breast cancer treatment with advanced imaging techniques

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of an investigational imaging agent, [18F]FMISO, in conjunction with PET/MRI imaging to monitor the response of HER2-positive breast cancer patients to trastuzumab (Herceptin) during neoadjuvant chemotherapy. Participants will undergo a series of imaging visits based on their treatment cohort, which will include pre-study assessments and PET/MRI scans after the administration of the imaging agent. The study is designed to enhance understanding of treatment responses in HER2-positive breast cancer, although it will not alter current treatment plans for participants.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients must be ≥ 18 years old and ≤ 75 years old
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. Locally advanced stage II-III HER2+ breast cancer patients eligible for neoadjuvant therapy who are naïve to beginning treatment
4. Estimated life expectancy of greater than one year
5. Patients must have one lesion with RECIST measurable disease (great than 1 cm in diameter)

Exclusion Criteria:

1. Inability to provide informed consent F
2. Weight over 350 lbs., due to the scanner bore size
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. Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)
5. Unable to lie still on the imaging table for one (1) hour
6. contraindication for gadolinium-based contrast agent, ProHance (gadoteridol)

Where it's running

• The University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting

Study contacts

• Principal investigator: Jonathan McConathy, MD, PhD — University of Alabama at Birmingham
• Study coordinator: Anna Sorace, PhD
• Email: asorace@uabmc.edu
• Phone: 205-934-3116

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.