Actively Recruiting

Phase 1
Age: 18Years +
FEMALE
NCT04332588

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

Led by University of Alabama at Birmingham · Updated on 2025-05-29

25

Participants Needed

1

Research Sites

279 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must be between 18 and 75 years old
  • HER2-positive breast cancer confirmed by local pathology with IHC score 3+ or positive ISH test
  • Patients with locally advanced stage II-III HER2-positive breast cancer eligible for neoadjuvant therapy and have not started treatment
  • Estimated life expectancy greater than one year
  • Must have at least one measurable tumor lesion greater than 1 cm in diameter
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent
  • Weight over 350 pounds due to scanner size limits
  • Lactating, pregnant, or suspected pregnancy; women of childbearing potential must have negative pregnancy test within 48 hours before each imaging visit
  • Contraindications to MRI such as non-removable metal implants or certain tattoos
  • Unable to lie still on the imaging table for one hour
  • Contraindications to the gadolinium-based contrast agent ProHance (gadoteridol)

AI-Screening

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Trial Site Locations

Total: 1 location

1

The University of Alabama at Birmingham

Birmingham, Alabama, United States, 35249

Actively Recruiting

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Research Team

A

Anna Sorace, PhD

CONTACT

S

Sebastian Eady

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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