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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT04332588
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • [18F]FMISO PET/MRI imaging — DRUG
    \[18F\]FMISO PET/MRI imaging

Study Details

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.

Key Dates

Start date
Mar 25, 2022
Status verified
May 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Herceptin monotherapy cohort
    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.
  • Experimental: Combination therapy cohort
    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.

Primary Outcome Measure

Baseline measure of PET standardized uptake value (SUV). [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Alabama at BirminghamBirminghamAlabama35249
April Riddle, BSRT
[email protected]
205-934-6504

Find similar trials in Birmingham, AL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
The University of Alabama at Birmingham· Birmingham, AL

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