Recruiting
Phase 1

[18F]FMISO with Trastuzumab

Sponsor:

University of Alabama at Birmingham

Code:

NCT04332588

Conditions

HER2-positive Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

[18F]FMISO PET/MRI imaging

Study Details

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

Study ID

NCT04332588

Start date

Mar 25, 2022

Status verified date

Aug, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

25 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

[18F]FMISO PET/MRI imaging

\[18F\]FMISO PET/MRI imaging

Primary outcome measure

  • Baseline measure of PET standardized uptake value (SUV). [ Time Frame: Baseline ]
  • Baseline measure of apparent diffusion coefficient (ADC) in mm2/sec from MRI. [ Time Frame: Baseline ]
  • Baseline measure of signal enhancement ratio (SER) from MRI. [ Time Frame: Baseline ]
  • Changes in SER from MRI [ Time Frame: Baseline through 6 months ]
  • Changes in ADC from MRI [ Time Frame: Baseline through 6 months ]
  • Changes in SUV from PET [ Time Frame: Baseline through 6 months ]

Central Contacts and Locations

Central contacts

Anna Sorace, PhD

205-934-3116asorace@uabmc.edu

Sebastian Eady

2059962636smeady@uabmc.edu

Locations

The University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35249

Contacts

April Riddle, BSRT

205-934-6504ariddle@uabmc.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-08-17.