Actively Recruiting

Early Phase 1
Age: 18Years - 75Years
FEMALE
NCT04861077

Monitoring Breast Cancer Immunotherapy Treatment With Advanced Positron Emission Tomography Magnetic Resonance Imaging (PET/MRI)

Led by University of Alabama at Birmingham · Updated on 2026-02-20

20

Participants Needed

1

Research Sites

113 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This clinical study will investigate the utility of Fludeoxyglucose (18F) fluoromisonidazole (FMISO), in patients diagnosed with triple negative breast cancer (stage II-IV disease), to monitor and predict the effect of immunotherapy. This is a parallel imaging study to current treatment strategies and no clinical decisions or outcomes will be based on the imaging. If promising, this data will be used to design larger trials. A total of 20 patients will be recruited for this study. This trial will not designate the participant's treatment plan; they will be eligible based on their treatment plan designated from their oncologist.

CONDITIONS

Official Title

Monitoring Breast Cancer Immunotherapy Treatment With Advanced Positron Emission Tomography Magnetic Resonance Imaging (PET/MRI)

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must be 18 years or older and 75 years or younger
  • Biopsy-proven triple negative breast cancer (TNBC) stage II-IV
  • More than 50% Programmed death-ligand 1 (PD-L1) positive
  • Eligible for immunotherapy and have not started any immunotherapy treatment
  • Not pregnant or breastfeeding
  • Willing to sign consent
  • Adequate creatinine clearance within 30 days
  • Estimated life expectancy greater than one year
  • At least one lesion with RECIST measurable disease greater than 1 cm in diameter
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent
  • Weight over 350 lbs due to scanner size
  • Lactating, known or suspected pregnancy; negative pregnancy test required before PET imaging
  • Contraindications for MRI such as non-removable metal implants or certain tattoos
  • Unable to lie still for one hour during imaging
  • Contraindication for gadolinium-based contrast agent Prohance (gadoteridol)
  • Have received immunotherapy in the neoadjuvant or adjuvant setting

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UAB

Birmingham, Alabama, United States, 35249

Actively Recruiting

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Research Team

S

Sebastian Eady

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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