Recruiting
Early Phase 1

Fludeoxyglucose (18F)

Sponsor:

University of Alabama at Birmingham

Code:

NCT04861077

Conditions

Triple Negative Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

[18F]FMISO-PET with contrast-enhanced MRI

Study Details

Brief summary:

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

Triple Negative Breast Cancer

Study ID

NCT04861077

Start date

Jun, 2027

Status verified date

Aug, 2026

Completion date

Aug, 2030

Anticipated

Primary completion date

Aug, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patients must be ≥ 18 years old and ≤ 75 years old
2. Triple negative breast cancer (TNBC) patients (biopsy-proven) stage II-IV eligible
3. >50%Programmed death-ligand 1 (PD-L1) positive
4. Eligible for immunotherapy who are naïve to beginning any immunotherapy treatment
5. May not be pregnant or breastfeeding
6. Subjects must be willing to sign consent
7. Adequate creatinine clearance per institutional guidelines and within 30 days
8. Estimated life expectancy of greater than one year
9. Patients must have one lesion with RECIST measurable disease (greater than 1 cm in diameter, measured from diagnostic breast MRI or staging CT)

Exclusion Criteria:

1. Inability to provide informed consent
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 Human chorionic gonadotropin (β-hCG) pregnancy test within 48 hours or a negative urine β-hCG pregnancy test within 24 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)
7. Have received immunotherapy in the neoadjuvant or adjuvant setting

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Breast [18F]FMISO-PET with contrast-enhanced magnetic resonance (MR)

The patient will have a plastic peripheral intravenous catheter placed in the arm for administration of 10 millicuries (mCi)/10milliliters (mL) \[18F\]FMISO (≤ 15 µg/injected dose) followed by an uptake of 120 minutes.

The injection will be infused nominally over one minute followed by a saline flush. After uptake, the patient will be scanned on the PET/MR for 60 minutes and will receive a contrast injection of gadoteridol during the dynamic sequence of the exam. The patient can be scanned on the PET/CT if the PET/MR is unavailable. During this study patients will be scheduled for up to 3 imaging visits. The first imaging visit will be at baseline prior to starting immunotherapy and is required for study eligibility. If for some reason the patient cannot complete the remaining 2 imaging visits, only one additional imaging visit during the identified times is necessary to remain eligible.

Interventions

[18F]FMISO-PET with contrast-enhanced MRI

Triple negative breast cancer patients that are planning to undergo immunotherapy and consent to this study will have 3 imaging visits. Imaging visit 1 will take place before the patients start immunotherapy. Imaging Visit 2 will take place after the patient completes the 1st cycle of immunotherapy and before they start their 2nd cycle. Imaging Visit 3 will take place when the patient completes the 2nd cycle of immunotherapy and before they start the 4th cycle.

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 ]

Central Contacts and Locations

Central contacts

Sebastian Eady

205-996-2636smeady@uabmc.edu

Locations

UAB

Recruiting

Birmingham, Alabama, United States, 35249

Contacts

Sebastian Eady

205-966-2636smeady@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.