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Monitoring Breast Cancer Immunotherapy Treatment With Advanced PET/MRI: A Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04861077
Recruitment Status : Not yet recruiting
First Posted : April 27, 2021
Last Update Posted : April 27, 2021
Information provided by (Responsible Party):
Janis P. O'Malley, MD, University of Alabama at Birmingham

Brief Summary:
This clinical study will investigate the utility of [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.

Condition or disease Intervention/treatment Phase
Triple Negative Breast Cancer Stage II-IV Drug: [18F]FMISO-PET with contrast-enhanced MRI Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Monitoring Breast Cancer Immunotherapy Treatment With Advanced PET/MRI: A Pilot Study
Estimated Study Start Date : August 2, 2021
Estimated Primary Completion Date : August 2, 2026
Estimated Study Completion Date : August 2, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Breast [18F]FMISO-PET with contrast-enhanced MRI

The patient will have a plastic peripheral intravenous catheter placed in the arm for administration of 10 mCi/10mL [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.

Drug: [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 Measures :
  1. Baseline measure of PET standardized uptake value (SUV). [ Time Frame: Baseline ]
    Compare baseline metrics from PET/MRI

  2. Baseline measure of apparent diffusion coefficient (ADC) in mm2/sec from MRI. [ Time Frame: Baseline ]
    Compare baseline metrics from PET/MRI.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 eligble
  3. >50% 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04861077

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Contact: Sebastian Eady 205-996-2636

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United States, Alabama
Birmingham, Alabama, United States, 35249
Contact: Sebastian Eady    205-966-2636   
Sponsors and Collaborators
University of Alabama at Birmingham
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Principal Investigator: Janis O'Malley, MD University of Alabama at Birmingham
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Responsible Party: Janis P. O'Malley, MD, Former Director, Division of Molecular Imaging and Therapeutics Professor, Division of Molecular Imaging and Therapeutics, University of Alabama at Birmingham Identifier: NCT04861077    
Other Study ID Numbers: R21-072
First Posted: April 27, 2021    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases