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RecruitingEarly Phase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 3 visits, 1 visit
  • Time periods mentioned: 5 years
  • Procedures mentioned: Blood draws, MRI scans, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Once consented, vital signs will be taken, a blood draw to determine kidney function, and a pregnancy test will be performed for women of childbearing potential."
  • "Participants will be asked to fill out an MRI questionnaire and they will be given an additional information sheet on the gadolinium-based contrast agent, Prohance, that the FDA requires for all patients receiving this type of drug."
  • "Because the PET/MRI is smaller than most MRI scanners, participants will have a PET/MRI fit test to ensure a proper fit."
  • "Imaging visits During this study participants will be scheduled for up to 3 imaging visits."
  • "Imaging Visit #1 This visit will take about 4 hours and will take place before the participant starts immunotherapy."
  • "Participants will then be positioned in the PET/MRI scanner."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether PET/MRI scans using FMISO, an imaging tracer, can track and predict how well immunotherapy works. It is for adults with stage II–IV triple-negative breast cancer who have not started immunotherapy, a treatment that helps the immune system fight cancer. Your cancer doctor chooses your treatment plan, and these scans will not guide treatment decisions.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 to 75 years old.
  • A biopsy (tissue test) shows stage II–IV triple-negative breast cancer.
  • Your cancer tests more than 50% positive for PD-L1, a protein.
  • You can receive immunotherapy but have not started it.
  • You are not pregnant or breastfeeding and are willing to sign a consent form.
  • A kidney function test within 30 days meets the study center’s rules.
  • You are expected to live more than one year.
  • You have at least one tumor larger than 1 cm that can be measured on a breast MRI or staging CT scan.

Who can't join

  • You cannot give informed consent to join.
  • You weigh more than 350 pounds, due to the scanner’s size.
  • You are breastfeeding, pregnant, or may be pregnant. If you can become pregnant, you need a negative blood pregnancy test within 48 hours or a negative urine test within 24 hours before each PET scan.
  • You cannot safely have an MRI, such as because of metal implants that cannot be removed or certain tattoos.
  • You cannot lie still on the scan table for one hour.
  • You cannot safely receive ProHance (gadoteridol), a contrast dye used for MRI.
  • You have received immunotherapy before or after surgery.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

AL