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RecruitingPhase 1

Monitoring HER2+ Breast Cancer Neoadjuvant Treatment With Advanced PET/MRI

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 and older
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: 4 visits, 3 visits
  • Time periods mentioned: 5 years
  • Procedures mentioned: MRI scans, Blood draws, 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
  • "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."
  • "If the patient is in cohort #1, they will make 4 visits to UAB."
  • "During the pre-study visit, once consented, they will have a blood draw to determine kidney function, and a pregnancy test if they are a woman of childbearing potential."
  • "Their vital signs will be taken, they will be asked to fill out an MRI questionnaire, and they will have a PET/MRI fit test."
  • "A plastic catheter will be placed into a vein in their arm and they will then be positioned in the PET/MRI scanner."
  • "If the patients are in cohort #2, they will make 3 visits to UAB."
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 an experimental imaging drug called [18F]FMISO, used with PET/MRI scans, can help track and predict how well Herceptin and chemotherapy work. It is for adults with advanced HER2-positive breast cancer, a cancer with high levels of a protein called HER2. This is an imaging study, not a treatment study, and it will not change your treatment plan.

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.

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 lab test of your original breast tumor shows it is HER2-positive. One positive result from either an IHC or ISH test is enough.
  • You have stage II or III HER2-positive breast cancer and can receive treatment before surgery, but have not started treatment.
  • You are expected to live more than one year.
  • You have at least one tumor larger than 1 centimeter that can be measured using the study’s rules.

Who can't join

  • You cannot give informed consent, meaning you cannot agree to join after learning about the study.
  • You weigh more than 350 pounds because of the scanner’s size.
  • You are breastfeeding, pregnant, or may be pregnant. If you can become pregnant, you must have a negative blood or urine pregnancy test within 48 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 to make MRI images clearer.

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. 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 sites (1)

AL