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RecruitingEarly Phase 1

Positron Emission Tomography (PET) Imaging With Zirconium-89 (89Zr)-Trastuzumab for Prediction of HER2 Targeted Therapy Effectiveness

PET Imaging With 89Zr-Trastuzumab for Prediction of HER2 Targeted Therapy Effectiveness

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

  • Procedures mentioned: MRI scans

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
  • "We are proposing to perform a pilot study with goals of demonstrating the feasibility of imaging breast cancer patients with 89Zr-trastuzumab-PET/MRI, evaluating the relationship between tumor 89Zr-trastuzumab uptake and in vitro positivity of HER2, assessing the relationship between 89Zr-trastuzumab uptake and response to HER2 therapy."
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 small study tests whether PET/MRI scans using 89Zr-trastuzumab, a radioactive imaging drug, can help predict who will respond to HER2-targeted treatment used alone. It is for adults with HER2-positive breast cancer, a cancer with high levels of a protein called HER2.

Our goal is to investigate the use of 89Zr-trastuzumab as a HER2 imaging agent to determine which patients are likely to respond to targeted HER2 agents as single agent therapy. We are proposing to perform a pilot study with goals of demonstrating the feasibility of imaging breast cancer patients with 89Zr-trastuzumab-PET/MRI, evaluating the relationship between tumor 89Zr-trastuzumab uptake and in vitro positivity of HER2, assessing the relationship between 89Zr-trastuzumab uptake and response to HER2 therapy.

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 at least 18 years old.
  • Lab tests show HER2-positive breast cancer that meets the study’s test rules.
  • You can receive radiation treatment or treatment with drugs that include at least one HER2-targeted drug.
  • You can do all your usual activities, or you have limits on hard physical activity but can walk and do light work.
  • A heart scan shows your heart pumps out more than 50% of the blood in its main pumping chamber with each beat.

Who can't join

  • You cannot give informed consent, which means understanding the study and agreeing to join.
  • You are pregnant.
  • You cannot lie still for the scan.
  • You weigh more than 350 pounds, due to the scanner’s size.
  • You cannot safely have an MRI, such as because of metal implants that cannot be removed or certain tattoos.

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

Official eligibility criteria

Inclusion Criteria: * Be at least 18 years of age. * Diagnosis of HER2 positive breast cancer as defined by to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) 2018 guidelines: Immunohistochemistry (IHC) 3+ OR Single prove In situ hybridization (ISH) with average HER2 copy number \>= 6 OR dual probe ISH with both average HER2 copy number \>= 4 AND HER2 to CEP17 ratio \>=2 * Patients eligible for radiation therapy or systemic therapy using a regimen containing at least one anti-HER2 agent * Eastern Cooperative Oncology Group (ECOG) performance status of 0 and 1 * Ejection fraction greater than 50% by echocardiogram or multiple-gated acquisition (MUGA) scans Exclusion Criteria: * Inability to provide informed consent * Pregnancy * Inability to lie still for the imaging study * Weight over 350 lbs., due to the scanner bore size * Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)

Study sites (1)

AL