Breast Cancer
Conditions
Keywords
89Zr-Trastuzumab, HER2 Imaging
Brief summary
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.
Interventions
DRUG[89Zr]-Df-Trastuzumab
\[89Zr\]-Df-Trastuzumab will be administered intravenously. The administered dose will be 2 mCi at the time of injection. The amount of injected drug is 5 mg of Trastuzumab.
DIAGNOSTIC_TESTPET/MRI Imaging
5-6 days post injection the patients will undergo PET/MRI imaging.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigate the use of [89Zr]-Df-Trastuzumab as a HER2 imaging agent | 24 months | To measure the diagnostic quality (with standardized uptake values) of PET/MRI imaging with \[89Zr\]-Df-Trastuzumab in patients with newly diagnosed breast cancer. |
Countries
United States
Contacts
CONTACTDenise Jeffers, PharmD
CONTACTSebastian Eady, BS
PRINCIPAL_INVESTIGATORSuzanne E Lapi, PhD
University of Alabama at Birmingham
Outcome results
None listed