Testing a New Imaging Agent to Identify Cancer (NCT04692831) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Testing a New Imaging Agent to Identify Cancer
United States60 participantsStarted 2020-11-30
Plain-language summary
The purpose of this study is to see whether 89Zr-ss-pertuzumab is safe in people with HER2+ cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Biopsy proven HER2-positive or HER2-low primary malignancy or metastatic disease
Note: HER2 positivity is defined according to American Society of Clinical Oncology guidelines or ERBB2 amplification on next generation sequencing Note: HER2-low is defined as low HER2 expression, with immunohistochemistry (IHC) 1+ or IHC 2+ and in situ hybridization \[ISH\]-negative, including FISH.
* Biopsy proven primary malignancy or metastatic disease
* At least one malignant lesion on CT, MR, or FDG PET/CT within 60 days of protocol enrollment
* Age 18 years or greater
* ECOG performance of 0-2
Exclusion Criteria:
* Creatinine \> 2 times normal limit (obtained with 8 weeks of enrollment)
* AST/ALT \> 2 times normal limit (obtained with 8 weeks of enrollment)
* Life expectancy \< 3 months
* Pregnancy or lactation
* Patients who cannot undergo PET/CT due to weight limits (over 450 pounds)