Actively Recruiting
Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment With HER2-targeted Therapy
Led by Vanderbilt-Ingram Cancer Center · Updated on 2026-05-08
30
Participants Needed
1
Research Sites
189 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to determine if the radiotracer, \[68Ga\]Ga-ABY-025, used for PET imaging can help us better identify and visualize lesions or tumors, in patients who are receiving standard of care therapy HER2+ cancers.
CONDITIONS
Official Title
Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment With HER2-targeted Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Patients with unresectable locally advanced or metastatic cancer eligible for standard HER2-targeted therapy with FDA-approved indication
- Planning to start or recently started HER2-targeted therapy with no more than 6 cycles completed
- Previous biopsy showing HER2 expression or amplification in at least one lesion
- Measurable disease outside the liver on CT, FDG-PET, or MRI for RECIST evaluation
- Life expectancy of at least 6 months
- Patients with brain metastases are allowed
You will not qualify if you...
- Measurable disease only in the liver
- Unable to comply with study procedures
- Allergy or hypersensitivity to any component of [68Ga]Ga-ABY-025
- Pregnant or breastfeeding
- HER2-negative cancers without FDA-approved HER2-directed therapy indication
- Unable to lie flat for 30 minutes during imaging
- Medical or psychiatric conditions that prevent successful study participation per treating physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
M
Makenna Brown
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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