Actively Recruiting
Evaluating the Diagnostic Accuracy of 68Ga-ABS011 PET/CT for HER2 Expression in Metastatic Breast Cancer and Other Solid Tumors
Led by Abscint NV/SA · Updated on 2026-06-02
60
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to confirm how well the diagnostic imaging method 68Ga-ABS011 PET/CT detects HER2 expression in metastatic breast cancer and other metastatic solid tumors. The study compares 68Ga-ABS011 PET/CT with current standard tests like immunohistochemistry (IHC), in situ hybridization (ISH), and other imaging methods such as 18F-FDG PET and contrast-enhanced CT. This phase II trial explores whether 68Ga-ABS011 can better identify tumor heterogeneity and improve treatment decisions. Participants will undergo 68Ga-ABS011 PET/CT after completing standard 18F-FDG PET/CT and lesion biopsy with IHC/ISH analysis. 68Ga-ABS011 is a specialized antibody labeled with gallium-68 that binds HER2 tumor markers quickly, allowing whole-body PET/CT imaging with low radiation exposure. This imaging method is designed to reduce false negatives from tumor sampling, detect differences within and between tumors, and support follow-up during HER2 targeted treatment. During the study, participants will have diagnostic imaging, biopsies, and pathology assessments. Researchers will measure how well 68Ga-ABS011 PET/CT agrees with standard HER2 tests immediately after imaging and observe treatment changes. Safety will be monitored for up to six weeks after starting HER2 targeted therapy. The study also evaluates early tumor shrinkage, metabolic response, and tumor heterogeneity to assess the imaging's reliability in guiding treatment and monitoring disease progression.
CONDITIONS
Brief Title
HER2 Targeted Molecular Imaging in mBC and Other Metastatic Solid Carcinomas Using 68Ga-ABS011
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older at the time of informed consent
- Diagnosed with de novo or previously treated metastatic solid tumors
- Documented hormone receptor positive/HER2 negative, triple-negative, or HER2 positive metastatic breast cancer eligible for HER2 targeted therapy, or other metastatic solid tumors
- At least one biopsiable, FDG-positive, non-liver metastatic lesion of 15 mm or larger
- Willing to undergo at least one tumor biopsy
- Male patients able to father children and female patients of childbearing potential agree to use effective contraception during the study phases
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Ability and willingness to provide written informed consent
You will not qualify if you...
- Primary (non-metastatic) solid tumor cancer
- Unwilling to undergo at least one tumor biopsy (recent biopsies before screening not accepted)
- Unwilling to repeat 18F-FDG PET/ceCT assessment if already completed before screening
- Tumor lesions that cannot be biopsied due to location, tissue type, or risk for serious comorbidities
- Brain and liver metastases as the only metastatic sites
- Life expectancy less than 3 months
- Pregnancy or breastfeeding
- Inadequate organ function shown by clinically relevant abnormal lab results, including significant renal impairment, low neutrophil count, high bilirubin, or high liver enzymes
- Known hypersensitivity to investigational product components or packaging
- Increased bleeding risk or biopsy complications that cannot be safely managed
- Known hypersensitivity or intolerance to iodinated contrast media that cannot be prevented
- Inability to undergo PET/CT scanning (e.g., due to body size or claustrophobia)
- Any condition that may interfere with study compliance, such as psychological, social, or geographical issues
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day
Participants undergo a HER2 targeted PET/CT scan using 68Ga-ABS011 after completing a standard 18F-FDG PET/CT and lesion biopsy with IHC/ISH analysis.
1 visit (in-person)
Duration - Up to 6 weeks
Participants are monitored for safety and treatment response for up to 6 weeks after the HER2 targeted monotherapy initiation.
Follow-up visits as needed up to 6 weeks
Trial Site Locations
Total: 7 locations
1
Medizinische Universität Innsbruck
Innsbruck, Tyrol, Austria, A-6020
Actively Recruiting
2
AZ Delta CHIREC
Brussels, Brussels Capital, Belgium, 1070
Actively Recruiting
3
Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital, Belgium, 1070
Actively Recruiting
4
Free University Brussels (VUB)
Brussels, Brussels Capital, Belgium, 1070
Actively Recruiting
5
Institut Jules Bordet
Brussels, Brussels Capital, Belgium, 1070
Actively Recruiting
6
OLV Aalst
Aalst, East-Flanders, Belgium, 9300
Completed
7
University Hospital Gasthuisberg
Leuven, Belgium
Actively Recruiting
Research Team
K
Karine Clauwaert
D
Dieter Frijns
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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