Actively Recruiting
HER2 Targeted Molecular Imaging in mBC Using 68Ga-ABS011
Led by Abscint NV/SA · Updated on 2025-05-21
60
Participants Needed
6
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II study aims to confirm the diagnostic performance and accuracy of 68Ga-ABS011 PET/CT in determining the HER2 expression status, and to evaluate 68Ga-ABS011's ability to drive changes in therapeutic treatment. 68Ga-ABS011 will be compared to the current standard of care (SOCa) diagnostic methods including immunohistochemistry (IHC), in situ hybridization (ISH) and imaging tools used for treatment response follow-up including Fluorodeoxyglucose F-18 (18F-FDG) positron emitted tomography (PET) and contrast enhanced computed tomography (ceCT).
CONDITIONS
Official Title
HER2 Targeted Molecular Imaging in mBC Using 68Ga-ABS011
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult (≥ 18 years at the time of informed consent) male or female patient
- Confirmed de novo or pre-treated metastatic breast cancer with multiple previous treatment lines allowed
- Documented hormone receptor positive/HER2 negative, triple-negative, or HER2 positive metastatic breast cancer potentially eligible for HER2 targeted monotherapy
- At least one target biopsiable, FDG positive, non-liver metastatic lesion ≥15 mm on contrast-enhanced CT
- Willingness 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 diagnostic and treatment follow-up phases
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Ability and willingness to provide written informed consent
You will not qualify if you...
- Primary (non-metastatic) breast cancer
- Unwillingness to undergo at least one tumor biopsy
- Refusal to repeat 18F-FDG PET/contrast-enhanced CT assessment if already completed prior to screening
- Tumor lesions cannot be biopsied due to location, tissue type, or increased risk for serious comorbidities based on metastatic 18F-FDG PET/contrast-enhanced CT
- Brain and liver metastases are the only metastatic sites
- Life expectancy less than 3 months
- Pregnancy or breastfeeding
- Inadequate organ function indicated by significant renal impairment (GFR <30 ml/min/1.73m2), low neutrophil count (<1,500 cells/mm3), elevated bilirubin (~1.5 x ULN unless Gilbert's syndrome), or high liver enzymes (>5 x ULN)
- Known hypersensitivity to investigational product components or packaging
- Increased bleeding risk or complications from biopsies, including inability to safely discontinue anticoagulation therapy
- Known hypersensitivity or contraindication to iodinated contrast media not controllable by pre-medication
- Inability to undergo PET/CT scanning (e.g., due to body size or claustrophobia)
- Any condition likely to interfere significantly with study compliance, including psychological, social, or geographical factors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
OLV Aalst
Aalst, East-Flanders, Belgium, 9300
Actively Recruiting
2
AZ Delta CHIREC
Brussels, Belgium, 1070
Actively Recruiting
3
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1070
Actively Recruiting
4
Free University Brussels (VUB)
Brussels, Belgium, 1070
Actively Recruiting
5
Institut Jules Bordet
Brussels, Belgium, 1070
Actively Recruiting
6
University Hospital Gasthuisberg
Leuven, Belgium
Actively Recruiting
Research Team
K
Karine Clauwaert
CONTACT
D
Dieter Frijns
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here