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New treatment option for Metastatic Breast Cancer
Official title HER2 Targeted Molecular Imaging in mBC and Other Metastatic Solid Carcinomas Using 68Ga-ABS011
ClinicalTrials.gov ID: NCT06369831
What this study is testing
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult (≥ 18 years at the time of informed consent signature) male or female patient
- Patient with confirmed de novo or pre-treated metastatic solid tumors (multiple previous treatment lines in metastatic setting are allowed). 2.1...
- Patient presenting with at least one target biopsiable, FDG positive , non-liver metastatic lesion of ≥15 mm defined on ceCT (as part of screening...
- Patient willing to undergo at least one tumor biopsy.
- Male patients able to father children and female patients of childbearing potential agree to use effective methods of contraception during the...
You likely can't join if
- Primary (non-metastatic) solid tumor cancer.
- Patient not willing to undergo at least one tumor biopsy. Note: A recent biopsy and accompanied locally assessed IHC/ISH analyses, completed before...
- 18F-FDG PET/ceCT completed before screening and patient not willing to repeat this assessment.
- Metastatic setting 18F-FDG PET/ceCT indicating that the identified tumor lesions cannot be biopsied due their location and/or tissue type and/or an...
- Brain and liver metastases are the sole sites of metastatic disease.
- Life expectancy lower than 3 months.
See the full eligibility criteria
- Adult (≥ 18 years at the time of informed consent signature) male or female patient
- Patient with confirmed de novo or pre-treated metastatic solid tumors (multiple previous treatment lines in metastatic setting are allowed). 2.1. Patients with documented hormone receptor positive/HER2 negative...
- Patient presenting with at least one target biopsiable, FDG positive , non-liver metastatic lesion of ≥15 mm defined on ceCT (as part of screening 18F-FDG PET/ceCT assessment).
- Patient willing to undergo at least one tumor biopsy.
- Male patients able to father children and female patients of childbearing potential agree to use effective methods of contraception during the diagnostic and SOCa treatment follow-up study phases.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to
- Ability and willingness of the research participant to provide written informed consent.
- Primary (non-metastatic) solid tumor cancer.
- Patient not willing to undergo at least one tumor biopsy. Note: A recent biopsy and accompanied locally assessed IHC/ISH analyses, completed before screening, will not be accepted for study purposes.
- 18F-FDG PET/ceCT completed before screening and patient not willing to repeat this assessment.
- Metastatic setting 18F-FDG PET/ceCT indicating that the identified tumor lesions cannot be biopsied due their location and/or tissue type and/or an increased risk for serious comorbidities.
- Brain and liver metastases are the sole sites of metastatic disease.
- Life expectancy lower than 3 months.
- Pregnancy or breastfeeding.
- Inadequate organ function, suggested by clinically relevant abnormal laboratory results:
- Significantly impaired renal function defined as estimated Glomerular Filtration Rate (GFR) \<30 ml/min/1.73m2.
- Absolute neutrophil count \<1,500 cells/mm3.
- Total bilirubin \~1.5 x Upper Limit of Normal (ULN) (unless the patient has documented Gilbert's syndrome).
- Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or Alanine aminotransferase (ALT)/ serum glutamic pyruvic transaminase (SGPT) \>5.0 x ULN.
- Patients with a known hypersensitivity to any of the investigational medicinal product (IMP) components or packaging.
- Patients with increased risks of bleeding or other complications from biopsies (e.g. patients under anticoagulation therapy for whom temporary discontinuation of this therapy cannot be safely performed).
- Patients with a known hypersensitivity or contraindication for iodinated contrast media (iCM) which cannot be controlled by taking prophylactic measures (e.g. temporary treatment interruption or introduction of adequate...
- Patients who cannot undergo PET/CT scanning (including but not limited to body size and claustrophobia).
- Any condition that in the opinion of the investigator may significantly interfere with study compliance (including but not limited to psychological or psychiatric, social or geographical condition potentially hampering...
The study team makes the final eligibility decision.
Where it's taking place
- Innsbruck, Tyrol, Austria
- Brussels, Brussels Capital, Belgium
- Aalst, East-Flanders, Belgium
- Leuven, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Innsbruck, Tyrol, Austria; Brussels, Brussels Capital, Belgium; Aalst, East-Flanders, Belgium; Leuven, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.