BridgeMD
Evaluating the Diagnostic Performance of Human Epidermal Growth Factor Receptor 2 (HER2) targeted Positron Emission Tomography and Computed Tomography (PET/CT) with 68Ga-ABS011 in metastatic Breast Cancer (mBC) and other metastatic solid carcinomas.
EU CTIS ID: 2024-511419-22-00
What this study is testing
To evaluate the diagnostic performance of 68Ga-ABS011 PET/CT compared to the standard of care IHC (and ISH) HER2 status test (all indications).
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Adult (≥ 18 years at the time of informed consent signature) male or female patient
- 2. Patient with confirmed de novo or pre-treated mBC (multiple previous treatment lines in metastatic setting are allowed).
- 3. Patients with documented hormone receptor positive/HER2 negative, triple-negative or HER2 positive mBC that could become eligible for commercially available HER2 targeted monotherapy (i.e. through confirmation of HER2 IHC non-0 status assessed during the course of the study).
- 4. 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).
- 5. Patient willing to undergo at least one tumor biopsy.
- 6. 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.
You likely can't join if
- 1. Primary (non-metastatic) breast cancer.
- 6. Life expectancy lower than 3 months.
- 7. Pregnancy or breastfeeding.
- 8. Inadequate organ function, suggested by clinically relevant abnormal laboratory results: a. Significantly impaired renal function defined as estimated GFR <30 ml/min/1.73m2. b. Total bilirubin ≤1.5 x Upper Limit of Normal (ULN) (unless the patient has documented Gilbert's syndrome). c. Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or Alanine aminotransferase (ALT)/ serum glutamic pyruvic transaminase (SGPT) >5.0 x ULN.
- 9. Patients with a known hypersensitivity to any of the IMP components or packaging.
- Same exclusion criteria are applicable for (non-BC) metastatic solid carcinoma subjects, except for exclusion# 3: no 18F-FDG PET/ceCT must be completed as part of the screening visit. A recent historical 18F-FDG PET/(ce)CT scan performed as per standard of care may also be used to support eligibility assessment, provided it is not older than 1 month prior to screening. If no such scan is available within this timeframe, a new scan should be performed as part of standard of care.
See the full eligibility criteria
Who can join
- 1. Adult (≥ 18 years at the time of informed consent signature) male or female patient
- 2. Patient with confirmed de novo or pre-treated mBC (multiple previous treatment lines in metastatic setting are allowed).
- 3. Patients with documented hormone receptor positive/HER2 negative, triple-negative or HER2 positive mBC that could become eligible for commercially available HER2 targeted monotherapy (i.e. through confirmation of HER2 IHC non-0 status assessed during the course of the study).
- 4. 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).
- 5. Patient willing to undergo at least one tumor biopsy.
- 6. 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.
- 7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2.
- 8. Ability and willingness of the research participant to provide written informed consent.
- Same inclusion criteria are applicable for (non-BC) metastatic solid carcinoma subjects, with the difference that a recent historical 18F-FDG PET/(ce)CT scan performed as per standard of care may also be used to support eligibility assessment, provided it is not older than 1 month prior to screening. If no such scan is available within this timeframe, a new scan should be performed as part of standard of care.
What rules you out
- 1. Primary (non-metastatic) breast cancer.
- 6. Life expectancy lower than 3 months.
- 7. Pregnancy or breastfeeding.
- 8. Inadequate organ function, suggested by clinically relevant abnormal laboratory results: a. Significantly impaired renal function defined as estimated GFR <30 ml/min/1.73m2. b. Total bilirubin ≤1.5 x Upper Limit of Normal (ULN) (unless the patient has documented Gilbert's syndrome). c. Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or Alanine aminotransferase (ALT)/ serum glutamic pyruvic transaminase (SGPT) >5.0 x ULN.
- 9. Patients with a known hypersensitivity to any of the IMP components or packaging.
- Same exclusion criteria are applicable for (non-BC) metastatic solid carcinoma subjects, except for exclusion# 3: no 18F-FDG PET/ceCT must be completed as part of the screening visit. A recent historical 18F-FDG PET/(ce)CT scan performed as per standard of care may also be used to support eligibility assessment, provided it is not older than 1 month prior to screening. If no such scan is available within this timeframe, a new scan should be performed as part of standard of care.
- 10. 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).
- 11. 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 pre-medication).
- 12. Patients who cannot undergo PET/CT scanning (including but not limited to body size and claustrophobia).
- 13. 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 compliance with the study requirements).
- 2. Patient not willing to undergo at least one tumor biopsy.
- 3. 18F-FDG PET/ceCT completed before screening and patient not willing to repeat this assessment.
- 4. 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.
- 5. Brain and liver metastases are the sole sites of metastatic disease.
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.