Breast cancer
Conditions
Interventions
Product Name: 68GaNOTA-Anti-HER2 VHH1
Product Code: 68GaNOTA-Anti-HER2 VHH1
Pharmaceutical Form: Solution for injection
INN or Proposed INN: GALLIUM 68(68-GA)
Other descriptive name: GALLIUM 68(68-GA)
Sponsors
UZ Brussel
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Cohort 1 Patients will only be included in the study if they meet all of the following criteria: - Patient who has given informed consent - Patient with age 18 years or older - Patient with locally or distantly advanced breast carcinoma, with at least 1 lesion of at least 12 mm maximal diameter. For lymph node metastases, the largest diameter should be at least 15 mm and the short axis at least 12 mm. Cohort 2 Patients will only be included in the study if they meet all of the following criteria: - Patient who has given informed consent - Patient with age 18 years or older - Patient with locally advanced, unresectable, or metastatic cancer disease , with at least 1 lesion of at least 10 mm maximal diameter (For lymph node metastases, short axis at least 10 mm.) of any of the following types: breast carcinoma with low, intermediate or high HER2-expression, based on IHC 1+, or IHC 2+ or IHC 3+, as determined by local assessment on any of the available cancer tissues salivary gland cancer adenocarcinoma of the gastric body or gastro-esophageal junction endometrial cancer cancer of cervix uteri Non-small cell lung cancer biliary tract cancer including intra- or extrahepatic cholangiocarcinoma and tumors arising in the ampulla of Vater or gallbladder. pancreatic cancer colorectal cancer urothelial carcinoma, including transitional cell or predominantly transitional cell carcinoma of the renal pelvis, ureter, urinary bladder or urethra prostate cancer Other solid tumors with intermediate or high HER2-expression, based on IHC 2+ or IHC 3+, as determined by local assessment on any of the available cancer tissues -Patient who has progressed on or relapsed after a prior treatment regimen, according to the treating physician (based on all available data such as medical imaging, lab results, clinical examination, …), and who is considered for a next line of treatment -Patients who already participated in the trial and who are diagnosed with progressive or recurrent disease can be re-included if all inclusion criteria and none of the exclusion criteria apply. Cohort 3: Patients will only be included in the study if they meet all of the following criteria: - Patient who has given informed consent - Patient with age 18 years or older - Patient with local or locally advanced HER2-positive (either IHC 3+ and/or ISH positive) breast carcinoma, who is planned for neo-adjuvant treatment prior to surgery, and who is suspected for axillary lymph node invasion, based on clinical assessment, ultrasound, CT or MRI, or who has a confirmed lymph node invasion - Patients who either had 18F-FDG- PET/CT in the last 4 weeks before inclusion, or for whom 18F-FDG- PET/CT is planned before start of neoadjuvant treatment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: All cohorts: Patients will not be included in the study if one or more of the following criteria applies: -Patient is pregnant -Patient is breast feeding -Patient with recent (< 1 week) gastrointestinal disorders with diarrhea as major symptom -Patient with any serious active infection -Patient who has any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the test radiopharmaceutical -Patient who cannot communicate reliably with the investigator -Patient who is unlikely to cooperate with the requirements of the study -Patient who is unwilling and/or unable to give informed consent -Patient at increased risk of death from a pre-existing concurrent illness -Patient who participated already in this study. (cohort 1 and 3)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To determine repeatability of 68GaNOTA-Anti-HER2 VHH1 PET/CT on a lesional basis (cohort 1) - To report on uptake of 68GaNOTA-Anti-HER2 VHH1 in different cancer types that might overexpress HER2 (cohort 2) - To explore the feasibility and added value of 68GaNOTA-Anti-HER2 VHH1 in the neoadjuvant setting of HER2-expressing breast carcinoma (cohort 3) ;Secondary Objective: - To determine the optimal threshold uptake value for 68GaNOTA-Anti-HER2 VHH1 on PET/CT to distinguish HER2-positive from HER2-negative lesions (cohort 1). -To report on within-patient tumor heterogeneity for HER2 expression, observed on 68GaNOTA-Anti-HER2 VHH1 PET/CT or biopsy analyses (cohort 1 and 2). - To assess the immunogenicity of 68GaNOTA-Anti-HER2 VHH1 (cohort 1 and 2). -To determine in which relative number of patients, the patient management was altered after 68GaNOTA-Anti-HER2 VHH1 PET/CT and the subsequent optional biopsy (if performed) (cohort 2) ;Primary end point(s): The lesional tracer uptake in local and distant metastases will be assessed quantitatively using Standard Uptake Values (SUV) on PET acquisition data. Histopathological results of biopsied or surgically removed lesions will be interpreted using the existing international guidelines to determine HER2 status of lesions using both immunohistochemistry and in situ hybridization techniques. The histopathologiscal results will be correlated to lesional tracer uptake. For cohort 3, the presence of HER2-positive tumor cells will be correlated to tracer uptake in that lymph node before removal.;Timepoint(s) of evaluation of this end point: At the end of the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Within-patient tumor heterogeneity for HER2 expression, observed on 68GaNOTA-Anti-HER2 VHH1 PET/CT or biopsy analyses will be evaluated using the SUV on PET acquisition data and the histopathological results of biopsied lesions respectively. Immunogenicity will be assessed on plasma samples obtained prior to injection, prior to a second injection (if applicable; for patients in the repeatability substudy) and obtained between 90 and 365 days after the (first) injection. Anti-drug antibodies (ADA) will be measured and pre-existing as well as drug-induced ADA will be reported. ;Timepoint(s) of evaluation of this end point: At the end of the trial | — |
Countries
Belgium
Contacts
Public ContactMarleen Keyaerts
UZ Brussel
Outcome results
None listed