Repeatability of 68-GaNOTA-Anti-HER2 VHH1 PET/CT in Breast Carcinoma Patients (VUBAR)
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Study objective: To quantify the uptake of 68GaNOTA-Anti-HER2 VHH1 in local or distant metastases from breast carcinoma patients and to assess repeatability of the image-based HER2 quantification. The uptake will be correlated to results obtained via biopsy of the same lesion, if available. Time schedule: After inclusion, patients will be injected intravenously with 37 - 185 MBq 68GaNOTA-Anti-HER2 VHH1 with a total mass of up to 200 μg NOTA-Anti-HER2 VHH1. Serum and plasma samples will be collected at injection. At 90 min after injection, a total body PET/CT scan will be performed. Patients will undergo a second PET/CT procedure, identical to the first procedure, within 8 days, with a minimal interval of 18h. Based on PET/CT images, up to 2 lesions will be selected for optional image-guided biopsy. Biopsy will be performed max. 28 days after the second PET/CT. Plasma and serum samples will be obtained between 60 and 365 days after first injection.
Condition or disease
Metastatic Breast CarcinomaLocally Advanced Breast Cancer
Repeatability of lesional PET/CT characteristics [ Time Frame: 90 min post injection ]
The lesional tracer uptake in local and distant metastases of at least 12 mm (for lymph nodes short axis) will be measured on both PET/CT's (expressed as standard uptake value (SUV) and repeatability will be calculated.
Secondary Outcome Measures :
Within-patient tumor heterogeneity for HER2 expression using PET/CT imaging [ Time Frame: 90 min post injection ]
Within-patient tumor heterogeneity for HER2 expression, observed on 68GaNOTA-Anti-HER2 VHH1 PET/CT or biopsy analyses
Immunogenicity [ Time Frame: prior to and between 60 and 365 days after the first injection ]
Immunogenicity assessed on plasma samples obtained prior to injection of the IMP and obtained between 60 and 365 days after the (first) injection
Histopathological results of biopsied lesions and correlation with PET/CT results [ Time Frame: max 28 days after the second PET/CT ]
semi-quantitative score of HER2 expression using immunohistochemistry performed on biopsied/resected tissues if available
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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