Repeatability of 68-GaNOTA-Anti-HER2 VHH1 PET/CT in Breast Carcinoma Patients
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 2
Details
Lead Sponsor:
Universitair Ziekenhuis Brussel
Collaborators:
Agentschap voor Innovatie door Wetenschap en Technologie, Project Toegepast Biomedisch onderzoek met een primair Maatschappelijke finaliteit. Kom Op Tegen Kanker Kom op tegen Kanker (Stand-up-to-Cancer), the Flemish cancer society