Overview

Repeatability of 68-GaNOTA-Anti-HER2 VHH1 PET/CT in Breast Carcinoma Patients

Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
0
Participant gender:
All
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
Accepts Healthy Volunteers?
No
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
Criteria
Inclusion Criteria:

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.

Exclusion Criteria:

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.