Status:
RECRUITING
Evaluation of 68-GaNOTA-Anti-HER2 VHH1 Uptake in Brain Metastasis of Cancer Patients
Lead Sponsor:
Universitair Ziekenhuis Brussel
Conditions:
Carcinoma
Receptor, ErbB-2
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study investigates the uptake of the radiopharmaceutical 68-GaNOTA-Anti-HER2 VHH1 in brain metastasis using PET/CT imaging. Patients with HER2-positive and HER2-negative cancer will be included a...
Eligibility Criteria
Inclusion
- Patients who have given informed consent
- Age 18 years or older
- Patients with brain metastasized cancer, with at least 1 brain lesion of at least 8 mm maximal diameter, as measured by CT or MRI.
- Patients with potentially HER2-positive cancer. Either a HER2 staining should have been done in standard of care, or sufficient tissue should be available for HER2-staining for study purpose.
Exclusion
- Pregnant patients
- Breast feeding patients
- Patients with recent (\< 1 week) gastrointestinal disorders with diarrhea as major symptom
- Patients with any serious active infection
- Patients who have 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
- Patients who cannot communicate reliably with the investigator
- Patients at increased risk of death from a pre-existing concurrent illness
Key Trial Info
Start Date :
October 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03331601
Start Date
October 16 2017
End Date
December 1 2026
Last Update
April 24 2024
Active Locations (1)
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1
Uz Brussel
Brussels, Belgium, 1090