Clinical Trial · NCT03331601

Evaluation of 68-GaNOTA-Anti-HER2 VHH1 Uptake in Brain Metastasis of Cancer Patients

Overview

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 and the uptake in their lesions will be compared. Optional 68-GaNOTA-Anti-HER2 VHH1 scans may be performed during or after treatment, at time points 12±6 weeks and 24±9 weeks after the first scan.

Sponsor

Unknown Organization

Phase

Phase 2

Contacts

Tony Lahoutte, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03331601

Drug / Compound

NOTA-Anti-HER2 VHH1

Isotope(s):

Target(s):

HER2

Ligand Class: Small Proteins and Antibody Fragments

Chelator: NOTA

Eligibility

Inclusion

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 who have given informed consent
Age 18 years or older
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

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 with recent (\< 1 week) gastrointestinal disorders with diarrhea as major symptom
Breast feeding patients
* Pregnant patients