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

Universitair Ziekenhuis Brussel

Status and phase

Enrolling

Phase 2

Conditions

Receptor, ErbB-2

Carcinoma

Treatments

Drug: 68GaNOTA-Anti-HER2 VHH1

Study type

Interventional

Funder types

Other

Identifiers

NCT03331601

2015-002328-24 (EudraCT Number)

UZBRU_VHH1_2

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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