Carcinoma, Receptor, ErbB-2
Conditions
Keywords
Brain metastasis, HER2
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 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.
Interventions
Injection of the radiopharmaceutical and PET/CT 90 min post injection
Sponsors
Universitair Ziekenhuis Brussel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The tumor targeting potential in brain metastasis | 90 min post injection | The tumor targeting potential in brain metastasis will be visually scored as positive or negative by an experienced nuclear medicine physician, unaware of the HER2-status. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in uptake in brain lesions evaluated by PET/CT scan during or after treatment | up to 2 years after inclusion | If available, uptake will be evaluated during and after treatment and compared to baseline values. Results will be compared to information of patient's disease course |
Countries
Belgium
Contacts
PRINCIPAL_INVESTIGATORTony Lahoutte, MD
Universitair Ziekenhuis Brussel
Outcome results
None listed