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

Phase 2

Recruiting

• Conditions: Carcinoma; Receptor, ErbB-2

• Registration Number: NCT03331601
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-16
• Study First Submitted: 2017-10-24
• Study First Submitted QC: 2017-10-31
• Study First Posted: 2017-11-06
• Status Verified: 2024-02
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24
• Primary Completion: 2026-09
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The tumor targeting potential in brain metastasis	90 min post injection	The tumor targeting potential in brain metastasis will be assessed quantitatively using Standard Uptake Values (SUV) by an experienced nuclear medicine physician, unaware of the HER2-status.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Uz Brussel; 🇧🇪 Brussels, Belgium