Evaluation of 68GaNOTA-Anti-HER2 VHH1 uptake in brain metastasis of cancer patients

Phase 2

Recruiting

• Conditions: Cancer patients with brain metastasis

• Registration Number: 2024-513997-23-00
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

To compare the uptake of 68GaNOTA-Anti-HER2 VHH1 in brain metastasis lesions from HER2-positive and HER2-negative patients

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-07-30
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• 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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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		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
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.		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
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.		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; 🇧🇪 Jette, Belgium

UZ Brussel

🇧🇪Jette, Belgium

Tony Lahoutte

Site contact

024775020

nucg.clinicaltrials@uzbrussel.be