Evaluating a new imaging agent for brain metastasis in cancer patients
Evaluation of 68GaNOTA-Anti-HER2 VHH1 Uptake in Brain Metastasis of Cancer Patients
This study tests a new imaging agent to see how well it can help doctors spot brain metastases in cancer patients, regardless of whether their cancer is HER2-positive or HER2-negative.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitair Ziekenhuis Brussel Academic / other |
| Locations | 1 site (Brussels) |
| Trial ID | NCT03331601 on ClinicalTrials.gov |
What this trial studies
This study investigates how well the radiopharmaceutical 68-GaNOTA-Anti-HER2 VHH1 is taken up in brain metastases of cancer patients using PET/CT imaging. It includes patients with both HER2-positive and HER2-negative cancers, comparing the uptake in their brain lesions. Optional scans may be performed during or after treatment at specified time points to assess changes in uptake. The goal is to better understand the effectiveness of this imaging agent in detecting brain metastases.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with brain metastasized cancer and at least one measurable brain lesion.
Not a fit: Patients who are pregnant, breastfeeding, or have serious active infections or other life-threatening illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the detection and monitoring of brain metastases in cancer patients, leading to better treatment decisions.
How similar studies have performed: Other studies have shown promise in using targeted imaging agents for cancer detection, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Brussels
- Uz Brussel — Brussels, Belgium (Recruiting)
Study contacts
- Principal investigator: Tony Lahoutte, MD — Universitair Ziekenhuis Brussel
- Study coordinator: UZ Brussel
- Email: nucgmail@uzbrussel.be
- Phone: +3224776013
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.