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

RECRUITINGPhase 2Sponsored by Universitair Ziekenhuis Brussel
Actively Recruiting
PhasePhase 2
SponsorUniversitair Ziekenhuis Brussel
Started2017-10-16
Est. completion2026-09
Eligibility
Age18 Years+
Healthy vol.Accepted

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions3

CancerCarcinomaReceptor, ErbB-2

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