About this trial
This study aims to evaluate the diagnostic potential of 68-Gallium PSMA-PET/CT in stereotactic irradiated brain metastases from non-small cell lung cancer, melanoma and breast cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent
Age ≥ 18 years old
WHO PS 0-3
Measurable lesion ≥10mm according to RANO BM
Disqualifiers
Known allergy to Ga68-PSMA
Epileptic seizure less than 7 days before Ga68-PSMA PET/CT scan
Life expectancy less than 3 months
Patients with known prostate carcinoma
Trial design
Single group
Treatments tested in this trial
86-Gallium PSMA PET/CT
Diagnostic testPET/CT 45 minutes after intravenous administration of 100MBq Gallium-68 labelled PSMA-11 (\[68Ga\]Ga-PSMA-11)
Treatment groups
Trial outcomes
Primary outcomes
Tracer Uptake (SUVpeak) on PSMA PET/CT in Brain Lesions
Quantitative tracer uptake (SUVpeak) measured on PSMA PET/CT in lesions classified as brain metastases, radiation necrosis, or diagnostic dilemma lesions.
Secondary outcomes
Qualitative Visual Assessment of Brain Lesions on PSMA PET/CT
Qualitative visual assessment of lesions classified as brain metastases, radiation necrosis, or diagnostic dilemma lesions on PSMA PET/CT based on lesion shape (round to spiculated), lesion margin (sharp to ill-defined), internal homogeneity (homogeneous to heterogeneous), each scored on a 5-point Likert scale; multifocality and presence of central photopenia, both scored as yes/no.
Overall Visual Classification of Brain Lesions on PSMA PET/CT
Overall lesion classification based on combined qualitative visual assessment criteria.
Sponsors and contacts
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