An interventional study of 86-Gallium PSMA PET/CT in Brain Metastases From Non-small Cell Lung Cancer (NSCLC), Brain Metastases From Melanoma and Brain Metastases From Breast Cancer, sponsored by The Netherlands Cancer Institute. Recruiting at 1 site in Netherlands. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by The Netherlands Cancer Institute · Not applicable, Interventional, and Diagnostic
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.
This prospective phase II diagnostic feasibility study investigates the diagnostic potential of 68-Gallium PSMA-PET/CT in stereotactic irradiated brain metastases from non-small cell lung cancer, melanoma and breast cancer.
Participants will be enrolled in three predefined cohorts per primary tumor type:
The goals of this study are:
1. Evaluating PSMA expression using Ga68-PSMA PET/CT in brain metastases of NSCLC, breast cancer and melanoma patients eligible for stereotactic radiotherapy (SRT) or surgery. 2. Evaluating PSMA expression using Ga68-PSMA PET/CT in patients with definite radiation necrosis. 3. Evaluating the use of Ga68-PSMA PET/CT to differentiate progressive brain metastases of NSCLC, breast cancer and/ or melanoma from radiation necrosis by quantifying PSMA activity.
For all groups:
For brain metastases groups:
- newly diagnosed brain metastases from either NSCLC (group 1) or melanoma (group 2) or breast cancer (group 7).
For radiation necrosis groups:
- Brain lesion at the location of a formerly brain metastases that has been treated with SRT (> 9 months ago), with the definite diagnosis of radiation necrosis at the location of formerly SRT-treated brain metastases of NSCLC (group 3), melanoma (group 4) and/ or breast cancer (group 8).
For diagnostic dilemma groups:
- Brain lesion at the location of a formerly brain metastases with a diagnostic dilemma of radiation necrosis and recurrent brain metastases of NSCLC (group 5), melanoma (group 6) and/ or breast cancer (group 9).
Exclusion Criteria:
For all groups:
Additional novel PET/CT scan compared to standard-of-care
Diagnostic Test: 86-Gallium PSMA PET/CT
PET/CT 45 minutes after intravenous administration of 100MBq Gallium-68 labelled PSMA-11 (\[68Ga\]Ga-PSMA-11)
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.
Time frame: Baseline
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.
Time frame: Baseline
Overall Visual Classification of Brain Lesions on PSMA PET/CT
Overall lesion classification based on combined qualitative visual assessment criteria.
Time frame: Baseline
Plan to share: Undecided
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The Netherlands Cancer Institute