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Novel Ga68-PSMA PET/CT-tracer to Differentiate Between Radiation Necrosis and Tumor Progression in Brain Metastases

NCT07511933

RecruitingNA

Sponsor: The Netherlands Cancer Institute

Conditions: Brain Metastases From Non-small Cell Lung Cancer (NSCLC), Brain Metastases From Melanoma, Brain Metastases From Breast Cancer

Interventions: 86-Gallium PSMA PET/CT

Countries: Netherlands

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 overview

Sex: ALL

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

For all groups:

* Written informed consent
* Age ≥ 18 years old
* WHO PS 0-3
* Measurable lesion ≥10mm according to RANO BM

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:

* 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
* Pregnancy

Locations (1)

Amsterdam, Netherlands