Recruiting
Novel Ga68-PSMA PET/CT-tracer to Differentiate Between Radiation Necrosis and Tumor Progression in Brain Metastases
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.
ClinicalTrials.gov IDNCT07511933
PhaseNA
Enrollment100
SponsorThe Netherlands Cancer Institute
AgeNo minimum reported
SexALL
Conditions studied
Brain Metastases From Non-small Cell Lung Cancer (NSCLC), Brain Metastases From Melanoma, Brain Metastases From Breast Cancer
About this study
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.
Interventions
- 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)
Primary outcomes
- Tracer Uptake (SUVpeak) on PSMA PET/CT in Brain Lesions (Baseline)
Eligibility information
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
Study locations
- Netherlands Cancer Institute - Antoni van Leeuwenhoek, Amsterdam, 1066 CX Amsterdam Netherlands
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.