Novel Ga68-PSMA PET/CT-tracer to Differentiate Between Radiation Necrosis and Tumor Progression in Brain Metastases
Recruiting · NCT07511933 · Interventional (participants receive a specific treatment) · Lead sponsor: The Netherlands Cancer Institute
View the official record on ClinicalTrials.gov →Interventions studied
86-Gallium PSMA PET/CT
What this trial is about
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.
Who can take part
Age range
No age limits stated
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Netherlands Cancer Institute - Antoni van Leeuwenhoek - Amsterdam, Netherlands