Novel Ga68-PSMA PET/CT-tracer to Differentiate Between Radiation Necrosis and Tumor Progression i… (NCT07511933) | Clinical Trial Compass
RecruitingNot Applicable
Novel Ga68-PSMA PET/CT-tracer to Differentiate Between Radiation Necrosis and Tumor Progression in Brain Metastases
Netherlands100 participantsStarted 2019-12-24
Plain-language summary
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 participate
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Tracer Uptake (SUVpeak) on PSMA PET/CT in Brain Lesions