Ga68-PSMA PET/CT to tell radiation damage from tumor growth in brain metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective phase II diagnostic feasibility project conducted at a single center that uses Ga68-PSMA PET/CT imaging in adults with stereotactically treated or newly diagnosed brain metastases from NSCLC, melanoma, or breast cancer. Participants are enrolled into three predefined cohorts per primary tumor type: newly diagnosed metastases, definite radiation necrosis (>9 months after stereotactic radiotherapy), and cases with a diagnostic dilemma after radiotherapy. Eligible patients must have measurable lesions ≥10 mm and undergo Ga68-PSMA PET/CT with quantification of PSMA uptake. The main goals are to describe PSMA expression in these lesions and to see if quantified PSMA activity can distinguish tumor progression from radiation necrosis when compared with clinical follow-up or histology.

Why it matters

Who can join: the full rules

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's running

• Netherlands Cancer Institute - Antoni van Leeuwenhoek
  Amsterdam, Netherlands Recruiting

Study contacts

• Principal investigator: Dieta Brandsma, MD, PhD — Antoni van Leeuwenhoek Ziekenhuis
• Study coordinator: Lente Kroon, MD
• Email: neurologie@nki.nl
• Phone: 0031205129111

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.