Ga68-PSMA PET/CT to tell radiation damage from tumor growth in brain metastases
Novel Ga68-PSMA PET/CT-tracer to Differentiate Between Radiation Necrosis and Tumor Progression in Stereotactic Irradiated Brain Metastases. A Feasibility Study.
This project will test whether a Ga68-PSMA PET/CT scan can tell radiation necrosis apart from tumor regrowth in adults with brain metastases from lung cancer, melanoma, or breast cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | The Netherlands Cancer Institute Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT07511933 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with measurable (≥10 mm) brain metastases from NSCLC, melanoma, or breast cancer who are either newly diagnosed, have confirmed radiation necrosis at a previously SRT-treated site (>9 months after SRT), or present a post-radiotherapy diagnostic dilemma, with WHO performance status 0–3 and able to give informed consent.
Not a fit: Patients with lesions under 10 mm, a known allergy to Ga68-PSMA, recent seizures (<7 days), lesions from other primary cancers, or those unable to travel to the study site are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this imaging could help doctors avoid unnecessary surgery or change treatment by distinguishing radiation necrosis from tumor regrowth more accurately.
How similar studies have performed: PSMA-PET is well established in prostate cancer and early reports show PSMA uptake in some non-prostatic brain metastases and radiation necrosis, so this use is relatively novel but supported by encouraging preliminary data.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amsterdam
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.