Novel Ga68-PSMA PET/CT-tracer to Differentiate Between Radiation Necrosis and Tumor Progression in Brain Metastases
1 other identifier
interventional
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 24, 2019
CompletedFirst Submitted
Initial submission to the registry
March 30, 2026
CompletedFirst Posted
Study publicly available on registry
April 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
July 24, 2026
July 1, 2026
7 years
March 30, 2026
July 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tracer Uptake (SUVpeak) on PSMA PET/CT in Brain Lesions
Quantitative tracer uptake (SUVpeak) measured on PSMA PET/CT in lesions classified as brain metastases, radiation necrosis, or diagnostic dilemma lesions.
Baseline
Secondary Outcomes (2)
Qualitative Visual Assessment of Brain Lesions on PSMA PET/CT
Baseline
Overall Visual Classification of Brain Lesions on PSMA PET/CT
Baseline
Study Arms (1)
Additional novel PET/CT
EXPERIMENTALAdditional novel PET/CT scan compared to standard-of-care
Interventions
PET/CT 45 minutes after intravenous administration of 100MBq Gallium-68 labelled PSMA-11 (\[68Ga\]Ga-PSMA-11)
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Netherlands Cancer Institute - Antoni van Leeuwenhoek
Amsterdam, 1066 CX Amsterdam, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dieta Brandsma, MD, PhD
Antoni van Leeuwenhoek Ziekenhuis
Central Study Contacts
Dieta Brandsma, MD, PhD
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2026
First Posted
April 6, 2026
Study Start
December 24, 2019
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
July 24, 2026
Record last verified: 2026-07