Clinical trial · Interventional
Novel Ga68-PSMA PET/CT-tracer to Differentiate Between Radiation Necrosis and Tumor Progression 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
NCT07511933CI-TRIAL-00119358recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases From Breast Cancer | — | UNRESOLVED | — |
| Brain Metastases From Melanoma | — | UNRESOLVED | — |
| Brain Metastases From Non-small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 86-Gallium PSMA PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Additional novel PET/CT
- description
- Additional novel PET/CT scan compared to standard-of-care
- interventionNames
- Diagnostic Test: 86-Gallium PSMA PET/CT
Primary outcomes (1)
- measure
- Tracer Uptake (SUVpeak) on PSMA PET/CT in Brain Lesions
- timeFrame
- Baseline
- description
- Quantitative tracer uptake (SUVpeak) measured on PSMA PET/CT in lesions classified as brain metastases, radiation necrosis, or diagnostic dilemma lesions.
Secondary outcomes (2)
- measure
- Qualitative Visual Assessment of Brain Lesions on PSMA PET/CT
- timeFrame
- Baseline
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.