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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.
This prospective phase II diagnostic feasibility study investigates the diagnostic potential of 68-Gallium PSMA-PET/CT in stereotactic irradiated brain metastases from non-small cell lung cancer, melanoma and breast cancer.
Participants will be enrolled in three predefined cohorts per primary tumor type:
The goals of this study are:
1. Evaluating PSMA expression using Ga68-PSMA PET/CT in brain metastases of NSCLC, breast cancer and melanoma patients eligible for stereotactic radiotherapy (SRT) or surgery. 2. Evaluating PSMA expression using Ga68-PSMA PET/CT in patients with definite radiation necrosis. 3. Evaluating the use of Ga68-PSMA PET/CT to differentiate progressive brain metastases of NSCLC, breast cancer and/ or melanoma from radiation necrosis by quantifying PSMA activity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Additional novel PET/CT | Experimental | Additional novel PET/CT scan compared to standard-of-care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 86-Gallium PSMA PET/CT | Diagnostic Test | PET/CT 45 minutes after intravenous administration of 100MBq Gallium-68 labelled PSMA-11 ([68Ga]Ga-PSMA-11) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative Visual Assessment of Brain Lesions on PSMA PET/CT | Qualitative visual assessment of lesions classified as brain metastases, radiation necrosis, or diagnostic dilemma lesions on PSMA PET/CT based on lesion shape (round to spiculated), lesion margin (sharp to ill-defined), internal homogeneity (homogeneous to heterogeneous), each scored on a 5-point Likert scale; multifocality and presence of central photopenia, both scored as yes/no. |
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Inclusion Criteria:
For all groups:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lente Kroon, MD | Contact | 0031205129111 | neurologie@nki.nl | |
| Dieta Brandsma, MD, PhD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Dieta Brandsma, MD, PhD | Antoni van Leeuwenhoek Ziekenhuis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Netherlands Cancer Institute - Antoni van Leeuwenhoek | Recruiting | Amsterdam | 1066 CX Amsterdam | Netherlands |
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| Baseline |
| Overall Visual Classification of Brain Lesions on PSMA PET/CT | Overall lesion classification based on combined qualitative visual assessment criteria. | Baseline |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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