Trials / Recruiting
RecruitingNCT07511933
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.
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- The Netherlands Cancer Institute · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Detailed description
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: 1. newly diagnosed brain metastases, 2. definite radiation necrosis, and 3. diagnostic dilemma after radiotherapy. 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.
Conditions
- Brain Metastases From Non-small Cell Lung Cancer (NSCLC)
- Brain Metastases From Melanoma
- Brain Metastases From Breast Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | 86-Gallium PSMA PET/CT | PET/CT 45 minutes after intravenous administration of 100MBq Gallium-68 labelled PSMA-11 (\[68Ga\]Ga-PSMA-11) |
Timeline
- Start date
- 2019-12-24
- Primary completion
- 2027-01-01
- Completion
- 2027-07-01
- First posted
- 2026-04-06
- Last updated
- 2026-04-06
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT07511933. Inclusion in this directory is not an endorsement.