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Recruiting NCT07511933

Novel Ga68-PSMA PET/CT-tracer to Differentiate Between Radiation Necrosis and Tumor Progression in Brain Metastases

No phase Interventional Brain Metastases From Non-small Cell Lung Cancer (NSCLC) Brain Metastases From Melanoma Brain Metastases From Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 86-Gallium PSMA PET/CT.
Who it may be relevant to
Registry conditions: Brain Metastases From Non-small Cell Lung Cancer (NSCLC), Brain Metastases From Melanoma, Brain Metastases From Breast Cancer. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Novel Ga68-PSMA PET/CT-tracer to Differentiate Between Radiation Necrosis and Tumor Progression in Stereotactic Irradiated Brain Metastases: a Feasibility Study

Overview

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.

Interventions

  • 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)

Primary outcome measures

  • Tracer Uptake (SUVpeak) on PSMA PET/CT in Brain Lesions [Time frame: Baseline]
Secondary outcome measures (2)
  • Qualitative Visual Assessment of Brain Lesions on PSMA PET/CT [Time frame: Baseline]
  • Overall Visual Classification of Brain Lesions on PSMA PET/CT [Time frame: Baseline]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Netherlands · 1 center
  • Netherlands Cancer Institute - Antoni van Leeuwenhoek — Amsterdam

Identifiers

NCT: NCT07511933 · N18PET

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗