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

N/ARecruitingNCT07511933

The Netherlands Cancer Institute100 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

100

Conditions

Brain Metastases From Non-small Cell Lung Cancer (NSCLC)Brain Metastases From Melanoma Brain Metastases From Breast Cancer

Interventions

86-Gallium PSMA PET/CTDIAGNOSTIC_TEST

PET/CT 45 minutes after intravenous administration of 100MBq Gallium-68 labelled PSMA-11 (\[68Ga\]Ga-PSMA-11)

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Netherlands Cancer Institute - Antoni van Leeuwenhoek

Amsterdam, Netherlands

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Baseline

Secondary Outcomes

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.

Time frame: Baseline

Overall Visual Classification of Brain Lesions on PSMA PET/CT

Overall lesion classification based on combined qualitative visual assessment criteria.

Time frame: Baseline

Central Contacts

Lente Kroon, MD

CONTACT

0031205129111 neurologie@nki.nl

Dieta Brandsma, MD, PhD

CONTACT

Data from ClinicalTrials.gov

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