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NCT Number: NCT07511933

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

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.

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Key information

Conditions

Brain Metastases From Non-small Cell Lung Cancer (NSCLC) Brain Diseases Brain Metastases From Breast Cancer Brain Metastases From Melanoma Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Netherlands Cancer Institute - Antoni van Leeuwenhoek

Amsterdam, 1066 CX Amsterdam, Netherlands

Location status: Recruiting

Location contact

Dieta Brandsma, MD, PhD

CONTACT

Lente Kroon, MD

CONTACT

[email protected]

0205129111

About this study

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:

  • newly diagnosed brain metastases,
  • definite radiation necrosis, and
  • diagnostic dilemma after radiotherapy.

The goals of this study are:

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Tracer Uptake (SUVpeak) on PSMA PET/CT in Brain Lesions

    Time frame: Baseline

    Quantitative tracer uptake (SUVpeak) measured on PSMA PET/CT in lesions classified as brain metastases, radiation necrosis, or diagnostic dilemma lesions.

Secondary outcomes

  1. Qualitative Visual Assessment of Brain Lesions on PSMA PET/CT

    Time frame: Baseline

    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.

  2. Overall Visual Classification of Brain Lesions on PSMA PET/CT

    Time frame: Baseline

    Overall lesion classification based on combined qualitative visual assessment criteria.

Study contacts

Contact information is provided by the study sponsor or research team.

Dieta Brandsma, MD, PhD

CONTACT

Lente Kroon, MD

CONTACT

[email protected]

0031205129111

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Apr 6, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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