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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorThe Netherlands Cancer Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent

Age ≥ 18 years old

WHO PS 0-3

Measurable lesion ≥10mm according to RANO BM

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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)

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Additional novel PET/CTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

Overall Visual Classification of Brain Lesions on PSMA PET/CT

Overall lesion classification based on combined qualitative visual assessment criteria.

Time frame
Baseline

Other outcomes

Sponsors and contacts

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