RecruitingNot ApplicableNCT07511933

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.


Sponsor

The Netherlands Cancer Institute

Enrollment

100 participants

Start Date

Dec 24, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Inclusion Criteria11

  • 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 Criteria6

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIAGNOSTIC_TEST86-Gallium PSMA PET/CT

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


Locations(1)

Netherlands Cancer Institute - Antoni van Leeuwenhoek

Amsterdam, Netherlands

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07511933


Related Trials