RecruitingPhase 2NCT05933239

Macrophage Imaging Using Ga-MMR-VHH2 in Lung Cancer Patients

A Phase II Study to Evaluate the Imaging Potential of 68GaNOTA-Anti-MMR VHH2 for in Vivo Imaging of MMR-expressing Macrophages by Means of Positron Emission Tomography (PET) in Patients With Non-small Cell Lung Cancer (NSCLC)


Sponsor

Universitair Ziekenhuis Brussel

Enrollment

20 participants

Start Date

Mar 30, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Phase II study to evaluate the clinical potential of 68GaNOTA-anti-MMR-VHH2 for in vivo imaging of Macrophage Mannose Receptor (MMR)-expressing Macrophages by means of Positron Emission Tomography (PET) in patients with non-small cell lung cancer (NSCLC) planned for surgical resection.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Patients who have given informed consent
  • Patients at least 18 years old
  • Patient with local, locally advanced or metastatic disease of non-small cell lung cancer, who is planned for resection or surgical biopsy of at least one lesion. In order to minimise partial volume effect, the diameter of the tumour to be resected or biopsied should be ≥ 10 mm in short axis for invaded adenopathies and ≥ 10 mm in long axis for all other types of lesions

Exclusion Criteria8

  • Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher
  • Pregnant patients
  • Breast feeding patients
  • Patients with any serious active infection
  • Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test radiopharmaceutical
  • Patients who are unlikely to cooperate with the requirements of the study
  • Patients who are unwilling and/or unable to give informed consent
  • Patients at increased risk of death from a pre-existing concurrent illness

Interventions

DRUG68GaNOTA-Anti-MMR-VHH2

Injection of the radiopharmaceutical and PET/CT imaging


Locations(1)

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, Belgium

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NCT05933239


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