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NCT Number: NCT05933239

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, 1090, Belgium

Location status: Recruiting

Location contact

Tony Lahoutte, MD, PhD

CONTACT

[email protected]

+32 2 477 6013

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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
  • Patients who participated already in this study can be included if the subject meets all of the inclusion and none of the exclusion criteria at time of second inclusion.

Exclusion criteria

  • 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

Treatment and study plan

68GaNOTA-Anti-MMR-VHH2

Drug

Injection of the radiopharmaceutical and PET/CT imaging

Primary outcomes

  1. Correlation of uptake of 68GaNOTA-Anti-MMR-VHH2 in a NSCLC lesion before surgery with the immunohistological MMR-staining of the excised lesion.

    Time frame: Resection of lesion up to 21 days after PET/CT

    PET/CT and immunohistochemistry will be assessed using a (semi-)quantitative scale.

Study contacts

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

UZ Brussel

CONTACT

[email protected]

+32 2 477 6013

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

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)

Acronym: MAGMA

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 6, 2023
Registry last updated
Jun 1, 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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