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

Non-small Cell Lung Cancer Clinical Trial

— MAGMA  

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05933239
• Other study ID #: UZBRU_VHH2_4
• Status: Recruiting
• Phase: Phase 2
• Start date: March 30, 2023
• Est. completion date: April 1, 2027

Study information

• Verified date: June 2024
• Source: Universitair Ziekenhuis Brussel
• Contact: UZ Brussel
• Phone: +32 2 477 6013
• Email: nucg.clinicaltrials[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 1, 2027
• Est. primary completion date: April 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• 68GaNOTA-Anti-MMR-VHH2
Injection of the radiopharmaceutical and PET/CT imaging

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Jette	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of uptake of 68GaNOTA-Anti-MMR-VHH2 in a NSCLC lesion before surgery with the immunohistological MMR-staining of the excised lesion.	PET/CT and immunohistochemistry will be assessed using a (semi-)quantitative scale.	Resection of lesion up to 21 days after PET/CT