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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: 68GaNOTA-Anti-MMR-VHH2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have given informed consent Patients at least 18 years old Patient with local, locally advanced or metastatic disease of 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients diagnosed with non-small cell lung cancer (NSCLC), planned for standard-of-care surgery<br> | Drug: 68GaNOTA-Anti-MMR-VHH2<br>* Injection of the radiopharmaceutical and PET/CT imaging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PET/CT, MMR-PET/CT, Macrophage PET/CT, CD206