Macrophage Imaging Using Ga-MMR-VHH2 in Lung Cancer Patients
ConditionNon-small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitair Ziekenhuis Brussel
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher
Pregnant patients
Breast feeding patients
Patients with any serious active infection
Trial design
Design model
Single group
Treatments tested in this trial
68GaNOTA-Anti-MMR-VHH2
DrugInjection of the radiopharmaceutical and PET/CT imaging
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Patients diagnosed with non-small cell lung cancer (NSCLC), planned for standard-of-care surgeryOther 1 intervention
Trial outcomes
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.
PET/CT and immunohistochemistry will be assessed using a (semi-)quantitative scale.
Time frame
Resection of lesion up to 21 days after PET/CTSponsors and contacts
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Source ClinicalTrials.gov