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Clinical Trial · NCT05933239
Macrophage Imaging Using Ga-MMR-VHH2 in Lung Cancer Patients
Overview
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.
Sponsor
Unknown Organization
Phase
Phase 2
Contacts
UZ Brussel (CONTACT)
nucg.clinicaltrials@uzbrussel.be
+32 2 477 6013
Tony Lahoutte, MD, PhD (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT05933239Drug / Compound
NOTA-Anti-MMR-VHH2
Isotope(s):
GALLIUM-68
Radioisotope: Ga-68
Theranostic Role: PET Imaging
T1/2 (Half-Life): 68 minutes
Decay Mode: POSITRON β+ (88.9%), GAMMA, ELECTRON CAPTURE (8.7%)
Energy: Beta: max 1.9 MeV Gamma 1.1 MeV, 511 keV
Range: N/A
Decay Daughters: Zn68 (Stable)
Status: FDA Approvals: NETSPOT® (2016), LOCAMETZ® (2022), ILLUCIX® (2021)
Target(s):
- Mannose Receptor (CD206/MRC1)
Ligand Class: Small Proteins and Antibody Fragments
Chelator: NOTA
Eligibility
Inclusion
- * Patients who have given informed consent
- Patients at least 18 years old
- 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.
- 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
- 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
- * Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher
- Pregnant patients
- Breast feeding patients
- Patients with any serious active infection
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