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

Trial Title: Macrophage Imaging Using Ga-MMR-VHH2 in Lung Cancer Patients

NCT ID: NCT05933239

Condition: Non-small Cell Lung Cancer

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung

Conditions: Keywords:
PET/CT
MMR-PET/CT
Macrophage PET/CT
CD206

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: 68GaNOTA-Anti-MMR-VHH2
Description: Injection of the radiopharmaceutical and PET/CT imaging
Arm group label: Patients diagnosed with non-small cell lung cancer (NSCLC), planned for standard-of-care surgery

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Universitair Ziekenhuis Brussel

Address:
City: Jette
Zip: 1090
Country: Belgium

Status: Recruiting

Contact:
Last name: Tony Lahoutte, MD, PhD

Phone: +32 2 477 6013
Email: nucg.clinicaltrials@uzbrussel.be

Start date: March 30, 2023

Completion date: April 1, 2027

Lead sponsor:
Agency: Universitair Ziekenhuis Brussel
Agency class: Other

Source: Universitair Ziekenhuis Brussel

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05933239