NCT04758650

Study of 68GaNOTA-Anti-MMR-VHH2 in Oncological Lesions, Cardiovascular Atherosclerosis, Syndrome With Abnormal Immune Activation and sarcoïdosis

Phase II Study to Evaluate the Clinical Potential of 68GaNOTA-Anti-MMR-VHH2 for in Vivo Imaging of MMR-expressing Macrophages by Means of Positron Emission Tomography (PET) in Oncological Lesions,Cardiovascular Atherosclerosis,Syndrome With Abnormal Immune Activation and sarcoïdosis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 oncological lesions in need of non-surgical therapy, patients with cardiovascular atherosclerosis, syndrome with abnormal immune activation and sarcoïdosis.

Conditions

• Solid Malignancy Located in the Head and Neck
• Cancer
• Carotid Stenosis
• Atherosclerosis of Artery
• Hodgkin Lymphoma, Adult
• Non Hodgkin Lymphoma
• HLH
• Cardiac Sarcoidosis
• Sarcoidosis

Interventions

Type	Name	Description
DRUG	68GaNOTA-Anti-MMR-VHH2	All subjects will receive at least one single intravenous injection of the IMP followed by a total body PET/CT prior to receiving standard-of-care therapy. For patients in cohorts 1 and 2 : an optional injection of the IMP during or after therapy can be administered if a patient is treated with non-surgical modalities. Patients in cohorts 6 and 7 who receive standard-of-care treatment can receive an optional injection of the IMP.

Timeline

• Start date: 2021-01-26
• Primary completion: 2025-01-26
• Completion: 2025-01-26
• First posted: 2021-02-17
• Last updated: 2023-11-18

Locations

1 site across 1 country: Belgium