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

Phase 2

Recruiting

• Conditions: Hodgkin Lymphoma, Adult; Non Hodgkin Lymphoma; Solid Malignancy Located in the Head and Neck; Cancer; Atherosclerosis of Artery; Cardiac Sarcoidosis; Sarcoidosis; Carotid Stenosis; HLH
• Interventions: Drug: 68GaNOTA-Anti-MMR-VHH2

• Registration Number: NCT04758650
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-26
• Study First Submitted: 2021-02-12
• Study First Submitted QC: 2021-02-12
• Study First Posted: 2021-02-17
• Status Verified: 2023-10
• Last Update Submitted: 2023-11-16
• Last Update Posted: 2023-11-18
• Primary Completion: 2025-01-26
• Study Completion: 2025-01-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cancer, lymphoma, carotid plaque, patients suspected for HLH, sarcoidosis	68GaNOTA-Anti-MMR-VHH2	Cohort 1: Patients diagnosed with pathology malignancies of the head and neck Cohort 2: Patients diagnosed with any malignancy with a solid component Cohort 3: Patients diagnosed with carotid plaque, planned for SOC carotid endarterectomy Cohort 4: Patients with a biopsy-proven Hodgkin or non-Hodgkin lymphoma Cohort 5: Patients suspected for HLH, planned for (SOC) bone marrow in case it is not done before Cohort 6 : Patients with endomyocardial biopsy proven or suspected cardiac sarcoïdosis Cohort 7 : Patients with biopsy-proven sarcoïdosis

Primary Outcome Measures

Name	Time	Method
Correlation of IMP uptake before start of treatment in malignant lesions of the head and neck with either treatment response during or after radiotherapy or systemic treatment, or with immunohistological MMR-staining in patients with surgical treatment	up to 5 years	Uptake will be measured in cancer lesions on PET/CT 1. Treatment response will be evaluated by assessing time to treatment failure and by assessment of status of patients for treatment failure (Y/N) at 6 and 12 months after start of treatment or immunological MMR staining
To investigate the uptake of 68GaNOTA-Anti-MMR-VHH2 in cardiac sarcoidosis on PET/CT in patients with endomyocardial biopsy proven or suspected cardiac sarcoidosis (cohort 6)	up to 5 years	Uptake in lesions with known or suspected cardiac sarcoidosis on MMR-PET/CT on PET/CT1
Correlation of uptake of 68GaNOTA-Anti-MMR-VHH2 before start of treatment in solid cancer lesions with time to treatment failure after systemic treatment with immune checkpoint inhibition, either or not combined with other systemic therapies. (cohort 2)	up to 5 years	Uptake will be measured in cancer lesions on PET/CT 1. Treatment response will be evaluated by assessing time to treatment failure and by assessment of status of patients for treatment failure (Y/N) at 6 months and 12 months after start of treatment
Correlation of uptake of 68GaNOTA-Anti-MMR-VHH2 in atherosclerotic carotid plaques before surgery with the immunohistological MMR-staining of the excised atherosclerotic carotid plaque.(cohort 3)	Resection of lesion up to 21 days after PET/CT	Uptake in excised atherosclerotic plaque on PET/CT 1. Immunohistological MMR staining of excised atherosclerotic plaque, scored visually by interpreter
Correlation of uptake of 68GaNOTA-Anti-MMR-VHH2 in central bone on PET/CT with the presence of hemophagocytosis in bone marrow samples, and the presence of clinical risk factors (cohort 5).	up to 5 years	Uptake in bone marrow on MMR-PET/CT 1. Bone marrow aspirate or trephine biopsy, scored individually by interpreter. Results of additional blood sample analysis to determine clinical risk factor
Correlation of uptake of 68GaNOTA-Anti-MMR-VHH2 in lymphoma-related lesions before start of treatment in Hodgkin and non-Hodgkin lymphoma patients (cohort 4).	up to 5 years	Uptake will be measured in lymphoma-related lesions on MMR-PET/CT 1
To investigate the uptake of 68GaNOTA-Anti-MMR-VHH2 in sarcoidosis on PET/CT in patients with biopsy-proven sarcoidosis (cohort 7)	up to 5 years	Uptake in lesions involved with sarcoidosis on MMR-PET/CT

Trial Locations

Locations (1)

Uz Brussel; 🇧🇪 Brussels, Brussel, Belgium