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

NCT04758650 | Unknown Phase 2 DMC

• 2 other identifiers: UZBRU_VHH2_22020-002483-31
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (7)

• 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

  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

  up to 5 years

• 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)

  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

  up to 5 years

• 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)

  Uptake in excised atherosclerotic plaque on PET/CT 1. Immunohistological MMR staining of excised atherosclerotic plaque, scored visually by interpreter

  Resection of lesion up to 21 days after PET/CT

• 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).

  Uptake will be measured in lymphoma-related lesions on MMR-PET/CT 1

  up to 5 years

• 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).

  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

  up to 5 years

• 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)

  Uptake in lesions with known or suspected cardiac sarcoidosis on MMR-PET/CT on PET/CT1

  up to 5 years

• To investigate the uptake of 68GaNOTA-Anti-MMR-VHH2 in sarcoidosis on PET/CT in patients with biopsy-proven sarcoidosis (cohort 7)

  Uptake in lesions involved with sarcoidosis on MMR-PET/CT

  up to 5 years

Study Arms (1)

Cancer, lymphoma, carotid plaque, patients suspected for HLH, sarcoidosis

EXPERIMENTAL

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

Drug: 68GaNOTA-Anti-MMR-VHH2

Interventions

68GaNOTA-Anti-MMR-VHH2 DRUG

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.

Also known as: MMR-PET/CT

Cancer, lymphoma, carotid plaque, patients suspected for HLH, sarcoidosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COHORT 1:
• \- Patients who have given informed consent
• \- Patients at least 18 years old
• \- Patients with : A) biopsy-proven solid malignancy located in the head and neck, independent of tumour stage or pathological subtype, or B) suspected malignancy in the head and neck, planned for biopsy
• In order to minimize partial volume effect, the diameter of at least 1 tumour lesion should be ≥ 10 mm in short axis for invaded adenopathies and ≥ 10 mm in long axis for all other types of lesions.

You may not qualify if:

• COHORT 2:
• Patients who have given informed consent
• Patients at least 18 years old
• Patient with a biopsy proven local, locally advanced or metastatic malignancy with a solid component that is at least ≥ 10 mm in short axis for invaded adenopathies and ≥ 10 mm in long axis for all other types of lesions.
• The patient is planned for immune checkpoint inhibition treatment, either or not combined with other systemic therapies.
• COHORT 3:
• Patients who have given informed consent
• Patients at least 18 years old
• Patients planned for the surgical removal of an atherosclerotic plaque of the carotid artery, consisting of endarterectomy.
• COHORT 4:
• Patients who have given informed consent
• Patients at least 18 years old
• Patient with a biopsy-proven Hodgkin or non-Hodgkin lymphoma
• The patients are eligible for systemic treatment, radiotherapy or a combination of both.
• COHORT 5:

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Uz Brussel

Brussels, Brussels Capital, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Neoplasms; Carotid Stenosis; Hodgkin Disease; Lymphoma, Non-Hodgkin; Sarcoidosis

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hypersensitivity, Delayed; Hypersensitivity

Study Officials

• Tony Lahoutte, MD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

UZ Brussel

CONTACT

+3224776013; nucgmail@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The trial consists of 7 different patient cohorts that are each investigated using a new diagnostic imaging radiopharmaceutical

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 17, 2021
• Study Start: January 26, 2021
• Primary Completion: January 26, 2025
• Study Completion: January 26, 2025
• Last Updated: November 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)