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

NCT ID: NCT04758650

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-26
• Study Completion Date: 2025-01-26

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

68GaNOTA-Anti-MMR-VHH2

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

MMR-PET/CT

Eligibility Criteria

Inclusion Criteria

• 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.
• 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
• At time of inclusion, the patient presents with at least 1 lymphoma lesion of which the diameter should be ≥ 10 mm in short axis for invaded adenopathies and ≥ 10 mm in long axis for all other types of lesions.
• Diagnostic tissue sample is available for immunohistochemistry analysis, that was obtained < 3 months prior to patient inclusion.
• 18F-FDG-PET/CT has been performed < 3 months prior to patient inclusion
• The patients are eligible for systemic treatment, radiotherapy or a combination of both.
• COHORT 5:

• Patients who have given informed consent
• Patients at least 18 years old
• Patients with suspicion of HLH, based on either a previous bone marrow sample showing hemofagocytis or based on the presence of at least 3 risk criteria as follows :
• Fever ≥ 38,5°C
• Splenomegaly
• Bicytopenia, with at least 2 of the 3 following parameters:
• Hb < 9 g/dl and/or
• Platelets < 100 000/ml and/or
• Neutrophils < 1000/ml
• Hypertriglyceridemia (fasting > 265 mg/dl)µ
• Ferritin > 500 ng/ml
• COHORT 6:

• Patients who have given informed consent
• Patients at least 18 years old
• Patients with :

A) Endomyocardial biopsy-proven cardiac sarcoidosis (CS) or B) suspected cardiac sarcoidosis based on the 2014 Hearth Rythm Society Expert Consensus Statement on the Diagnosis and Management of Arrhytmias Associated with Cardiac Sarcoidosis. At least one of the following criteria should be met :

• Steroid +/- Immunosuppressant responsive cardiomyopathy or heart block
• Unexplained reduced left ventricular ejection fraction (LVEF) <40%
• Unexplained sustained (spontaneous or induced) ventricular tachycardia (VT)
• Mobitz type II 2nd-degree heart block or 3rd-degree heart block
• Patchy uptake on dedicated cardiac PET (in a pattern consistent with CS)
• Late Gadolinium Enhancement on Cardiovascular Magnetic Resonance (in a pattern consistent with CS)
• Positive gallium uptake (in a pattern consistent with CS)
• Histological Diagnosis from Myocardial Tissue
• Patients already included in cohort 7 with progression to cardiac sarcoidosis

*COHORT 7:

• Patients who have given informed consent
• Patients at least 18 years old
• Patients with biopsy-proven sarcoidosis

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 cannot communicate reliably with the investigator.
• 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.
• When a patient exhibits symptoms correlated with SARS-CoV-2, the patient should be tested using the standard of care testing protocol, prior to inclusion. When the test results indicate an active SARS-CoV-2-infection, the patient is excluded for this trial.

• COHORT 2

• Patients with a biopsy-proven Hodgkin or non-Hodgkin lymphoma
• Patients diagnosed with any malignancy of the head and neck. These patients can be included into Cohort I.
• COHORT 7 - Patients eligible for cohort 6

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tony Lahoutte, MD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Locations

Uz Brussel

Brussels, Brussels Capital, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

UZ Brussel

Role: CONTACT

nucgmail@uzbrussel.be

+3224776013

Facility Contacts

UZ BRUSSEL

Role: primary

nucgmail@uzbrussel.be

+3224776013

Other Identifiers

2020-002483-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

UZBRU_VHH2_2

Identifier Type: -

Identifier Source: org_study_id