Atherosclerosis of Artery, Cancer, Cardiac Sarcoidosis, Carotid Stenosis, HLH, Hodgkin Lymphoma, Adult, Non Hodgkin Lymphoma, Sarcoidosis, Solid Malignancy Located in the Head and Neck
Conditions
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.
Interventions
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.
Sponsors
Universitair Ziekenhuis Brussel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
The trial consists of 7 different patient cohorts that are each investigated using a new diagnostic imaging radiopharmaceutical
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
COHORT SPECIFIC 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. * Patients who already participated in the trial and who are diagnosed with progressive or recurrent disease can be re-included if all inclusion criteria and none of the
Exclusion criteria
apply. * 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. * Patients who already participated in the trial and who are diagnosed with progressive or recurrent disease can be re-included if all inclusion criteria and none of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 |
| 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 |
| 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 |
| 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 |
Countries
Belgium
Contacts
PRINCIPAL_INVESTIGATORTony Lahoutte, MD
Universitair Ziekenhuis Brussel
Outcome results
None listed