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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 exclusion criteria apply
- •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
- •GENERAL EXCLUSION CRITERIA:
- •Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher.
- 另有 13 项未显示
研究组 & 干预措施
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
干预措施: 68GaNOTA-Anti-MMR-VHH2 (Drug)
结局指标
主要结局
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
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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).
时间窗: 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).
时间窗: 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)
时间窗: up to 5 years
Uptake in lesions involved with sarcoidosis on MMR-PET/CT
次要结局
未报告次要终点