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 and syndrome with abnormal immune activation.

Z Brussel0 个研究点目标入组 140 人开始时间: 2020年9月28日最近更新: 2021年6月7日

试验速览

暂无简介。

•Cohort 1: Adult patients diagnosed with a squamous cell carcinoma of the head and neck (HNSCC) =10mm eligible for non-surgical therapy, independent of tumour stage.
•Cohort 2: Adult patients diagnosed with any malignancy (different from HNSCC) with a solid component =10mm, planned to receive immune checkpoint inhibition therapy.
•Cohort 3: Adult patients planned for surgical removal of an atherosclerotic plaque of the carotid artery by means of endarterectomy.
•Cohort 4: Adult patients diagnosed with Hodgkin or non-Hodgkin lymphoma 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.
•Cohort 5: Adult patients suspected for hemophagocytic lymphohisticytosis (HLH) (presence of = 3 clinical risk factors) and is planned for a standard-of-care bone marrow biopsy.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 80
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 60

•- 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 unwilling and/or unable to give informed consent
•- Patients at increased risk of death from a pre-existing concurrent illness
•- Patients with recent (< 1 week) gastrointestinal disorders (CTCAE v4.0 grade 3 or 4) with diarrhoea as major symptom (cohort 1 and 2)
•- 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.

发起方

Z Brussel