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 sites140 target enrollmentSeptember 28, 2020

Overview

No summary available.

Registry

who.int

Start Date

September 28, 2020

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Z Brussel

•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

•\- 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.