Phase II study to evaluate 68GaNOTA-Anti-MMR-VHH2 , a new tracer for positron emission tomography (PET/CT) of macrophages in oncological, hematological and cardiovascular diseases.
- Conditions
- Cohort 1: pathology-proven squamous cell carcinomas of the head and neck. Cohort 2: malignancy with a solid componentCohort 3: carotid plaque, planned for (SOC) carotid endarterectomy.Cohort 4: biopsy-proven Hodgkin (HL) or non-Hodgkin lymphoma (NHL).Cohort 5: Patients suspected for hemophagocytic lymphohistiocytosis (HLH), planned for (SOC) bone marrow biopsy.Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-002483-31-BE
- Lead Sponsor
- Z Brussel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 140
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method