Study of 68GaNOTA-Anti-MMR-VHH2 in Oncological Lesions, Cardiovascular Atherosclerosis, Syndrome With Abnormal Immune Activation and Cardiac sarcoïdosis. (MITRAS)

This is an interventional diagnostic trial for Squamous Cell Carcinoma of Head and Neck Read More

COHORT SPECIFIC INCLUSION CRITERIA:

• COHORT 1:

  • Patients who have given informed consent
  • Patients at least 18 years old
  • Patients diagnosed with biopsy-proven squamous cell carcinomas of the head and neck, independent of tumour stage.
  • In order to be eligible, a new non-surgical therapeutic approach should be considered by the treating physician(s).
  • 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 exclusion criteria apply

• COHORT 3:

  • Patients who have given informed consent
  • Patients at least 18 years old
  • Patient is 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 patient is 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 endomyocardial biopsy proven cardiac sarcoidosis or based on the presence of at least one criteria as follows : (HRS consensus recommendation (2014)
  • Corticosteroid and/or immunosuppressant-responsive cardiomyopathy or heart block
  • Unexplained reduced LVEF (<40%)
  • Unexplained sustained (spontaneous or induced) ventricular tachycardia
  • Mobitz type II second-degree block or third-degree heart block
  • Patchy uptake on dedicated cardiac FDG-PET (in a pattern consistent with CS)
  • Late Gadolinium Enhancement (LGE) on Cardiac MRI (in a pattern consistent with CS)

GENERAL EXCLUSION CRITERIA:

• 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 unlikely to cooperate with the requirements of the study.
• Patients who are unwilling and/or unable to give informed consent.
• Patients at increased risk of death from a pre-existing concurrent illness.
• 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.

COHORT SPECIFIC EXCLUSION CRITERIA

• COHORT 1

  - Patients planned for a surgical resection of the tumour.

• COHORT 2 - Patients diagnosed with squamous cell carcinomas of the head and neck. These patients can be included into Cohort I.