Study of 68GaNOTA-Anti-MMR-VHH2 in Oncological Lesions and Cardiovascular Atherosclerosis and Syndrome With Abnormal Immune Activation.

  • STATUS
    Recruiting
  • End date
    Jan 26, 2025
  • participants needed
    140
  • sponsor
    Universitair Ziekenhuis Brussel
Updated on 18 December 2021
atherosclerosis
lymphoma
bone marrow procedure
18f-fdg
primary cancer
recurrent disease
pet/ct scan
endarterectomy
mannose
pet-ct scan

Summary

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 and patients with cardiovascular atherosclerosis and syndrome with abnormal immune activation.

Details
Condition Squamous Cell Carcinoma of Head and Neck, Cancer, Carotid Stenosis, Atherosclerosis of Artery, Hodgkin Lymphoma, Adult, Non Hodgkin Lymphoma, HLH
Treatment 68GaNOTA-Anti-MMR-VHH2
Clinical Study IdentifierNCT04758650
SponsorUniversitair Ziekenhuis Brussel
Last Modified on18 December 2021

Eligibility

Yes No Not Sure

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
F-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
Patient who are planned to undergo bone marrow biopsy with suspected HLH by presence of ≥ 3 clinical risk factors
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

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
Patients with recent (< 1 week) gastrointestinal disorders (CTCAE v5.0 grade 3 or 4) with diarrhoea as major symptom
COHORT 2
Patients with recent (< 1 week) gastrointestinal disorders (CTCAE v5.0 grade 3 or 4) with diarrhoea as major symptom
Patients diagnosed with squamous cell carcinomas of the head and neck. These patients can be included into Cohort I
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