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

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Updated on 18 December 2021

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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 Identifier	NCT04758650
Sponsor	Universitair Ziekenhuis Brussel
Last Modified on	18 December 2021

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