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Study of 68GaNOTA-Anti-MMR-VHH2 in Oncological Lesions, Cardiovascular Atherosclerosis, Syndrome With Abnormal Immune Activation and sarcoïdosis | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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

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,Syndrome With Abnormal Immune Activation and sarcoïdosis

NCT04758650•Universitair Ziekenhuis Brussel

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•COHORT 1:
•\- Patients who have given informed consent
•\- Patients at least 18 years old
•\- Patients with : A) biopsy-proven solid malignancy located in the head and neck, independent of tumour stage or pathological subtype, or B) suspected malignancy in the head and neck, planned for biopsy
•* 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.
•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.
+42 more criteria

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.
+4 more criteria

Locations (1)

Uz Brussel

Brussels, Brussels Capital, Belgium

Key Dates

Start Date

January 26, 2021

Primary Completion Date

January 26, 2025

Completion Date

January 26, 2025

Last Updated

November 18, 2023

Enrollment

140

ESTIMATED participants

Conditions

Solid Malignancy Located in the Head and NeckCancerCarotid StenosisAtherosclerosis of ArteryHodgkin Lymphoma, AdultNon Hodgkin LymphomaHLHCardiac SarcoidosisSarcoidosis

Interventions

68GaNOTA-Anti-MMR-VHH2

DRUG

Contacts

UZ Brussel

CONTACT

+3224776013 nucgmail@uzbrussel.be

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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