Study of 68GaNOTA-Anti-MMR-VHH2 in Oncological Lesions and Cardiovascular Atherosclerosis.

• Status: Recruiting
• Trial end date: 2025-01-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitair Ziekenhuis Brussel

Criteria

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.

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.

• 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.