Ex Vivo Evaluation on Human Tissue of the Binding of Experimental Radiolabeled Ligands

Официальное название

Ex Vivo Evaluation of Experimental Radiolabeled Ligand Binding in Human Tissue Using Autohistoradiography HERO (Human Ex-vivo RadiOligand) Platform

Обзор

The HERO project aims to structure an ex vivo screening platform, based on anonymized human tissues, to early assess the tissue fixation of experimental ligands in an ethical, translational approach that complies with the principles of the 3Rs (Replacement, Reduction, Refinement).

Подробное описание

The development of radioligands targeting structures of diagnostic or therapeutic interest is a central challenge in nuclear medicine. However, their selection still relies primarily on animal models, which are poorly representative of human tissue, limiting clinical transposability and delaying innovation, in contradiction with the ethical principles of animal experimentation.

Recent work has highlighted the value of ex vivo approaches on human tissue to better anticipate the specificity of radioligand binding, while reducing the need for animal models. Autohistoradiography, in particular, allows precise visualization of the tissue distribution of radiolabeled molecules, without systemic interference.

The HERO project aims to structure an ex vivo screening platform, based on anonymized human tissues, to early assess the tissue fixation of experimental ligands in an ethical, translational approach that complies with the principles of the 3Rs (Replacement, Reduction, Refinement).

Вмешательства

• Другое Early assessment of tissue uptake of experimental ligands
  Ex vivo evaluation of the binding of experimental radiolabeled ligands on human tissue using autohistoradiography

Первичные конечные точки

• Ex vivo evaluation of the binding of experimental radiolabeled ligands on human tissue by autohistoradiography [Срок оценки: 10 days]

Вторичные конечные точки (3)

• Identify specific tissue fixation profiles according to the nature of the molecules (Antibodies, peptides, nanobodies, etc.). [Срок оценки: 1 day]
• Compare the biodistribution of the molecule of interest between different types of tissues (tumor, inflammatory, healthy, etc.). [Срок оценки: 10 days]
• Identify ligands exhibiting specific and relevant tissue binding, warranting further in vivo evaluation. [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Patients who underwent surgical resection at the Nancy University Hospital after 2019 (Information provided in the welcome booklet or on posters displayed in waiting rooms, mentioning the possible use of data or resection specimens, unless otherwise stated).
• No documented objection, in accordance with the MR004 methodology.
• Frozen human tissues (slides, blocks, or sections) from surgical resection or biopsy, transmitted by the CRB or the biopathology department.
• Samples are fully anonymized before being made available for analysis.

Критерии исключения

• • Unusable tissue (degraded, insufficient, contaminated, poorly preserved).

• Lack of traceability of the material.
• Explicit opposition from the patient to the use of their tissue for research.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Франция · 1 центр

• Chru Nancy — Vandœuvre-lès-Nancy

Идентификаторы

NCT: NCT07047677 · 2025PI088

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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