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Recruiting NCT07047677

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

Observational Tissue Model

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Early assessment of tissue uptake of experimental ligands.
Who it may be relevant to
Registry conditions: Tissue Model. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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).

Detailed description

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).

Interventions

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

Primary outcome measures

  • Ex vivo evaluation of the binding of experimental radiolabeled ligands on human tissue by autohistoradiography [Time frame: 10 days]
Secondary outcome measures (3)
  • Identify specific tissue fixation profiles according to the nature of the molecules (Antibodies, peptides, nanobodies, etc.). [Time frame: 1 day]
  • Compare the biodistribution of the molecule of interest between different types of tissues (tumor, inflammatory, healthy, etc.). [Time frame: 10 days]
  • Identify ligands exhibiting specific and relevant tissue binding, warranting further in vivo evaluation. [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

France · 1 center
  • Chru Nancy — Vandœuvre-lès-Nancy

Identifiers

NCT: NCT07047677 · 2025PI088

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗