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NCT Number: NCT07047677

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

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).

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Key information

Conditions

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chru Nancy

Vandœuvre-lès-Nancy, 54511, France

Location status: Recruiting

Location contact

Veronique Roch, MSc

CONTACT

[email protected]

0383154276

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Early assessment of tissue uptake of experimental ligands

Other

Ex vivo evaluation of the binding of experimental radiolabeled ligands on human tissue using autohistoradiography

Primary outcomes

  1. Ex vivo evaluation of the binding of experimental radiolabeled ligands on human tissue by autohistoradiography

    Time frame: 10 days

    Signal /background noise ration, in region of interest

Secondary outcomes

  1. Identify specific tissue fixation profiles according to the nature of the molecules (Antibodies, peptides, nanobodies, etc.).

    Time frame: 1 day

    Signal/background noise ratio (calculated between the target area and a healthy area on the same slice).

  2. Compare the biodistribution of the molecule of interest between different types of tissues (tumor, inflammatory, healthy, etc.).

    Time frame: 10 days

    Analysis of biodistribution across the entire section (depending on the nature of the tissue).

  3. Identify ligands exhibiting specific and relevant tissue binding, warranting further in vivo evaluation.

    Time frame: 1 year

    Inter-tissue differences (tumor, inflammatory, healthy tissue, etc.) for the same molecule.

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline BOURSIER, MD

CONTACT

[email protected]

(0)383154039 ext. +33

Véronique ROCH, MSc

CONTACT

[email protected]

0383154276 ext. +33

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: HERO

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
Jul 2, 2025
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.