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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07047677
Acronym
HERO
Enrollment
300
Registered
2025-07-02
Start date
2025-11-01
Completion date
2030-09-01
Last updated
2026-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tissue Model

Brief summary

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

OTHEREarly assessment of tissue uptake of experimental ligands

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

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Ex vivo evaluation of the binding of experimental radiolabeled ligands on human tissue by autohistoradiography10 daysSignal /background noise ration, in region of interest

Secondary

MeasureTime frameDescription
Identify specific tissue fixation profiles according to the nature of the molecules (Antibodies, peptides, nanobodies, etc.).1 daySignal/background noise ratio (calculated between the target area and a healthy area on the same slice).
Compare the biodistribution of the molecule of interest between different types of tissues (tumor, inflammatory, healthy, etc.).10 daysAnalysis of biodistribution across the entire section (depending on the nature of the tissue).
Identify ligands exhibiting specific and relevant tissue binding, warranting further in vivo evaluation.1 yearInter-tissue differences (tumor, inflammatory, healthy tissue, etc.) for the same molecule.

Countries

France

Contacts

CONTACTCaroline BOURSIER, MD
c.boursier@chru-nancy.fr(0)383154039
CONTACTVéronique ROCH, MSc
v.roch@chru-nancy.fr0383154276

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 5, 2026