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

NCT ID: NCT07047677

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2030-09-01

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).

Conditions

Tissue Model

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Interventions

Early assessment of tissue uptake of experimental ligands

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

BOURSIER Caroline

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Caroline BOURSIER, MD

Role: CONTACT

c.boursier@chru-nancy.fr

(0)383154039 ext. +33

Véronique ROCH, MSc

Role: CONTACT

v.roch@chru-nancy.fr

0383154276 ext. +33

Other Identifiers

2025PI088

Identifier Type: -

Identifier Source: org_study_id