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

NCT07047677 | Recruiting

• 1 other identifier: 2025PI088
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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).

Conditions

Tissue Model

Outcome Measures

Primary Outcomes (1)

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

  Signal /background noise ration, in region of interest

  10 days

Secondary Outcomes (3)

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

  1 day

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

  10 days

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

  1 year

Interventions

Early assessment of tissue uptake of experimental ligands OTHER

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A maximum of 300 human tissue samples will be analyzed over a period of 5 years. This volume allows for the exploration of a variety of tissue types (tumor, inflammatory, healthy) and the testing of several types of radiolabeled molecules, while ensuring adequate reproducibility for each experimental condition. The samples will be provided by the Pathology Department of the Nancy University Hospital, in compliance with regulatory and ethical procedures. Each sample will undergo one or more ex vivo autohistoradiography analyses, without the need for any new samples.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Chru Nancy

Vandœuvre-lès-Nancy, 54511, France

RECRUITING

Central Study Contacts

Caroline BOURSIER, MD

CONTACT

(0)383154039; c.boursier@chru-nancy.fr

Véronique ROCH, MSc

CONTACT

0383154276; v.roch@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 2, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): September 1, 2030
• Last Updated: June 4, 2026

Record last verified: 2026-06

Locations

FR (1)