Ex Vivo Evaluation of Experimental Radiolabeled Ligand Binding in Human Tissue Using Autohistoradiography HERO (Human Ex-vivo RadiOligand) Platform
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Ex vivo evaluation of the binding of experimental radiolabeled ligands on human tissue by autohistoradiography
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
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
- 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)
Investigators
BOURSIER Caroline
Principal Investigator
Central Hospital, Nancy, France