Ex Vivo Evaluation on Human Tissue of the Binding of Experimental Radiolabeled Ligands
ConditionTissue Model
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorCentral Hospital, Nancy, France
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
• 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.
Trial 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.
Trial design
Design model
Other
Time perspective
Retrospective
Treatments tested in this trial
Early assessment of tissue uptake of experimental ligands
Other interventionEx vivo evaluation of the binding of experimental radiolabeled ligands on human tissue using autohistoradiography
Treatment groups
No treatment groups listed
Trial outcomes
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
Time frame
10 daysSecondary outcomes
1
Identify specific tissue fixation profiles according to the nature of the molecules (Antibodies, peptides, nanobodies, etc.).
Signal/background noise ratio (calculated between the target area and a healthy area on the same slice).
Time frame
1 day2
Compare the biodistribution of the molecule of interest between different types of tissues (tumor, inflammatory, healthy, etc.).
Analysis of biodistribution across the entire section (depending on the nature of the tissue).
Time frame
10 days3
Identify ligands exhibiting specific and relevant tissue binding, warranting further in vivo evaluation.
Inter-tissue differences (tumor, inflammatory, healthy tissue, etc.) for the same molecule.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov