Tissue ModelHERONCT07047677
Ex Vivo Evaluation on Human Tissue of the Binding of Experimental Radiolabeled Ligands
An observational study of Tissue Model, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Tissue Model
- What is being tested?
- Early assessment of tissue uptake of experimental ligands
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2025to 1 Sep 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- • 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chru Nancy
Vandœuvre-lès-Nancy, 54511
Veronique Roch, MSc, 0383154276, v.roch@chru-nancy.fr
About this study
Official title: Ex Vivo Evaluation of Experimental Radiolabeled Ligand Binding in Human Tissue Using Autohistoradiography HERO (Human Ex-vivo RadiOligand) Platform
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).
Read the 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
- Being tested
- Early assessment of tissue uptake of experimental ligands
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early assessment of tissue uptake of experimental ligandsOther
Ex vivo evaluation of the binding of experimental radiolabeled ligands on human tissue using autohistoradiography
What is being measured
The primary outcome is the main question the study is designed to answer.
Ex vivo evaluation of the binding of experimental radiolabeled ligands on human tissue by autohistoradiography
Signal /background noise ration, in region of interest
Measured: 10 days
Secondary outcomes (3)
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).
Measured: 1 day
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).
Measured: 10 days
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start1 Nov 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tissue ModelStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BOURSIER Caroline, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047677
- Sponsor's protocol ID
- 2025PI088
- Acronym
- HERO
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2025
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ex Vivo Evaluation of Experimental Radiolabeled Ligand Binding in Human Tissue Using Autohistoradiography HERO (Human Ex-vivo RadiOligand) Platform
- ClinicalTrials.gov ID
- NCT07047677
- Acronym / sponsor ID
- HERO / 2025PI088
- Conditions
- Tissue Model
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Sep 2030 (estimated)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- • Unusable tissue (degraded, insufficient, contaminated, poorly preserved).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early assessment of tissue uptake of experimental ligandsEx vivo evaluation of the binding of experimental radiolabeled ligands on human tissue using autohistoradiography | Other | – |
Primary outcome
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
3 secondary outcomes
Identify specific tissue fixation profiles according to the nature of the molecules (Antibodies, peptides, nanobodies, etc.).
Time frame: 1 day
Compare the biodistribution of the molecule of interest between different types of tissues (tumor, inflammatory, healthy, etc.).
Time frame: 10 days
Identify ligands exhibiting specific and relevant tissue binding, warranting further in vivo evaluation.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tissue Model, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline BOURSIER, MD ((0)383154039 ext. +33, c.boursier@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ex vivo evaluation of the binding of experimental radiolabeled ligands on human tissue by autohistoradiography (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.