An interventional study of Indocynanine Green meningeal injection to understand anatomical connection from the meningeal lymphatic system to the cervical lymph nodes in Anatomical Description, sponsored by Germans Trias i Pujol Hospital. Recruiting at 1 site in Spain. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Germans Trias i Pujol Hospital · Not applicable, Interventional, and Other
Alzheimer's disease is a condition that affects the brain and is associated with the build-up of waste substances that can damage brain cells. Scientists have recently discovered a natural drainage and cleaning system around the brain, called the meningeal lymphatic system, which may help remove these waste products.
Researchers believe that this brain drainage system is connected to lymph nodes located in the neck. However, this connection has not yet been clearly demonstrated in humans because it is difficult to study.
The purpose of this study is to investigate how fluid drains from the brain to the lymph nodes in the neck. To do this, researchers will use a fluorescent dye called indocyanine green, which can be seen with a special camera. The study will be carried out in potential organ donors who have been authorized for organ donation.
The researchers will record images and videos to observe how the dye moves, how long it takes to reach the lymph nodes, whether the drainage is similar on both sides of the body, and which lymph nodes are involved.
A better understanding of these drainage pathways may help researchers develop and improve future treatments for Alzheimer's disease and other neurological disorders.
Design Prospective interventionist study: in which the flow of lymph fluid from the intracranial region to the deep cervical ganglia will be studied in the potential organ donor (PDO).
Study population Potential organ donor patients (PDO), both donors in Brain Death and Donors in Controlled Asystole, candidates to perform extraction thereof and authorized by the Transplant Coordination of the University Germans Trias i Pujol Hospital.
total number of subjects There will be 20 flow measurements, so if it is bilateral, there would be 10 potential donors.
Variables Images and videos will be obtained using the fluorescence camera. To be evaluated: time, direction, ganglion levels, symmetry. Data source Memory storage of the PDE (Hamamatsu, Photonics) fluorescence device. They will be collected in a database.
Medical history of the donor. Medicinal product or medical device under evaluation (where applicable) Not applicable Data analysis The images and videos collected will be evaluated, analyzing the variables in the different corpses.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 10 is below the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Germans Trias i Pujol Hospital is the lead sponsor of 89 studies on the registry; 12 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
During the donor's usual organ removal, a bicoronal incision and craniectomy will be performed to inject a small amount of indocyanin green into the meningeal space and evaluate migration with a fluorescence chamber. A small cervical lateral incision is added for flow monitoring and ends with the aesthetic closure of this. It will be completed with the aesthetic closure of the incisions, which can also be easily hidden.
Procedure: Indocynanine Green meningeal injection to understand anatomical connection from the meningeal lymphatic system to the cervical lymph nodes
Bicoronal incision and craniectomy will be performed to inject a small amount of indocyanin green into the meningeal space and evaluate migration with a fluorescence chamber. A small cervical lateral incision is added for flow monitoring and ends with the aesthetic closure of this. It will be completed with the aesthetic closure of the incisions, which can also be easily hidden.
presence or absence of bilateral and symmetrical distribution of indocyanin green drainage
indocyanin green drainage pathway and distribution
Time frame: baseline
Assessment of the Indocyanin Grees pathways in its migration through the lymph channels to the cervical region.
The fluorescence camera will be used to take images and videos to assess whether flow drainage is present or absent
Time frame: baseline
Cervical ganglion levels to which the ICG migrates.
cervical nodes receiving the migrated ICG anatomical level location
Time frame: baseline
Plan to share: No — The porpouse of this clinical study is to know the existence of a migration flow from the meningeal lymphatic system and cervical lymph nodes. It doesn't describe the population or subjects
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Nov 2026, 9 months after the start.
Of 882 non-industry interventional studies with no phase under Alzheimer Disease, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 51. This study's planned 9 months is below that.
Counting every sponsor, half of 959 studies reached it within 29 months; a quarter within 15 and three quarters within 51.
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Germans Trias i Pujol Hospital