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.
Exclusion Criteria:
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
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Germans Trias i Pujol Hospital