Study of the Brain's Natural Cleaning System in Potential Organ Donors. (ICGBRAIN)

Study of Drainage From the Cerebral Lymphatic System to Deep Cervical Nodes by the Migration of Indocyanine Green in Recent Cadaver

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.

Study Overview

• Status: Recruiting
• Conditions: Anatomical Description
• Intervention / Treatment: Procedure: Indocynanine Green meningeal injection to understand anatomical connection from the meningeal lymphatic system to the cervical lymph nodes

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carmen Higueras, PhD; Phone Number: +34 934 65 12 00; Email: chigueras.germanstrias@gencat.cat
• Study Contact Backup: Name: Maria Del RIo, PhD; Phone Number: +34 934 65 12 00; Email: mariadelriomd@gmail.com

Study Locations

• Spain
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Recruiting
      • Germans Trias i Pujol Universitary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Potential organ donor patients, both in Brain Death and in Controlled Asystole, candidates to perform organ harvesting authorized by the Transplant and Tissue Coordination of the Universitary Germans Trias i Pujols Hospital, according to the usual channels and whose family members have previously signed the authorization of the donation and the specific informed consent of the study. Will be included in the study always after death is certified by neurological or cardiocirculatory criteria

Exclusion Criteria:

• Absence of informed consent signed by family members.
• Individuals with a history of having intracranial lymphatic drainage affected.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Interventional single arm; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
presence or absence of bilateral and symmetrical distribution of indocyanin green drainage	indocyanin green drainage pathway and distribution	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	baseline
Cervical ganglion levels to which the ICG migrates.	cervical nodes receiving the migrated ICG anatomical level location	baseline

Collaborators and Investigators

• Sponsor: Germans Trias i Pujol Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 18, 2026
• First Submitted That Met QC Criteria: June 26, 2026
• First Posted (Actual): July 2, 2026

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 26, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Alzheimer's disease; cervical lymph nodes; meningeal lymphatic system
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease
• Other Study ID Numbers: ICGBRAIN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No