Indocynanine Green meningeal injection to understand anatomical connection from / Anatomical Description · Interventional Study

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

ClinicalTrials.gov · August 19, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registered interventional study that aims to visualize and describe the anatomical pathway of meningeal lymphatic drainage to cervical lymph nodes using indocyanine green fluorescence in organ donors. The registry record contains no outcome data, only the study protocol and planned measures.

What was studied

Interventional, Single Group, Open label, Other purpose. Anatomical Description; accepts healthy volunteers. Intervention: Interventional single arm. n = 10. 1 site: Spain.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

If completed and published, this anatomical study may provide evidence to support mechanistic understanding of meningeal lymphatic drainage in humans, potentially informing future therapeutic strategies for Alzheimer's disease and other neurological disorders. However, findings will be limited to the donor population and require validation in broader clinical populations.

Plain-language summary

This is a recruiting interventional study with estimated enrollment of 10 participants designed to map anatomical drainage pathways; no results are posted in this registry record.

Study design

As stated by the source record.

MethodsPrimary outcome measures: presence or absence of bilateral and symmetrical distribution of indocyanin green drainage (assessed at baseline); Assessment of the Indocyanin Grees pathways in its migration through the lymph channels to the cervical region. (assessed at baseline); Cervical ganglion levels to which the ICG migrates. (assessed at baseline)

DesignInterventional, Single Group, Open label, Other purpose

PopulationAnatomical Description; accepts healthy volunteers

Sample size10

InterventionInterventional single arm

Setting1 site: Spain

Reported figures

Quoted from the source exactly as published.

Estimated sample size10

Primary outcome measure 1Presence or absence of bilateral and symmetrical distribution of indocyanine green drainage, baseline

Primary outcome measure 2Assessment of the Indocyanine Green pathways in its migration through the lymph channels to the cervical region, baseline

Primary outcome measure 3Cervical ganglion levels to which the ICG migrates, baseline

Clinical bottom line

Caveats

This is a registry record only; no results are reported or available.
Very small sample size (10 participants) limits generalizability.
Study population restricted to organ donors, not representative of living subjects or disease populations.
Primary outcomes are descriptive anatomical measures, not clinical efficacy or disease-relevant endpoints.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Single-arm interventional study in small, non-representative population (organ donors).

Directness

moderate

Direct anatomical observation of meningeal-lymphatic drainage in humans, but in donors only.

Consistency

insufficient

Registry record reports no results; consistency cannot be assessed.

Risk of bias

insufficient

No results posted; methodological detail insufficient to assess bias risk.

Sample adequacy

limited

Estimated enrollment 10 participants; very small, descriptive study.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07682155). This is a study registration, not published results. Lead sponsor: Germans Trias i Pujol Hospital. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 10 participants (ESTIMATED). Conditions: Anatomical Description. Interventions: PROCEDURE: Indocynanine Green meningeal injection to understand anatomical connection from the meningeal lymphatic system to the cervical lymph nodes. Primary outcome measures: presence or absence of bilateral and symmetrical distribution of indocyanin green drainage , baseline; Assessment of the Indocyanin Grees pathways in its migration through the lymph channels to the cervical region. , baseline; Cervical ganglion levels to which the ICG migrates. , baseline. Brief summary: 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.

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Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT07682155Indocynanine Green meningeal injection to understand anatomical connection fromGermans Trias i Pujol HospitalAnatomical Description