MRI-visible Enlarged Perivascular Spaces and the Alteration of Lymphatic Drainage System in CAA

NCT04604587 | Unknown Phase 3

• 1 other identifier: 201912003MINC
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

In this three-year proposal, we will explore the MRI-visible EPVS in CAA and investigate its pathophysiology using animal models. Our specific aims include: (1) Establish the relationship of MRI-visible enlarged perivascular space and CAA, (2) Determine whether vascular amyloid clearance in CAA is associated with lymphatic drainage system, (3) Establish longitudinal data for MRI-visible enlarged perivascular space and cerebral amyloid angiopathy progression.

Conditions

Cerebral Amyloid Angiopathy; Intracerebral Hemorrhage

Keywords

Cerebral Amyloid Angiopathy; Intracerebral Hemorrhage; Magnetic resonance imaging; Position emitting topography

Outcome Measures

Primary Outcomes (1)

• PET imaging

  PET data will reconstruct with ordered set expectation maximization, corrected for attenuation, and each frame will be evaluated to verify adequate count statistics and absence of head motion.

  in 3 days

Study Arms (1)

amyloid PET、T807 PET

EXPERIMENTAL

PET/CT

Drug: 1. amyloid PET；2. T807 PET

Interventions

1. amyloid PET；2. T807 PET DRUG

1. Dynamic PET acquisition for 70 minutes will be acquired after injection of 10±5 mCi 11C-PiB 2. Dynamic PET imaging 3D acquisition will be acquired 80 minutes after injection of 10 mCi 18F-T807

amyloid PET、T807 PET

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age：above 20 years old.
• Evidence of intraparenchymal hemorrhage on CT or MRI.
• Patient agrees to participate in the study and receive neurophsychological examinations, genetic and biochemical markers test, MRI and PET imaging.

You may not qualify if:

• patients with potential causes of hemorrhage including trauma, structural lesion, brain tumor, or coagulopathy due to systemic disease or medication.
• Patients could not receive the PET and MRI studies, including but not limited to poor cooperative agitation impeding adequate study, allergy to contrast medium, hemodynamic instability, implantation of cardiac pacemaker, past history of receiving aneurysm clipping, panic mood to MRI study, impaired kidney function.
• Patients with pregnancy or recently having a plan for pregnancy.
• Patients with breast feeding or recently having a plan for breast feeding.
• Patients with history of allergy to 11C-PiB and 18F-T807, or severe allergy history.
• Patient or family who does not agree to participate in the study.
• patient with high risk by doctor evaluate.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan Univeristy Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Cerebral Amyloid Angiopathy; Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Cerebral Arterial Diseases; Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Amyloidosis; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 27, 2020
• Study Start: October 8, 2020
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: October 27, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)