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Clinical Trials List

Protocol Number201912003MINC

NCT Number(ClinicalTrials.gov Identfier)NCT04604587

2020-08-01 - 2025-07-31

Others

Recruiting2

ICD-10E85.0

Non-neuropathic heredofamilial amyloidosis

ICD-10E85.1

Neuropathic heredofamilial amyloidosis

ICD-10E85.2

Heredofamilial amyloidosis, unspecified

ICD-10E85.3

Secondary systemic amyloidosis

ICD-10E85.4

Organ-limited amyloidosis

ICD-10E85.8

Other amyloidosis

ICD-10E85.9

Amyloidosis, unspecified

ICD-9277.3

Amyloidosis

MRI-visible Enlarged Perivascular Spaces and the Alteration of Lymphatic Drainage System in Cerebral Amyloid Angiopathy

Trial Applicant
Sponsor

National Taiwan University Hospital
Trial scale

Taiwan Single Center
Update

2025/08/20

Investigators and Locations

Principal Investigator

National Taiwan University Hospital Bei-Hu Branch

Co-Principal Investigator

蔡欣熹 Division of Neurology

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator CHIA-JU LIU Division of Nuclear Medicine

National Taiwan University Hospital

Co-Principal Investigator

Jiann-Shing Jeng Division of Neurology
RUOH-FANG YEN Division of Nuclear Medicine
YA-FANG CHEN Division of Radiology
LI-KAI TSAI Division of Neurology

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Cerebral Amyloid Angiopathy(CAA)

Objectives

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.

Test Drug

(1)11C-PiB (2)18F-T807

Active Ingredient

(1)N-methyl-[11C]2-(4-methylaminophenyl)-6-hydroxyenzothiazole
(2)7-(6- [18F]fluoropyridin-3-yl)-5H-pyrido[4,3-b]indole

Dosage Form

IVT
IVT

Dosage

10±5
10

Endpoints

Primary Outcome Measures :

PET imaging [ Time Frame: in 3 days ]
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.

Inclution Criteria

Inclusion Criteria:

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.

Exclusion Criteria

Exclusion Criteria:

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.

The Estimated Number of Participants

Taiwan

120 participants
Global

0 participants