The Diagnostic Value of Hybrid PET/MR for Systemic Amyloidosis
1 other identifier
observational
30
1 country
1
Brief Summary
Systemic amyloidosis is a multi-system disease caused by extracellular deposition of insoluble amyloid fibrils in various tissues and organs, leading to progressive organ dysfunction. The clinical manifestations of different types of amyloidosis are complex and diverse, and the prognosis is very poor. Early detection and classification of amyloid deposition is becoming increasingly important. However, conventional imaging techniques including ultrasound and magnetic resonance are not sensitive or specific. Endocardial biopsy is the gold standard for the diagnosis of cardiac amyloidosis, but it is an invasive procedure with a clinical complication rate of 6%. Positron emission tomography (PET) provides a valuable tool for diagnosing systemic amyloidosis. Recently, amyloid PET imaging agents (11C-PIB or 18F-florbetapir) have been shown to be effective as novel positron tracers to detect potential amyloid deposition in some small sample studies. The investigators will use the most advanced imaging equipment, integrated PET/MR with amyloid PET imaging agents(11C-PIB or 18F-florbetapir) to image patients suspected or confirmed systemic amyloidosis, the aim is to explore the value of hybrid PET/MR for systemic amyloidosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 11, 2019
CompletedFirst Submitted
Initial submission to the registry
June 30, 2019
CompletedFirst Posted
Study publicly available on registry
July 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedFebruary 14, 2023
February 1, 2023
4.8 years
June 30, 2019
February 13, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Sensitivity and specificity per patient analysis
For patient without any treatment, detection and initial diagnosis, results of 11C-PiB or 18F-florbetapir PET/MR will be compared to histopathological, clinical, laboratory, radiological evidence and follow-up result.
up to 2 years
Secondary Outcomes (3)
Sensitivity and specificity per organ analysis
up to 2 years
Change after treatment
up to 2 years
Correlation with severity
up to 2 years
Study Arms (1)
11C-PIB or 18F-florbetapir PET/MR
Patients suspected of or diagnosed with systemic amyloidosis will be scanned by 11C-PIB or 18F-florbetapir PET/MR twice. One is before biopsy and treatment, and the other is after at least half a year of treatment.
Interventions
10-20 mCi 11C-PIB or 5-10 mCi 18F-florbetapir will be injected intravenously prior to imaging.
10-20 mCi 11C-PIB or 5-10 mCi 18F-florbetapir will be injected intravenously prior to imaging.
Eligibility Criteria
Central China
You may qualify if:
- Patient with Monoclonal Ganunopathy, adds one of the following criteria:
- Histologically confirmed Amyloidosis of any organ.
- Average left ventricular thickness of the echocardiogram is more than 11 mm without uncontrolled high blood pressure.
- lead ECG shows unexplained low voltage \<0.5 mV.
You may not qualify if:
- Patient can not lie flat
- NYHA Level 4 Heart Failure
- Patient is pregnant or nursing
- Patient is allergic to amyloid PET imaging agents
- Patient with acute systemic diseases and electrolyte disorders
- Patient with severe claustrophobia or unstable vital sigh
- Other serious comorbidities evaluated by primary investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China, Hubei Province
Wuhan, Hubei, 430022, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaoli Lan, MD, PhD
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Department of nuclear medicine
Study Record Dates
First Submitted
June 30, 2019
First Posted
July 5, 2019
Study Start
March 11, 2019
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
February 14, 2023
Record last verified: 2023-02