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出境医 / 临床实验 / The Diagnostic Value of Hybrid PET/MR for Systemic Amyloidosis

The Diagnostic Value of Hybrid PET/MR for Systemic Amyloidosis

Study Description
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.


Condition or disease Intervention/treatment
Systemic Amyloidosis PET/MR Diagnostic Test: 11C-PIB or 18F-florbetapir PET/MR before biopsy and treatment Diagnostic Test: 11C-PIB or 18F-florbetapir PET/MR after treatment

Detailed Description:

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 multiple organs 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.

For patients suspected of or diagnosed with systemic amyloidosis, the investigators aim to evaluate the roles of hybrid PET/MR in differential diagnosis, detecting the deposition of amyloid in various tissues and organs of the body, guiding biopsy, and determining treatment plan prior to treatment; for the patients with a history of systemic amyloidosis, the aim is to evaluate the value of hybrid PET/MR for treatment response assessment.

Study Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Diagnostic Value of Hybrid PET/MR for Systemic Amyloidosis
Actual Study Start Date : March 11, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Group/Cohort Intervention/treatment
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.
Diagnostic Test: 11C-PIB or 18F-florbetapir PET/MR before biopsy and treatment
10-20 mCi 11C-PIB or 5-10 mCi 18F-florbetapir will be injected intravenously prior to imaging.

Diagnostic Test: 11C-PIB or 18F-florbetapir PET/MR after treatment
10-20 mCi 11C-PIB or 5-10 mCi 18F-florbetapir will be injected intravenously prior to imaging.

Outcome Measures
Primary Outcome Measures :
  1. Sensitivity and specificity per patient analysis [ Time Frame: up to 2 years ]
    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.


Secondary Outcome Measures :
  1. Sensitivity and specificity per organ analysis [ Time Frame: up to 2 years ]
    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.

  2. Change after treatment [ Time Frame: up to 2 years ]
    For patient after treatment, change of PET/MR scan and clinical/radiological/histopathological indices.

  3. Correlation with severity [ Time Frame: up to 2 years ]
    Correlation of 11C-PiB or 18F-florbetapir uptake with clinical/radiological/histopathological indices of amyloidosis severity.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Central China
Criteria

Inclusion Criteria:

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.
  • 12-lead ECG shows unexplained low voltage <0.5 mV.

Exclusion Criteria:

  • 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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Xiaoli Lan, MD, PhD +86-13886193262 lxl730724@hotmail.com

Locations
Layout table for location information
China, Hubei
China, Hubei Province Recruiting
Wuhan, Hubei, China, 430022
Contact: Xiaoli Lan    +86-13886193262    lxl730724@hotmail.com   
Sponsors and Collaborators
Wuhan Union Hospital, China
Investigators
Layout table for investigator information
Principal Investigator: Xiaoli Lan, MD, PhD Wuhan Union Hospital, China
Tracking Information
First Submitted Date June 30, 2019
First Posted Date July 5, 2019
Last Update Posted Date February 9, 2021
Actual Study Start Date March 11, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 30, 2019)
Sensitivity and specificity per patient analysis [ Time Frame: up to 2 years ]
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 30, 2019)
  • Sensitivity and specificity per organ analysis [ Time Frame: up to 2 years ]
    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.
  • Change after treatment [ Time Frame: up to 2 years ]
    For patient after treatment, change of PET/MR scan and clinical/radiological/histopathological indices.
  • Correlation with severity [ Time Frame: up to 2 years ]
    Correlation of 11C-PiB or 18F-florbetapir uptake with clinical/radiological/histopathological indices of amyloidosis severity.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Diagnostic Value of Hybrid PET/MR for Systemic Amyloidosis
Official Title The Diagnostic Value of Hybrid PET/MR for Systemic Amyloidosis
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.

Detailed Description

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 multiple organs 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.

For patients suspected of or diagnosed with systemic amyloidosis, the investigators aim to evaluate the roles of hybrid PET/MR in differential diagnosis, detecting the deposition of amyloid in various tissues and organs of the body, guiding biopsy, and determining treatment plan prior to treatment; for the patients with a history of systemic amyloidosis, the aim is to evaluate the value of hybrid PET/MR for treatment response assessment.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Central China
Condition
  • Systemic Amyloidosis
  • PET/MR
Intervention
  • Diagnostic Test: 11C-PIB or 18F-florbetapir PET/MR before biopsy and treatment
    10-20 mCi 11C-PIB or 5-10 mCi 18F-florbetapir will be injected intravenously prior to imaging.
  • Diagnostic Test: 11C-PIB or 18F-florbetapir PET/MR after treatment
    10-20 mCi 11C-PIB or 5-10 mCi 18F-florbetapir will be injected intravenously prior to imaging.
Study Groups/Cohorts 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:
  • Diagnostic Test: 11C-PIB or 18F-florbetapir PET/MR before biopsy and treatment
  • Diagnostic Test: 11C-PIB or 18F-florbetapir PET/MR after treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 30, 2019)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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.
  • 12-lead ECG shows unexplained low voltage <0.5 mV.

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Xiaoli Lan, MD, PhD +86-13886193262 lxl730724@hotmail.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04006223
Other Study ID Numbers XLan-S895
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Xiaoli Lan, Wuhan Union Hospital, China
Study Sponsor Wuhan Union Hospital, China
Collaborators Not Provided
Investigators
Principal Investigator: Xiaoli Lan, MD, PhD Wuhan Union Hospital, China
PRS Account Wuhan Union Hospital, China
Verification Date September 2020