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 |
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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 |
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 |
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 |
Group/Cohort | Intervention/treatment |
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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.
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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.
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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 |
Inclusion Criteria:
Patient with Monoclonal Ganunopathy, adds one of the following criteria:
Exclusion Criteria:
Contact: Xiaoli Lan, MD, PhD | +86-13886193262 | lxl730724@hotmail.com |
China, Hubei | |
China, Hubei Province | Recruiting |
Wuhan, Hubei, China, 430022 | |
Contact: Xiaoli Lan +86-13886193262 lxl730724@hotmail.com |
Principal Investigator: | Xiaoli Lan, MD, PhD | Wuhan Union Hospital, China |
Tracking Information | |||||
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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 |
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.
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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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. |
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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. |
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Central China | ||||
Condition |
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Intervention |
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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:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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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 |
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IPD Sharing Statement |
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Responsible Party | Xiaoli Lan, Wuhan Union Hospital, China | ||||
Study Sponsor | Wuhan Union Hospital, China | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Wuhan Union Hospital, China | ||||
Verification Date | September 2020 |