The Diagnostic Value of Hybrid PET/MR for Systemic Amyloidosis

NCT ID: NCT04006223

Last Updated: 2023-02-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-11
• Study Completion Date: 2023-12-31

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.

Conditions

Systemic Amyloidosis; PET/MR

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

11C-PIB or 18F-florbetapir PET/MR before biopsy and treatment

Intervention Type: DIAGNOSTIC_TEST

10-20 mCi 11C-PIB or 5-10 mCi 18F-florbetapir will be injected intravenously prior to imaging.

11C-PIB or 18F-florbetapir PET/MR after treatment

Intervention Type: DIAGNOSTIC_TEST

10-20 mCi 11C-PIB or 5-10 mCi 18F-florbetapir will be injected intravenously prior to imaging.

Interventions

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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Xiaoli Lan

Director of the Department of nuclear medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaoli Lan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Locations

China, Hubei Province

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaoli Lan, MD, PhD

Role: CONTACT

lxl730724@hotmail.com

+86-13886193262

Facility Contacts

Xiaoli Lan

Role: primary

lxl730724@hotmail.com

+86-13886193262

Other Identifiers

XLan-S895

Identifier Type: -

Identifier Source: org_study_id