RECRUITING

Molecular Imaging of Primary Amyloid Cardiomyopathy

Conditions

Amyloidosis, Primary Cardiomyopathy amyloidosis F-18 florbetapir Positron emission tomography cardiac magnetic resonance imaging

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Cardiac amyloidosis is a major cause of early treatment-related death and poor overall survival in individuals with systemic light chain amyloidosis. This project will develop a novel approach to visualize cardiac amyloid deposits using advanced imaging methods. The long-term goal of this work is to identify the mechanisms of cardiac dysfunction, in order to guide the development of novel life-saving treatments.

Official Title

Molecular Imaging of Primary Amyloid Cardiomyopathy

Quick Facts

Study Start:2016-04-01

Study Completion:2025-01-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02641145

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age \> 18 years * Diagnosis of light chain amyloidosis by standard criteria (immunofixation of serum and urine, IgG free light chain (FLC) assay, a biopsy of fat pad/ bone marrow, or organ biopsy, followed by typing of the light chain using immunohistochemistry or immunogold assay with confirmation by Mass spectroscopy as needed) * For subjects traveling from out of town referred for systemic AL therapy based on clinical evaluation and laboratory testing, but, pending biopsy results, study enrollment and procedures may begin before official confirmation of biopsy results. If biopsy is negative for AL amyloidosis, subject will be considered a screen failure. There will be no more than 10 subjects who fall under this screen failure for the duration of the study. * Subjects with localized amyloid deposition and non-systemic AL disease will be eligible for enrollment in group D. * Willing and able to provide consent * Additional inclusion criteria for the Remission AL-CMP: Hematological response defined as complete hematological remission or very good partial response-differential free light chain (dFLC)\<40 mg/dL for \> 1 year prior to enrollment * Additional inclusion criteria for the Active AL-CMP - exercise: Ability to perform supine bicycle exercise. Enrollment to this arm will stop after 36 subjects complete baseline and 6 months studies. * Additional inclusion criteria for the Active AL Pre-CMP - Normal left ventricular wall thickness (≤ 12 mm) and normal LVEF (≥55%) on echocardiography within 3 months or increased wall thickness with normal cardiac biomarker levels: not meeting above definition. * Additional inclusion criteria for Control Multiple Myeloma subjects: diagnosis of multiple myeloma without concomitant amyloidosis by standard criteria * Additional inclusion criteria for Control Heart Failure subjects: diagnosis of heart failure without amyloidosis by standard criteria * Additional inclusion criteria for the active AL-CMP: Abnormal TnT 5th generation levels (\>9 ng/L: Female, \>14 ng/L: Male) or abnormal age appropriate N terminal pro-brain natriuretic peptide, NT-proBNP (abnormal values: \<50 years: \>450 pg/ml; 50-75 years:\>900 pg/ml; \>75 years: \>1800 pg/ml)	* Hemodynamic instability * Decompensated heart failure (unable to lie flat for 1 hour) * Concomitant non-ischemic non-amyloid heart disease (valvular heart disease or dilated cardiomyopathy) * Known obstructive epicardial coronary artery disease with stenosis \> 50% in any single territory * Severe claustrophobia despite use of sedatives * Presence of MRI contraindications such as metallic implants (pacemaker or ICD) at the time of study enrollment except for Control Heart Failure subjects. Control HF subjects with no devices, or, with strictly MR compatible devices will be eligible to undergo MRI. * Significant renal dysfunction with estimated glomerular filtration rate \< 30 ml/min/m2 within 14 days of each cardiac MRI study. Subjects who develop renal dysfunction over the course of the study, meeting criteria listed above, will be excluded from the cardiac MRI scan except for control HF subjects. These subjects with eGFR \< 30 ml/min/1.73 m2 will undergo MRI without gadolinium contrast. * Subjects on dialysis will be excluded * Pregnant state. For women in child bearing age, a urine pregnancy test will be performed prior to the PET and the cardiac MRI studies * Documented allergy to F-18 florbetapir, C-11 acetate or gadolinium. * Additional exclusion criteria for the active AL-CMP subjects: Subjects unable to return to BWH for 6 and 12 month clinical evaluation * Additional exclusion criteria for active AL-CMP-exercise subjects: Inability to exercise or return to BWH for C-11 acetate PET/CT at baseline and 6 month clinical evaluations. * Additional exclusion criteria for active AL Pre-CMP- Inability to return to BWH 12 month clinical evaluation.

Inclusion Criteria

Exclusion Criteria

* Age \> 18 years
* Diagnosis of light chain amyloidosis by standard criteria (immunofixation of serum and urine, IgG free light chain (FLC) assay, a biopsy of fat pad/ bone marrow, or organ biopsy, followed by typing of the light chain using immunohistochemistry or immunogold assay with confirmation by Mass spectroscopy as needed)
* For subjects traveling from out of town referred for systemic AL therapy based on clinical evaluation and laboratory testing, but, pending biopsy results, study enrollment and procedures may begin before official confirmation of biopsy results. If biopsy is negative for AL amyloidosis, subject will be considered a screen failure. There will be no more than 10 subjects who fall under this screen failure for the duration of the study.
* Subjects with localized amyloid deposition and non-systemic AL disease will be eligible for enrollment in group D.
* Willing and able to provide consent
* Additional inclusion criteria for the Remission AL-CMP: Hematological response defined as complete hematological remission or very good partial response-differential free light chain (dFLC)\<40 mg/dL for \> 1 year prior to enrollment
* Additional inclusion criteria for the Active AL-CMP - exercise: Ability to perform supine bicycle exercise. Enrollment to this arm will stop after 36 subjects complete baseline and 6 months studies.
* Additional inclusion criteria for the Active AL Pre-CMP - Normal left ventricular wall thickness (≤ 12 mm) and normal LVEF (≥55%) on echocardiography within 3 months or increased wall thickness with normal cardiac biomarker levels: not meeting above definition.
* Additional inclusion criteria for Control Multiple Myeloma subjects: diagnosis of multiple myeloma without concomitant amyloidosis by standard criteria
* Additional inclusion criteria for Control Heart Failure subjects: diagnosis of heart failure without amyloidosis by standard criteria
* Additional inclusion criteria for the active AL-CMP: Abnormal TnT 5th generation levels (\>9 ng/L: Female, \>14 ng/L: Male) or abnormal age appropriate N terminal pro-brain natriuretic peptide, NT-proBNP (abnormal values: \<50 years: \>450 pg/ml; 50-75 years:\>900 pg/ml; \>75 years: \>1800 pg/ml)

* Hemodynamic instability
* Decompensated heart failure (unable to lie flat for 1 hour)
* Concomitant non-ischemic non-amyloid heart disease (valvular heart disease or dilated cardiomyopathy)
* Known obstructive epicardial coronary artery disease with stenosis \> 50% in any single territory
* Severe claustrophobia despite use of sedatives
* Presence of MRI contraindications such as metallic implants (pacemaker or ICD) at the time of study enrollment except for Control Heart Failure subjects. Control HF subjects with no devices, or, with strictly MR compatible devices will be eligible to undergo MRI.
* Significant renal dysfunction with estimated glomerular filtration rate \< 30 ml/min/m2 within 14 days of each cardiac MRI study. Subjects who develop renal dysfunction over the course of the study, meeting criteria listed above, will be excluded from the cardiac MRI scan except for control HF subjects. These subjects with eGFR \< 30 ml/min/1.73 m2 will undergo MRI without gadolinium contrast.
* Subjects on dialysis will be excluded
* Pregnant state. For women in child bearing age, a urine pregnancy test will be performed prior to the PET and the cardiac MRI studies
* Documented allergy to F-18 florbetapir, C-11 acetate or gadolinium.
* Additional exclusion criteria for the active AL-CMP subjects: Subjects unable to return to BWH for 6 and 12 month clinical evaluation
* Additional exclusion criteria for active AL-CMP-exercise subjects: Inability to exercise or return to BWH for C-11 acetate PET/CT at baseline and 6 month clinical evaluations.
* Additional exclusion criteria for active AL Pre-CMP- Inability to return to BWH 12 month clinical evaluation.

Contacts and Locations

Study Contact

Sharmila Dorbala, MD, MPH

CONTACT

617-732-6290

sdorbala@partners.org

Principal Investigator

Sharmila Dorbala, MD

PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital (AHA and NIH Studies)

Rodney Falk, MD

PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital (NIH Study)

Ronglih Liao, PhD

PRINCIPAL_INVESTIGATOR

Stanford School of Medicine (AHA Study)

Study Locations (Sites)

Brigham and Womens' Hospital

Boston, Massachusetts, 02421

United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

Sharmila Dorbala, MD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital (AHA and NIH Studies)
Rodney Falk, MD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital (NIH Study)
Ronglih Liao, PhD, PRINCIPAL_INVESTIGATOR, Stanford School of Medicine (AHA Study)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-04-01

Study Completion Date2025-01-08

Study Record Updates

Study Start Date2016-04-01

Study Completion Date2025-01-08

Terms related to this study

Keywords Provided by Researchers

amyloidosis
F-18 florbetapir
Positron emission tomography
cardiac magnetic resonance imaging

Additional Relevant MeSH Terms

Amyloidosis, Primary
Cardiomyopathy