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Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis (CArdiag)

Primary Purpose

Cardiac Amyloidosis, AL Amyloidosis, ATTR Amyloidosis

Status
Recruiting
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
[18F]florbetaben
Sponsored by
Life Molecular Imaging GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiac Amyloidosis focused on measuring AL Amyloidosis, ATTR Amyloidosis, Cardiac Amyloidosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males and females age ≥18 years
  • Able to understand, sign and date written informed consent
  • Written informed consent must be obtained before any assessment is performed
  • Subjects being considered for a possible diagnosis of cardiac amyloidosis by

  • 1. One of the following conditions:

    • Established systemic amyloidosis without proven cardiac involvement,
    • Known plasma cell dyscrasia (MGUS, multiple myeloma),
    • Pathological free light chain levels in urine or serum,
    • Presence of heart failure with preserved ejection fraction

  • 2. AND one of the following parameters, indicative of cardiac manifestation:

    • Mean (left ventricular (LV) wall + septum) thickness >12mm as measured by echocardiography in absence of other known cause of left ventricular hypertrophy (LVH),
    • NT-proBNP >335 ng/L
  • Planned diagnostic procedure to establish diagnosis and cardiac involvement (e.g., endomyocardial biopsy or extracardiac biopsy in conjunction with cardiac magnetic resonance imaging/echocardiography or bone scintigraphy)
  • Female subjects must be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or post-menopausal for at least 1 year (no menses for 12 months without an alternative medical cause). If they are of child-bearing potential, they must commit to use of a highly effective contraceptive measure for at least one week following the PET scan
  • Male subjects and their partners of childbearing potential must commit to the use of a highly effective method of contraception for a minimum of 90 days following the PET scan
  • Male subjects must commit to not donate sperm for a minimum of 90 days after the PET scan

Exclusion Criteria:

  • Any known allergic reactions or hypersensitivity towards any compound of the study drug
  • Severe hepatic impairment (AST/ALT >5 x ULN; bilirubin >3 x ULN)
  • Inability to lay flat for up to 60 min
  • Pregnant, lactating or breastfeeding
  • Unwilling and/or unable to cooperate with study procedures
  • Having been administered a radiopharmaceutical within 10 radioactive half-lives prior to study drug administration in this study

Sites / Locations

  • Clínica Universidad de NavarraRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with suspected cardiac amyloidosis

Arm Description

After enrolment, patients will be subjected to diagnostic procedures according to standard of care to resolve diagnostic uncertainties and to clarify possible cardiac involvement. The results of the clinical work-up will be used a standard of truth, i.e. patients with initially suspected cardiac amyloidosis that where subsequently clinically diagnosed with cardiac AL Amyloidosis, cardiac ATTR Amyloidosis, other cardiac Amyloidosis or non cardiac amyloidosis.

Outcomes

Primary Outcome Measures

Sensitivity and specificity of the visual assessment of [18F]florbetaben PET images for the diagnosis of cardiac AL amyloidosis.
The results from the visual assessment of [18F]florbetaben PET images are compared to the clinical diagnosis established through histological verification of the presence or absence of AL amyloidosis with cardiac involvement determined either through endomyocardial biopsy or through extracardiac biopsy in conjunction with typical CMR or echocardiography imaging features as the standard of truth.

Secondary Outcome Measures

Sensitivity and specificity of [18F]florbetaben PET for the diagnosis of cardiac AL amyloidosis using quantification.
The sensitivity and specificity of [18F]florbetaben PET for the diagnosis of cardiac AL amyloidosis will be determined by using quantitative image analysis.
Correlation of quantitative [18F]florbetaben PET results with left ventricular ejection fraction (LV EF) and left ventricular mass (LV mass).
Correlation of quantitative [18F]florbetaben PET results with left ventricular ejection fraction (LV EF) and left ventricular mass (LV mass).
Correlation of quantitative [18F]florbetaben PET results with AL CA stage I - IV based on FLC-diff, cTnT and NT-proBNP levels.
Correlation of quantitative [18F]florbetaben PET results with AL CA stage I - IV based on FLC-diff, cTnT and NT-proBNP levels.
Impact of PET imaging (AL-CA/non AL-CA) on diagnostic thinking and patient management will be assessed with physician's questionnaires before and after the diagnostic work-up, and after receipt of the PET results.
The impact of PET imaging (AL-CA/non AL-CA) on diagnostic thinking and patient management will be assessed with physician's questionnaires before and after the diagnostic work-up, and after receipt of the PET results.
Number of adverse events
Safety will be evaluated by collection of Adverse Events.

Full Information

First Posted
January 6, 2022
Last Updated
February 14, 2023
Sponsor
Life Molecular Imaging GmbH
Collaborators
pharmtrace klinische Entwicklung GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT05184088
Brief Title
Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis
Acronym
CArdiag
Official Title
An Open-label, Multi-center, Non-randomized Pivotal Phase 3 Study to Evaluate the Efficacy and Safety of [18F]Florbetaben Positron Emission Tomography (PET) Imaging to Diagnose Cardiac AL Amyloidosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Life Molecular Imaging GmbH
Collaborators
pharmtrace klinische Entwicklung GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an open-label, multi-center pivotal Phase 3 study to visually and quantitatively assess PET images obtained after single application of 300 MBq [18F]florbetaben and PET scanning of patients with suspected cardiac amyloidosis.
Detailed Description
This is an open-label, multi-center pivotal Phase 3 study to visually and quantitatively assess PET images obtained after single application of 300 MBq [18F]florbetaben and PET scanning of patients with suspected cardiac amyloidosis or with a putative diagnosis of cardiac amyloidosis but with remaining diagnostic uncertainty (e.g., unclear etiology or cardiac manifestation) or patients with diagnosis of amyloidosis but unclear cardiac involvement. The diagnostic efficacy of the visual and quantitative assessments of [18F]florbetaben PET images for diagnosis of cardiac AL Amyloidosis will be determined by comparison to the standard of truth (SoT) obtained through standard of care clinical diagnosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Amyloidosis, AL Amyloidosis, ATTR Amyloidosis
Keywords
AL Amyloidosis, ATTR Amyloidosis, Cardiac Amyloidosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
All eligible patients will receive a single administration of the imaging agent [18F]florbetaben at a radioactive dose of 300 MBq.
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with suspected cardiac amyloidosis
Arm Type
Experimental
Arm Description
After enrolment, patients will be subjected to diagnostic procedures according to standard of care to resolve diagnostic uncertainties and to clarify possible cardiac involvement. The results of the clinical work-up will be used a standard of truth, i.e. patients with initially suspected cardiac amyloidosis that where subsequently clinically diagnosed with cardiac AL Amyloidosis, cardiac ATTR Amyloidosis, other cardiac Amyloidosis or non cardiac amyloidosis.
Intervention Type
Drug
Intervention Name(s)
[18F]florbetaben
Other Intervention Name(s)
Neuraceq
Intervention Description
All enrolled patients will undergo [18F]florbetaben PET imaging.
Primary Outcome Measure Information:
Title
Sensitivity and specificity of the visual assessment of [18F]florbetaben PET images for the diagnosis of cardiac AL amyloidosis.
Description
The results from the visual assessment of [18F]florbetaben PET images are compared to the clinical diagnosis established through histological verification of the presence or absence of AL amyloidosis with cardiac involvement determined either through endomyocardial biopsy or through extracardiac biopsy in conjunction with typical CMR or echocardiography imaging features as the standard of truth.
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Sensitivity and specificity of [18F]florbetaben PET for the diagnosis of cardiac AL amyloidosis using quantification.
Description
The sensitivity and specificity of [18F]florbetaben PET for the diagnosis of cardiac AL amyloidosis will be determined by using quantitative image analysis.
Time Frame
Up to 12 weeks
Title
Correlation of quantitative [18F]florbetaben PET results with left ventricular ejection fraction (LV EF) and left ventricular mass (LV mass).
Description
Correlation of quantitative [18F]florbetaben PET results with left ventricular ejection fraction (LV EF) and left ventricular mass (LV mass).
Time Frame
Up to 12 weeks
Title
Correlation of quantitative [18F]florbetaben PET results with AL CA stage I - IV based on FLC-diff, cTnT and NT-proBNP levels.
Description
Correlation of quantitative [18F]florbetaben PET results with AL CA stage I - IV based on FLC-diff, cTnT and NT-proBNP levels.
Time Frame
Up to 12 weeks
Title
Impact of PET imaging (AL-CA/non AL-CA) on diagnostic thinking and patient management will be assessed with physician's questionnaires before and after the diagnostic work-up, and after receipt of the PET results.
Description
The impact of PET imaging (AL-CA/non AL-CA) on diagnostic thinking and patient management will be assessed with physician's questionnaires before and after the diagnostic work-up, and after receipt of the PET results.
Time Frame
Up to 14 weeks
Title
Number of adverse events
Description
Safety will be evaluated by collection of Adverse Events.
Time Frame
Up to 17 days after imaging visit
Other Pre-specified Outcome Measures:
Title
Sensitivity and specificity of [18F]florbetaben PET images for a differential diagnosis between AL CA, ATTR CA and non CA will be assessed.
Description
In this exploratory endpoint the sensitivity and specificity of [18F]florbetaben PET images for a differential diagnosis between AL CA, ATTR CA and non CA will be assessed.
Time Frame
Up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females age ≥18 years Able to understand, sign and date written informed consent Written informed consent must be obtained before any assessment is performed Subjects being considered for a possible diagnosis of cardiac amyloidosis by 1. One of the following conditions: Established systemic amyloidosis without proven cardiac involvement, Known plasma cell dyscrasia (MGUS, multiple myeloma), Pathological free light chain levels in urine or serum, Presence of heart failure with preserved ejection fraction 2. AND one of the following parameters, indicative of cardiac manifestation: Mean (left ventricular (LV) wall + septum) thickness >12mm as measured by echocardiography in absence of other known cause of left ventricular hypertrophy (LVH), NT-proBNP >335 ng/L Planned diagnostic procedure to establish diagnosis and cardiac involvement (e.g., endomyocardial biopsy or extracardiac biopsy in conjunction with cardiac magnetic resonance imaging/echocardiography or bone scintigraphy) Female subjects must be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or post-menopausal for at least 1 year (no menses for 12 months without an alternative medical cause). If they are of child-bearing potential, they must commit to use of a highly effective contraceptive measure for at least one week following the PET scan Male subjects and their partners of childbearing potential must commit to the use of a highly effective method of contraception for a minimum of 90 days following the PET scan Male subjects must commit to not donate sperm for a minimum of 90 days after the PET scan Exclusion Criteria: Any known allergic reactions or hypersensitivity towards any compound of the study drug Severe hepatic impairment (AST/ALT >5 x ULN; bilirubin >3 x ULN) Inability to lay flat for up to 60 min Pregnant, lactating or breastfeeding Unwilling and/or unable to cooperate with study procedures Having been administered a radiopharmaceutical within 10 radioactive half-lives prior to study drug administration in this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iris Hardewig, PhD
Phone
+49 (0)30 461 1246 03
Email
clinicaltrials@life-mi.com
First Name & Middle Initial & Last Name or Official Title & Degree
Aleksandar Jovalekic, PhD
Phone
+49 (0)30 461 1246 03
Email
clinicaltrials@life-mi.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Stephens, MD, PhD
Organizational Affiliation
Life Molecular Imaging
Official's Role
Study Director
Facility Information:
Facility Name
Clínica Universidad de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Efficacy of [18F]Florbetaben PET for Diagnosis of Cardiac AL Amyloidosis

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