RECRUITING

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

Conditions

Cardiac Amyloidosis AL Amyloidosis ATTR Amyloidosis

Quick Navigation

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

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.

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

Quick Facts

Study Start:2023-01-13

Study Completion:2025-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05184088

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

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Iris Hardewig, PhD

CONTACT

+49 (0)30 461 1246 03

clinicaltrials@life-mi.com

Aleksandar Jovalekic, PhD

CONTACT

+49 (0)30 461 1246 03

clinicaltrials@life-mi.com

Principal Investigator

Andrew Stephens, MD, PhD

STUDY_DIRECTOR

Life Molecular Imaging

Study Locations (Sites)

St Luke's Hospital

Kansas City, Kansas, 64111

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213

United States

Collaborators and Investigators

Sponsor: Life Molecular Imaging GmbH

Andrew Stephens, MD, PhD, STUDY_DIRECTOR, Life Molecular Imaging

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 Date2023-01-13

Study Completion Date2025-06

Study Record Updates

Study Start Date2023-01-13

Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

AL Amyloidosis
ATTR Amyloidosis
Cardiac Amyloidosis

Additional Relevant MeSH Terms

Cardiac Amyloidosis
AL Amyloidosis
ATTR Amyloidosis