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Efficacy of [18F]florbetaben PET for diagnosis of cardiac AL amyloidosis
EU CTIS ID: 2022-500186-27-00
What this study is testing
To determine the sensitivity and specificity of the visual assessment of [18F]florbetaben PET images for the diagnosis of cardiac AL amyloidosis compared to the standard of care clinical diagnosis
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 procedures 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 one week after the PET scan (including combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner or sexual abstinence).
You likely can't join if
- 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 PET radiopharmaceutical within 10 radioactive half-lives prior to study drug administration in this study
See the full eligibility criteria
Who can join
- 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 procedures 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 one week after the PET scan (including combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner or sexual abstinence).
- 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 each PET scan (including, for female partners of childbearing potential, combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, male subjects with vasectomy or sexual abstinence).
- Male subjects must commit to not donate sperm for a minimum of 90 days after the PET scan
What rules you out
- 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 PET radiopharmaceutical within 10 radioactive half-lives prior to study drug administration in this study
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.