Efficacy of [18F]florbetaben PET for diagnosis of cardiac AL amyloidosis

Phase 1

Recruiting

• Conditions: ATTR Amyloidosis, AL Amyloidosis, Cardiac Amyloidosis; MedDRA version: 20.0Level: PTClassification code: 10007509Term: Cardiac amyloidosis Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: CTIS2022-500186-27-00
• Lead Sponsor: ife Molecular Imaging GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-28
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

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 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

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 PET radiopharmaceutical within 10 radioactive half-lives prior to study drug administration in this study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified