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

Who is this study for? Patients with Cardiac Amyloidosis
What treatments are being studied? [18F]florbetaben
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Males and females age ≥18 years

• Able to understand, sign and date written informed consent

• Written informed consent must be obtained before any study procedures are 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 or CMR in absence of other known cause of left ventricular hypertrophy (LVH),

⁃ NT-proBNP \>335 ng/L (in case a value for NT-proBNP is not available, BNP \> 81ng/L may be used instead)

• 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 (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, bilaterial tubal occlusion, vasectomised parner or secual 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 the PET scan (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, bilaterial 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

Locations
United States
Kansas
St Luke's Hospital
RECRUITING
Kansas City
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
University of Pittsburgh
RECRUITING
Pittsburgh
Other Locations
Germany
University of Augsburg
RECRUITING
Augsburg
Charite Berlin
RECRUITING
Berlin
University of Essen
RECRUITING
Essen
HOPA Hamburg
RECRUITING
Hamburg
University of Heidelberg
RECRUITING
Heidelberg
University of Würzburg
RECRUITING
Würzburg
Spain
Hospital University Bellvitge
RECRUITING
Barcelona
Hospital University Puerta de Hierro
RECRUITING
Madrid
Clínica Universidad de Navarra
RECRUITING
Pamplona
University of Salamanca
RECRUITING
Salamanca
United Kingdom
Royal Free Hospital
RECRUITING
London
Contact Information
Primary
Iris Hardewig, PhD
clinicaltrials@life-mi.com
+49 (0)30 461 1246 03
Backup
Aleksandar Jovalekic, PhD
clinicaltrials@life-mi.com
+49 (0)30 461 1246 03
Time Frame
Start Date: 2023-01-13
Estimated Completion Date: 2026-03
Participants
Target number of participants: 200
Treatments
Experimental: Patients with suspected cardiac amyloidosis
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.
Sponsors
Leads: Life Molecular Imaging GmbH
Collaborators: pharmtrace klinische Entwicklung GmbH

This content was sourced from clinicaltrials.gov