Test-retest Study With [18F]FBB in Cardiac Amyloidosis

ConditionCardiac Amyloidosis

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age40+

SponsorLantheus Germany GmbH

About this trial

This study is an open-label study to evaluate and characterize test-retest reliability of \[18F\]florbetaben PET in subjects with AL-CA and ATTR-CA compared to non-CA subjects. Quantification of the \[18F\]florbetaben parameters related to the deposition of amyloid in the heart (such as Myocardial Tracer Retention (MTR) or Retention Index (RI)), and the variability in these parameters after repeated imaging will be evaluated. Measurement of blood metabolites and comparison of invasive with non-invasive quantification of \[18F\]florbetaben uptake in the heart will be performed.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Males and females aged ≥40 years

Able to understand, sign, and date written informed consent

Written informed consent must be obtained before any assessment is performed

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)

Disqualifiers

Subject has received, in the last 3 months, or currently receives amyloid targeting monoclonal antibody therapy.

Any known allergic reactions or hypersensitivity towards any compound of the study drug

Hemoglobin value < 10 g/dL

Severe hepatic impairment (AST or ALT >5 x ULN; bilirubin >3 x ULN)

Trial design

Design model

Single group

Treatments tested in this trial

Florbetaben F18
Drug
Florbetaben F18 is a radioactive diagnostic agent being developed for the indication of PET imaging of the heart to detect amyloid pathology. All patients will receive two administrations of Florbetaben F18 at a radioactive dose of 300 megabecquerel (MBq).

Treatment groups

15 Participants

are divided into 1 treatment group

Group A: Patients with cardiac diseaseExperimental treatment 1 intervention

Trial outcomes