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Looking for participantsPhase1

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

Sponsor: Lantheus Germany GmbH

NCT ID: NCT06790394

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Florbetaben F18 (drug)
How long the study runs
Study runs about 11 months (dates as stated)
About the drug or intervention
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.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
40 Years and over
Who
All
Number of participants
15
Started
2025-10-21
Last checked
2026-07

Plain English Summary

What is this study?

  • • Testing a new treatment for cardiac amyloidosis
  • • Phase1 - 15 participants
  • • 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

Who can take part?

  • • Ages 40 Years and over
  • • Diagnosed with cardiac amyloidosis

Where?

  • • London - Royal Free Hospital
  • • London - King's College London

This is a simplified summary. Always discuss with your doctor before making any decisions.

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.

Cardiac Amyloidosis

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 40 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Inclusion criteria (for all subjects):
  • ✓Males and females aged ≥40 years
  • ✓Able to understand, sign, and date written agreement to take part
  • ✓Written agreement to take part must be obtained before any assessment is performed
  • ✓Male subjects must commit to not donate sperm for a minimum of 90 days after the PET scan

Who cannot take part

  • ✗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 the study treatment
  • ✗red blood cell level value \< 10 g/dL
  • ✗Severe liver impairment (liver enzymes or liver enzymes \>5 x ULN; liver blood test \>3 x ULN)
  • ✗Subject receives hemodialysis or peritoneal dialysis
See the full criteria
Inclusion Criteria: * Inclusion criteria (for all subjects): * 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) * 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 * Medications taken for treatment of multiple myeloma or chronic diseases of the heart or tafamides treatment are maintained on a stable dosage regimen. * Patients on stable coagulation, if arterial blood sampling isperformed. * Inclusion criteria for AL-CA and ATTR-CA patients: • Patients with a clinical diagnosis of cardiac AL amyloidosis or cardiac ATTR diagnosis according to diagnostic criteria * Inclusion criteria for control patients: The control subjects must meet one of the following criteria: * Patients without heart failure and no suspicion of cardiac amyloidosis OR * Patients with impaired heart function but cardiac amyloidosis ruled out by echocardiography, CMR or cardiac biopsy OR * Patients with known plasma cell dyscrasia (MGUS, multiple myeloma) but no clinical signs of cardiac amyloidosis detected by echocardiography or CMR Exclusion Criteria: * 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) * Subject receives hemodialysis or peritoneal dialysis * Inability to lay flat for up to 60 min * Pregnant, lactating or breastfeeding * Unwilling and/or unable to cooperate with study procedures * Having received a PET scan within one week before the 18F\]florbetaben PET scan * For patients were arterial sampling isperformed: Subject has a contraindication to arterial cannulation, including but not limited to allergy to local anesthetics, peripheral vascular disease, Raynaud's phenomenon as determined by abnormal Allen's test or abnormal coagulation profile at screening.

Where Is This Study? (2 UK sites)

Royal Free Hospital

London NW3 2QG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Natasha Ajraam

rf-tr.randd@nhs.net020 375 82150

King's College London

London SE1 7EH, United Kingdom

COMPLETED
Hospital R&D contact (matched)

Jasmine Palmer

kch-tr.research@nhs.net0203 299 1980

How to Get in Touch

Sónia Alves

Sponsor contact

CONTACT

004930461124660 lifemi-cati@lantheus.onmicrosoft.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-07