NCT06790394 Test-retest Study With [18F]FBB in Cardiac Amyloidosis
| NCT ID | NCT06790394 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Lantheus Germany GmbH |
| Condition | Cardiac Amyloidosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-10-21 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 15 participants in total. It began in 2025-10-21 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06790394 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Cardiac Amyloidosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06790394 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06790394 currently recruiting?
Yes, NCT06790394 is actively recruiting participants. Contact the research team at CATI@life-mi.com for enrollment information.
Where is the NCT06790394 trial being conducted?
This trial is being conducted at London, United Kingdom, London, United Kingdom.
Who is sponsoring the NCT06790394 clinical trial?
NCT06790394 is sponsored by Lantheus Germany GmbH. The trial plans to enroll 15 participants.