ClinicalTrials.gov record NCT07624760

Early Detection of Amyloidosis in Monoclonal Gammopathy Using Nuclear Medicine Imaging

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Early Detection of Light-Chain Amyloidosis in Monoclonal Gammopathy Using 18F-Florbetaben PET/MR: a Prospective, Single-Center, Observational Study

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age18 years old and older
SexAll
LocationSwitzerland
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This diagnostic study gives a single injection of ~300 MBq 18F‑florbetaben (Neuraceq®) and performs one whole‑body PET/MR (or PET/CT if MRI is contraindicated) to look for systemic amyloid deposits. It enrolls people with monoclonal gammopathy, including biopsy‑positive and biopsy‑negative cases, and people with biopsy‑proven AL amyloidosis. The visit is a single imaging session with monitoring during and after the scan; no follow‑up visits are planned.

What it is studying. The study tests whether 18F‑florbetaben PET/MR can detect systemic light‑chain (AL) amyloid deposits early and noninvasively across clinically and histologically defined groups. It also compares imaging findings with standard tests for organ involvement and aims to measure how much amyloid is present across early and manifest disease stages.

What the researchers hope to learn. Primary: validate 18F‑florbetaben PET for detecting systemic AL amyloidosis versus negative controls. Secondary: compare amyloid PET sensitivity with established methods (echocardiography, MRI, serological biomarkers) for early organ involvement detection. Tertiary: quantify and characterize systemic amyloid burden across early and manifest disease stages.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

The goal of this clinical trial is to evaluate whether ¹⁸F-florbetaben PET/MR can detect systemic amyloid deposits early and noninvasively in patients with monoclonal gammopathy. The main question it aims to answer is: Can ¹⁸F-florbetaben PET/MR identify systemic amyloid deposits across clinically and histologically defined patient groups? Participants will:

  • Be screened for eligibility and asked to sign an informed consent form
  • Have their vital signs measured
  • Receive a single intravenous injection of approximately 300 MBq ¹⁸F-florbetaben (Neuraceq®), followed by whole-body PET/MR imaging from skull base to below the kidneys. If MRI is contraindicated (e.g., pacemaker, severe claustrophobia), PET/CT will be performed instead. The scan takes approximately one hour, during which participants lie still in the scanner
  • Be monitored during and after the scan for any side effects or adverse events
  • Complete study participation at the end of the imaging session (single visit, no follow-up required)

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • ¹⁸F-florbetaben

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Participation in the COSMO-AL study
  • Available biopsy test result
  • Written informed consent

Exclusion criteria

  • Pregnant or lactating women

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

Aim of the Project: The overarching goal is to establish a non-invasive, sensitive method for early detection of systemic amyloid deposits, laying the foundation for earlier diagnosis and improved treatment of AL amyloidosis.

  • Primary Aim: Validate 18F-florbetaben PET for detection of systemic AL amyloidosis versus negative controls.
  • Secondary Aim: Compare the sensitivity of amyloid PET with established methods (echocardiography, MRI, serological biomarkers) for the detection of early organ involvement.
  • Tertiary Aim: Quantify and characterize systemic amyloid burden across early and manifest disease stages.

Hypotheses:

  • Amyloid PET shows pathological tracer uptake in patients with AL amyloidosis and remains unremarkable in negative controls.
  • Amyloid PET detects amyloid deposits at a stage in which conventional methods do not yet show structural or functional changes.
  • Systemic amyloid burden follows a graded pattern, with intermediate values in early disease and the highest values in manifest AL amyloidosis.

Study Design and Methods Prospective, observational cohort study at the University Hospital Zurich (USZ). 50 participants will be recruited from the established COSMO-AL cohort at the Department of Hematology, which systematically captures patients with clinically significant monoclonal gammopathy and provides standardized skin biopsy data. Participants:

  • Negative controls: monoclonal gammopathy without histologic amyloid (n = 10).
  • Early disease (study cohort): monoclonal gammopathy with local, histologically confirmed amyloid deposits (n = 20).
  • Positive controls: biopsy-confirmed systemic AL amyloidosis (n = 20). Patients with confirmed amyloid involvement will be additionally stratified by organ involvement to allow exploratory analysis of organ-specific tracer uptake.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

After giving informed consent and basic screening (vital signs), participants receive a single intravenous injection of about 300 MBq ¹⁸F‑florbetaben followed by a whole‑body PET/MR scan from the skull base to below the kidneys; the scan session takes about one hour and requires lying still. If MRI is contraindicated (for example pacemaker or severe claustrophobia), a PET/CT is performed instead. Participants are monitored during and after the scan for any side effects or adverse events. This is a single‑visit study with no scheduled follow‑up.

How the study is structured. Prospective diagnostic imaging study (observational cohort) with a non‑randomized, single‑group approach and no masking. About 50 participants will receive one intravenous dose (~300 MBq) of 18F‑florbetaben followed by a whole‑body PET/MR scan from the skull base to below the kidneys (PET/CT used if MRI is contraindicated). Participants are assigned to one of three groups (amyloid‑negative monoclonal gammopathy, biopsy‑positive monoclonal gammopathy, and biopsy‑proven systemic AL amyloidosis) for planned comparison. The procedure is a single visit lasting about an hour of scanning, with monitoring for adverse events.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in Switzerland. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on AL amyloidosis

Clinical trials69 trials listed for AL amyloidosisEvery trial the registry lists for AL amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in AL amyloidosis researchLatest monthly update: September 2026. Includes: Daratumumab alone. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
October 2026 (estimated)
Primary completion
May 2028 (estimated)
Study completion
May 2028 (estimated)
Target enrollment
50 participants (estimated)
Last updated on registry
Jun 3, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
University of Zurich

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

PET
A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
informed consent form
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
contraindicated
A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
adverse events
Any unwanted medical problem that happens during a study, whether or not it was caused by the treatment. A 'serious' adverse event is one that meets specific criteria, such as causing death, being life-threatening, requiring or prolonging hospital admission, causing significant disability, or another medically important outcome.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
biopsy
Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
echocardiography
An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
biomarkers
Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
observational cohort
A study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
cohort
A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
stratified
Randomisation done separately within subgroups, such as age bands or disease severity, so that each group contains a similar mix.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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