ClinicalTrials.gov record NCT06921408
Retrospective Identification of Scintigraphic Cardiac Amyloidosis (RISCA)
Retrospective Identification of Scintigraphic Cardiac Amyloidosis Using Deep Learning-based Model
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 retrospective observational study examines past bone scintigraphy scans taken for reasons other than suspected amyloidosis. People whose scans show incidental cardiac uptake will be recalled for a one-day diagnostic reassessment. The study aims to find how often incidental uptake indicates transthyretin cardiac amyloidosis.
What it is studying. Whether incidental cardiac uptake seen on routine bone scintigraphy predicts a diagnosis of transthyretin cardiac amyloidosis (measuring the positive predictive value of that finding).
What the researchers hope to learn. To determine the positive predictive value of incidental cardiac uptake on bone scintigraphy for diagnosing transthyretin cardiac amyloidosis and to describe diagnostic outcomes after reassessment.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
This study aims to determine the positive predictive value of incidental cardiac uptake on bone scintigraphy for diagnosing transthyretin cardiac amyloidosis, in patients who underwent scintigraphy for reasons other than suspected amyloidosis. The study is an observational, descriptive, multicenter, national study using retrospective data from routine care. Patients with incidental cardiac uptake will be recalled for further diagnostic assessment.
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Adults (≥ 18 years)
- Patients who underwent bone scintigraphy with 99mTc-HMDP/DPD/PYP for any indication
- Incidental cardiac uptake (Perugini grade ≥2) confirmed by a nuclear medicine specialist
Exclusion criteria
- Patients under legal protection
- Patients refusing the reuse of their data after individual information
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
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.
The study uses existing clinical scans and records from routine care. If your prior scan meets the study criterion, the team may contact you and invite you for a one-day reassessment evaluation for further diagnostic assessment. If you refuse reuse of your data after receiving individual information, you will not be included.
How the study is structured. A retrospective, multicenter observational cohort study using existing routine-care bone scintigraphy images. Patients with incidental cardiac uptake on those past scans will be identified and invited back for a one-day diagnostic reassessment.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry lists this study under Cardiac Amyloidosis; Transthyretin Amyloidosis. Does it apply to my diagnosis?
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- No sites are listed on the registry yet. Where will the study take place?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on ATTRv amyloidosis
This trial is also listed on this site under wild-type ATTR amyloidosis.
Important dates
- Study start
- Sep 1, 2026 (estimated)
- Primary completion
- Jul 1, 2027 (estimated)
- Study completion
- Dec 1, 2027 (estimated)
- Target enrollment
- 57 participants (estimated)
- Last updated on registry
- May 15, 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 Hospital, Lille
- Collaborators
- Pfizer
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.
- Marc-Antoine DELBARRE 📞 +33 3 20 44 59 69 ✉ marcantoine.delbarre@gmail.com
Participating sites
Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.
Terms used on this page · explanations by MedicalUpdates.ai
- 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.
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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