NCT07560306 [64Cu]FBP8 Thrombosis Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07560306 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 22 July 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07560306 is a hot trial to watch
Thrombosis is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07560306 is notable because it evaluates [64Cu]FBP8 in a Phase 3 design sponsored by The Brigham & Women's Hospital, Inc.. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07560306 |
| Official title | [64Cu]FBP8 PET for Early Detection of Intracardiac Thrombus in Amyloid Cardiomyopathy |
| Phase / status | Phase 3 / Recruiting |
| Intervention | [64Cu]FBP8 |
| Sponsor | The Brigham & Women's Hospital, Inc. |
| Geography | United States |
| Enrollment | [object Object] |
| Primary endpoint | Intracardiac Thrombus |
| Endpoint time frame | 1 day |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
The primary goal of this pilot study is to determine whether [64Cu]FBP8, a novel fibrin-binding positron emission tomography (PET) probe, can identify intracardiac thrombi when paired with simultaneous hybrid cardiac PET/MRI in twenty (20) individuals with transthyretin or light chain cardiac amyloidosis and atrial fibrillation (AF) or atrial flutter (AF). The primary hypothesis of this study is that [64Cu]FBP8 PET/MRI can identify intracardiac thrombi in >90% of subjects with confirmed intracardiac thrombi based on transesophageal echocardiogram (TEE). In secondary analyses, the investigators will seek to determine associations between intracardiac thrombi and left atrial function and left ventricular amyloid burden.
Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment of [object Object] participants across United States shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.
- Intracardiac Thrombus (1 day) — Presence or absence of intracardiac thrombus based on \[64Cu\]FBP8 PET/MR imaging, as determined by standardized uptake values (SUV), and transesophageal echocardiogram
Readout outlook and evidence gap
The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
Build a living trial monitor: connect to PatSnap MCP Servers and track recruitment, endpoint revisions, projected readouts and new result records without manually reconciling separate databases.
Asset and sponsor context
Drug & Asset MCP profile: [64Cu]FBP8 is indexed as Peptide Conjugate Radionuclide, Diagnostic radiopharmaceuticals, with target fibrin, mechanism fibrin modulators, and global highest development status Phase 3.
Company & Deal Intelligence MCP profile: The Brigham & Women's Hospital, Inc. did not return an exact normalized organization match in this snapshot. The organization workflow adds identity, location, portfolio and partnering context where available.
The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.
White space around this program
- Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
- Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
- Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
- Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
- Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.
What to monitor next
Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.
Bottom line
NCT07560306 provides a focused lens on Thrombosis development. Its value will be determined by whether [64Cu]FBP8 can convert the current Phase 3 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
Ready to reproduce this analysis? Explore PatSnap MCP Servers and combine Clinical Trials, Drug & Asset, and Company & Deal Intelligence as reusable building blocks for trial monitoring and SEO-ready clinical reports.
