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NCT06957821 · ClinicalTrials.gov registry record · Early Phase 1
Study to Image Inflammatory Activity of a Fluorescence Imaging Agent in Excised Human Artery Plaques
A Early Phase 1 study, sponsored by Massachusetts General Hospital.
- Not yet
- Registry status
- Early Phase 1
- Development phase
- 25
- Enrollment target
NCT06957821: Clinical Trial Early Phase 1 study, sponsored by Massachusetts General Hospital.
NCT06957821 is a Early Phase 1 study that has not yet begun recruiting, run by Massachusetts General Hospital. The registered enrollment target is 25 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06957821, a Early Phase 1 study, has not yet begun recruiting, sponsored by Massachusetts General Hospital.
- NOT YET RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 25 participants
- Enrollment target
Study Summary
Active inflammation plays a key role in causing Coronary Artery Disease (CAD) and Peripheral Arterial Disease (PAD). Since inflammation is so important in how these diseases start, are diagnosed, and treated, being able to see it clearly in each patient could lead to more personalized and effective care - and may help prevent heart attacks. Right now, there's no imaging technology available to clearly see inflammation inside the coronary arteries. The investigators hope to learn how an imaging drug; called LUMISIGHT (Pegulicianine) can help detect inflammation in blood vessels compared with saline. If the investigators find out that LUMISIGHT is active in humans, the investigators might be able to use it for detecting plaque risk in the future.
Primary Outcome
Mean difference in plaque for fluorescence ratio to show that fluorescence in the Lumisight cohort is 2 fold greater than that of the control
Interventions
- OTHER Placebo
- DRUG Pegulicianine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2026-06 |
| Est. Completion | 2029-12 |
| Phase | Early Phase 1 |
What is known before NCT06957821 opens enrollment
NCT06957821 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT06957821 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06957821 about?
NCT06957821 is a clinical study titled "Study to Image Inflammatory Activity of a Fluorescence Imaging Agent in Excised Human Artery Plaques". Active inflammation plays a key role in causing Coronary Artery Disease (CAD) and Peripheral Arterial Disease (PAD). Since inflammation is so important in how these diseases start, are diagnosed, and treated, being able to see it clearly in each patient could lead to more personalized and effective ...
What is the current status of trial NCT06957821?
This trial is currently not yet recruiting. It is a Early Phase 1 study. The enrollment target is 25 participants. The study started on 2026-06. Estimated completion is 2029-12.
What interventions are being tested in trial NCT06957821?
The interventions under investigation include: Placebo (OTHER), Pegulicianine (DRUG).
Who is sponsoring clinical trial NCT06957821?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06957821's enrollment target sits among peer trials
25 1000th of 2000 higher than 964 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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