Carotid Artery DiseasesEarly Phase 1NCT06957821
Study to Image Inflammatory Activity of a Fluorescence Imaging Agent in Excised Human Artery Plaques
A Early Phase 1 study testing Pegulicianine in people with Carotid Artery Diseases and Peripheral Arterial Disease, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carotid Artery Diseases, Peripheral Arterial Disease
- What is being tested?
- Pegulicianine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to Dec 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have an established diagnosis of severe carotid or peripheral arterial disease (ischemic or aneurysmal) requiring surgery and be sufficiently healthy to undergo surgery
- Must be age of 18 years or older
- Must be able to give informed consent
- Women with childbearing potential must have a negative pregnancy test
- Estimated glomerular filtration rate ≥ 60 mL/min/1.73 m2 (mild renal impairment
Who cannot join
- History of allergic reaction to oral or intravenous contrast agents
- History of allergic reaction to polyethylene glycol (PEG)
- History of allergic or anaphylactic reactions
- Participants who have taken an investigational drug within 14 days of enrollment.
- Participants with hemodynamic instability
- Any history of renal failure (estimated Glomerular Filtration Rate (eGFR) <60ml/min/1.73 m2)
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- Pregnant or lactating females
- Participants with uncontrolled hypertension defined as persistent systolic blood pressure > 180 mm Hg, or diastolic blood pressure > 110 mm Hg; those subjects with known HTN should be under these values while under pharmaceutical therapy
- Severe concurrent illnesses including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, COPD or asthma requiring hospitalization within the past 12 months, or psychiatric illness/social situations that would limit compliance with study requirements
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
Anita Chung, 6177244515, achung7@mgh.harvard.edu
About this study
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.
Read the detailed description
Objective of this research is to find out if a new imaging drug called LUMISIGHT can show inflammation inside blood vessels for participants with severe coronary and peripheral arterial disease. This will allow us to obtain information about diseases that cause inflammation in the heart and blood vessels.
On the day of the procedure, at least 2 hours before the surgery, consented study participants will be injected with either the LUMISIGHT or saline. Following the injection, study participants will be monitored and observed for 30 minutes for any allergic reactions. Study participants will then undergo the standard of care surgery for their clinical care. During the procedure, surgeon will take out blocked pieces of subjects' blood vessel for clinical care. The investigators will get these discarded pieces and image it with a special imaging system developed by the Tearney Lab. This system uses a thin tube with a light-based camera (called Optical Coherence Tomography-Near Infra Red Fluorescence or OCT-NIRF) to capture detailed images.
- Being tested
- Pegulicianine, Placebo
- Medical subject headings
- Carotid Artery Diseases, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PegulicianineDrug
Also called LUMISIGHT
Pegulicianine (LUMISIGHT) Inflammatory activity
PlaceboOther
Control group for the study
| Study group | Role | What they receive |
|---|---|---|
| PEGULICIANINE (LUMISIGHT) | Experimental | Twenty (20) participants will receive 1.0 mg/kg of LUMISIGHT Receives: Drug: Pegulicianine |
| Normal Saline | Placebo comparator | Five(5) participants will receive saline injections and be considered controls Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate lumisight fluorescence activity in lumisight cohort vs controls
Mean difference in plaque for fluorescence ratio to show that fluorescence in the Lumisight cohort is 2 fold greater than that of the control
Measured: 2-6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2025
- Study startJun 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery DiseasesStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Guillermo Tearney, Massachusetts General Hospital
- Investigators
- Guillermo Tearney, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957821
- Sponsor's protocol ID
- 2024P002945
- Other IDs
- 5R01HL165453-03
- Status last verified
- Apr 2026
- First submitted
- 2 May 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Image Inflammatory Activity of a Fluorescence Imaging Agent in Excised Human Artery Plaques
- ClinicalTrials.gov ID
- NCT06957821
- Acronym / sponsor ID
- 2024P002945
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 5 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objective of this research is to find out if a new imaging drug called LUMISIGHT can show inflammation inside blood vessels for participants with severe coronary and peripheral arterial disease. This will allow us to obtain information about diseases that cause inflammation in the heart and blood vessels.
On the day of the procedure, at least 2 hours before the surgery, consented study participants will be injected with either the LUMISIGHT or saline. Following the injection, study participants will be monitored and observed for 30 minutes for any allergic reactions. Study participants will then undergo the standard of care surgery for their clinical care. During the procedure, surgeon will take out blocked pieces of subjects' blood vessel for clinical care. The investigators will get these discarded pieces and image it with a special imaging system developed by the Tearney Lab. This system uses a thin tube with a light-based camera (called Optical Coherence Tomography-Near Infra Red Fluorescence or OCT-NIRF) to capture detailed images.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEGULICIANINE (LUMISIGHT) | Experimental | Drug: PegulicianineTwenty (20) participants will receive 1.0 mg/kg of LUMISIGHT |
| Normal Saline | Placebo comparator | Other: PlaceboFive(5) participants will receive saline injections and be considered controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must have an established diagnosis of severe carotid or peripheral arterial disease (ischemic or aneurysmal) requiring surgery and be sufficiently healthy to undergo surgery
- Must be age of 18 years or older
- Must be able to give informed consent
- Women with childbearing potential must have a negative pregnancy test
- Estimated glomerular filtration rate ≥ 60 mL/min/1.73 m2 (mild renal impairment
Key exclusion criteria (9 listed)
- History of allergic reaction to oral or intravenous contrast agents
- History of allergic reaction to polyethylene glycol (PEG)
- History of allergic or anaphylactic reactions
- Participants who have taken an investigational drug within 14 days of enrollment.
- Participants with hemodynamic instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PegulicianineAlso: LUMISIGHTPegulicianine (LUMISIGHT) Inflammatory activity | Drug | PEGULICIANINE (LUMISIGHT) |
| PlaceboControl group for the study | Other | Normal Saline |
Primary outcome
Demonstrate lumisight fluorescence activity in lumisight cohort vs controls
Time frame: 2-6 hours
Mean difference in plaque for fluorescence ratio to show that fluorescence in the Lumisight cohort is 2 fold greater than that of the control
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillermo Tearney, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Pegulicianine in people with Carotid Artery Diseases and Peripheral Arterial Disease, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anita Chung (6177244515, achung7@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate lumisight fluorescence activity in lumisight cohort vs controls (time frame: 2-6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.