Study to Image Inflammatory Activity of a Fluorescence Imaging Agent in Excised Human Artery Plaques

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06957821
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Carotid Artery Diseases
  • Peripheral Arterial Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pegulicianine — DRUG
    Pegulicianine (LUMISIGHT) Inflammatory activity
  • Placebo — OTHER
    Control group for the study

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Jul 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
25 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: PEGULICIANINE (LUMISIGHT)
    Twenty (20) participants will receive 1.0 mg/kg of LUMISIGHT
  • Placebo Comparator: Normal Saline
    Five(5) participants will receive saline injections and be considered controls

Primary Outcome Measure

Demonstrate lumisight fluorescence activity in lumisight cohort vs controls [ Time Frame: 2-6 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Anita Chung
6177244515

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