# Clinical translation of targeted intracoronary imaging for inflammatory activity

> **NIH NIH R01** · MASSACHUSETTS GENERAL HOSPITAL · 2024 · $712,744

## Abstract

Inflammatory activity plays a major role in the development and progression of coronary artery disease (CAD),
the major cause of mortality in the US and around the world. Until now, there has been no way to visualize and
quantify coronary inflammation with the precision required to impact patient management. There is an
opportunity for this capability gap to change, as a new clinical near-infrared fluorescence (NIRF) imaging agent
called LUM015 has recently been introduced for cancer applications. LUM015 fluoresces following active
cathepsin cleavage and thus appears promising as a highly specific targeted agent for inflammatory activity in
atherosclerosis, as cathepsins are key mediators of plaque progression and coronary thrombosis risk.
In this grant, we propose to investigate a first-in-human use of LUM015 NIRF for intracoronary CAD assessment.
We will accomplish this objective by developing and clinically validating a multimodality imaging system and
catheter that simultaneously obtains co-localized, intracoronary optical coherence tomography (OCT) images of
lesional microanatomy and LUM015 NIRF to evaluate cathepsin-mediated plaque inflammatory activity. This
technology will be clinically translated by investigating the targeting profile and dosing parameters for LUM015
in animal models of atherosclerosis and in humans undergoing carotid endarterectomy (Aim 1). Technology will
be developed to spectrally unmix LUM015 NIRF from NIR autofluorescence (NIRAF) that is prevalent in
advanced CAD (Aim 2.1). We also will advance NIRF-OCT technology by creating an innovative two-fiber
catheter/rotary junction that removes fiber autofluorescence background. The resultant increase in LUM015
NIRF sensitivity will allow the time between injection and imaging to be minimized, which is important to capture
many patients undergoing cardiac catheterization (Aim 2.2). The new catheter will also improve OCT image
quality, which is inferior in current multimodality systems. After completion of Aims 1 and 2, the intravascular
LUM015 NIRF-OCT technology will be tested in patients undergoing cardiac catheterization to show that NIRF-
OCT can predict CAD severity (Aim 3). By establishing a new clinical imaging methodology for evaluating
coronary microstructure and inflammatory activity in vivo, this work will have a major impact on CAD research,
drug development, and personalized CAD management aimed at improving clinical outcomes.

## Key facts

- **NIH application ID:** 10877138
- **Project number:** 5R01HL165453-03
- **Recipient organization:** MASSACHUSETTS GENERAL HOSPITAL
- **Principal Investigator:** Farouc Amin Jaffer
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $712,744
- **Award type:** 5
- **Project period:** 2022-07-22 → 2027-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10877138

## Citation

> US National Institutes of Health, RePORTER application 10877138, Clinical translation of targeted intracoronary imaging for inflammatory activity (5R01HL165453-03). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10877138. Licensed CC0.

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