# Molecular Imaging Agent to Detect Thrombus

> **NIH NIH R44** · COLLAGEN MEDICAL, LLC · 2021 · $496,849

## Abstract

Project Summary
Thrombus as a clinical entity is responsible for the largest number of deaths and greatest morbidity compared to
any other pathology. Most major cardiovascular diseases, including myocardial infarction, atrial fibrillation, acute
coronary syndrome, stroke, pulmonary embolism, and deep vein thrombosis, are either a result of thrombosis or
can cause thrombosis. Recently, the pandemic COVID-19 has been found to be associated with increased
coagulopathy, which likely contributes to the development of acute respiratory distress and even multi-organ
failure in these patients. Detection of thromboemboli and their source thrombus are vital to proper patient
management across all of these diseases. Currently thrombi are detected by different anatomical imaging
methods depending on the vascular territory, but all techniques have limitations (e.g. require sedation, require
nephrotoxic contrast, cannot be used in certain patients). No existing method can be used to assess different
vascular territories for thrombus in a single multistation exam, while this would be extremely valuable in
thromboembolic diseases like deep vein thrombosis (DVT) / pulmonary embolism (PE) or stroke where it is
important to not only detect the embolus but the embolic source as well. Current methods do not inform on
composition of the thrombus and the fibrin content, although therapeutic strategies (e.g., thrombolysis for a fibrin
rich clot identified by positron emission tomography (PET) vs. mechanical thrombectomy for an organized, fibrin-
poor, chronic thrombus) would benefit from such information.
Collagen Medical is developing a fibrin-specific molecular PET probe, 68Ga-CM500 that can identify thrombus
anywhere in the body following a single intravenous injection followed by PET imaging. Ultimately, we are
seeking regulatory approval for the indication “68Ga-CM500 detects thrombus” which require demonstration of
efficacy for thrombus detection in different vascular territories, such as the deep veins, pulmonary arteries, and
cardiac chambers. Using a closely related probe, we have excellent preliminary human data to suggest that
68Ga-CM500 can accurately identify thrombus in the heart. The purpose of this CRP grant is to provide funding
to 1) file an IND for 68Ga-CM500, 2) perform safety, pharmacokinetic, and dosimetry evaluations in healthy
volunteers, and 3) obtain proof of concept data that 68Ga-CM500 can detect thrombus in the deep veins and
pulmonary arteries of patients with deep vein thrombosis and/or pulmonary embolism.
The probe 68Ga-CM500 displays high affinity for fibrin, fast blood clearance, and high metabolic stability. In rat
and rabbit models it demonstrated an excellent ability to detect thrombus with a high target-to-background ratio.
The goal of this Commercialization Readiness Pilot program is to evaluate 68Ga-CM500, as a tool to
noninvasively diagnose thrombosis in patients. We have already prepared a batch of solid drug substance
precursor...

## Key facts

- **NIH application ID:** 10158327
- **Project number:** 2R44HL156606-05
- **Recipient organization:** COLLAGEN MEDICAL, LLC
- **Principal Investigator:** Valerie Humblet
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $496,849
- **Award type:** 2
- **Project period:** 2021-03-01 → 2023-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10158327

## Citation

> US National Institutes of Health, RePORTER application 10158327, Molecular Imaging Agent to Detect Thrombus (2R44HL156606-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10158327. Licensed CC0.

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