# PET Tracer for Imaging of Lung Inflammation

> **NIH NIH R01** · WASHINGTON UNIVERSITY · 2024 · $673,682

## Abstract

Abstract. Lung transplantation is a well-established surgical intervention in advanced stages of the
disease in pulmonary medicine. Despite improvements in surgical procedures and
immunosuppressive therapeutic paradigms, the median survival rate continues to be 6 years.
Literature precedents show that chronic lung allograft dysfunction (CLAD) is the most significant barrier
to long-term survival of lung transplantation. However, prediction and early diagnosis of CLAD using
current techniques continues to be problematic due to lower sensitivity (HRCT) and specificity
(circulating biomarkers). Currently, the reference standard to detect acute rejection is a
histopathological grading of transbronchial biopsies (TBBs), however, it is an invasive technique with
several limitations (bleeding, inconsistent outcomes, inherent risks associated with repetitive
procedures) including detection at advanced stages of the disease. Therefore, agents capable of
offering non-invasive assessment of chronic rejection after transplantation are a highly desirable
diagnostic nuclear medicine resource, yet continues to be an unmet need. To accomplish this
objective, we have developed a new PET tracer (named as 68Ga-Galuminox), which offers noninvasive
assessment of acute lung injury, and also demonstrates promising higher uptake in alveolar
macrophages of mouse ex vivo lung transplant model of CLAD, and human lung recipients with a
CLAD diagnosis compared to CLAD free subjects. Finally, preliminary 68Ga-Galuminox preclinical
PET imaging in our mouse CLAD model has revealed (at 30 min post tail-vein injection) 2-fold higher
retention in the left transplanted lung with early signs of CLAD when compared to the non-diseased
(untransplanted) right lung. Notably, these observations are also consistent with the observed
activation of macrophages and PMNs in CLAD lungs as measured by flow cytometry that identifies
single cell Galuminox uptake by detecting its native fluorescence. Armed with this supporting
information, aims of our preclinical translational RO1 are: Aim 1: Aim 1: Perform radiation dosimetry
to determine human effective dose equivalent (HED), toxicology studies, and GMP validation runs for
Galuminox to prepare for an IND filing; Aim 2: Perform first-in-human studies using 68Ga-Galuminox:
evaluate dosimetry, biodistribution, safety, and imaging characteristics following a single injection at rest
(n=8, 4 males; 4 females); and Aim 3: To evaluate performance of 68Ga-Galuminox and 18F-FDG for
detection of CLAD pathogenesis in a mouse model of lung transplantation; Aim 3.1: To determine if
68Ga-Galuminox can detect early and late CLAD pathogenesis; Aim 3.2: To determine if 68Ga-
Galuminox can be used to evaluate responses to CLAD treatment; and Aim 3.3: Biochemically
characterize mechanism(s) of location of the 68Ga-Galuminox through cell accumulation, sub-cellular
fractionation studies, pharmacokinetics, and LPS-induced inflammation either in presence or absence
of ...

## Key facts

- **NIH application ID:** 10915706
- **Project number:** 5R01HL167277-02
- **Recipient organization:** WASHINGTON UNIVERSITY
- **Principal Investigator:** Andrew Eric Gelman
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $673,682
- **Award type:** 5
- **Project period:** 2023-09-01 → 2027-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10915706

## Citation

> US National Institutes of Health, RePORTER application 10915706, PET Tracer for Imaging of Lung Inflammation (5R01HL167277-02). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10915706. Licensed CC0.

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