# In vivo endobronchial OCT for IPF diagnosis and therapy response assessment

> **NIH NIH R01** · MASSACHUSETTS GENERAL HOSPITAL · 2024 · $766,417

## Abstract

Project Summary
Idiopathic pulmonary fibrosis (IPF) is a progressive, fatal form of interstitial lung disease (ILD), affecting
100,000 per year in the US, with a 3-year survival rate of 50% and a large socio-economic healthcare burden.
Early, accurate diagnosis is essential to determine treatment, which differs drastically between IPF and other
ILDs. Initiating treatment as early as possible is a key strategy to prevent irreversible loss of lung function and
maximize patient outcomes. Definitive IPF diagnosis can be made by CT in ~50% of cases when classic
imaging features are present, which must include peripheral honeycombing. However, CT is unable to resolve
features < 2 mm, including microscopic honeycombing present in ~50% of cases, which includes nearly all
cases of early IPF. When CT fails to diagnose IPF, surgical lung biopsy (SLBX) is required to obtain tissue for
microscopy, but has high morbidity and mortality risks. Evaluating therapeutic response is also critical for
deciding which patients should stay on expensive, poorly-tolerated therapy and which should not. IPF
microscopic features are indicators of disease progression, but cannot be assessed over time with either CT or
SLBX. Our objective is to meet this critical need by clinically validating endobronchial optical
coherence tomography (EB-OCT) for early microscopic IPF diagnosis and therapy response
assessment. EB-OCT provides rapid 3D imaging with microscopic resolutions (< 10 μm) well beyond CT
capabilities. We have developed thin OCT catheters that can bronchoscopically access the subpleural lung,
assessing 100x more lung volume at more distinct sites than SLBX without the associated risks. We have
shown in a pilot study of 18 ILD patients that in vivo EB-OCT can detect microscopic honeycombing not visible
with CT. Our data suggest that EB-OCT can differentiate IPF from non-IPF ILDs with near perfect accuracy as
compared with SLBX. In order to validate this conclusively, we will conduct the proposed studies: In Aim 1, we
will use our ex vivo EB-OCT and matched histology database to determine accuracy for IPF diagnosis ex vivo
in an independent multi-reader, blinded assessment and validate automated methods to quantify individual IPF
microscopic features known to indicate disease progression against histology. In Aim 2, we will translate these
findings to a multi-centered prospective clinical study. We will determine the accuracy of EB-OCT for IPF
diagnosis in patients with non-diagnostic CT undergoing diagnostic SLBX in an independent multi-reader,
blinded assessment. We will then repeat EB-OCT in IPF patients, 6 months later, at the same locations and
quantify EB-OCT features at each time point using the automated methods validated in Aim 1. We will
compare EB-OCT changes amongst patients on and off therapy and against changes in lung function testing
and survival. The accomplishment of these studies will eliminate a major obstacle in IPF by validating EB-OCT
as a minimally...

## Key facts

- **NIH application ID:** 10847332
- **Project number:** 5R01HL152075-05
- **Recipient organization:** MASSACHUSETTS GENERAL HOSPITAL
- **Principal Investigator:** Lida P Hariri
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $766,417
- **Award type:** 5
- **Project period:** 2020-06-01 → 2026-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10847332

## Citation

> US National Institutes of Health, RePORTER application 10847332, In vivo endobronchial OCT for IPF diagnosis and therapy response assessment (5R01HL152075-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10847332. Licensed CC0.

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