# TOWARDS COMMERCIALIZATION OF T1p MRI FOR OSTEOARTHRITIS (OA) DIAGNOSIS AND TREATMENT MONITORING

> **NIH NIH R43** · CADENZAMED, LLC · 2020 · $224,997

## Abstract

Abstract
 Osteoarthritis (OA) is a debilitating disease that results in cartilage loss and pain, and has a significant impact
on morbidity and healthcare costs worldwide. There is an unmet need for a therapeutic intervention that limits
the progression of OA. Many therapeutic targets are being pursued by pharmaceutical companies to develop
successful disease modifying therapy for OA. However, the major impediment in the development of effective
OA therapeutics is the absence of a reliable index for measuring disease modifying effects of drug candidates
in clinical trials.
 Radiographic measures of Joint Space Narrowing (JSN), currently used endpoints in clinical trials, lack
sensitivity to soft tissues and thus are unable to detect early cartilage abnormalities. Thus, JSN may not be
clinically relevant as a primary endpoint for measuring efficacy of a disease modifying agent. Therefore, there is
a critical need for a validated noninvasive imaging biomarker for the early diagnosis of OA and to measure the
response of a drug to develop novel therapeutics to improve OA patient care and reduce healthcare costs.
 A T1r MRI method, developed and patented by Dr. Reddy’s group at the University of Pennsylvania, has
been shown to detect early cartilage abnormalities in OA patients including the finding that T1ρ values are
elevated in early, moderate and advanced stages of OA (in a limited number of patients), when compared with
corresponding asymptomatic subjects. However, for 3D T1r MRI to be a viable commercial product for routine
clinical applications, one needs to address the following two challenges: i) the variability of 3D T1r MRI across
MRI vendors; and II) the lack of validation of the 3D T1r MRI imaging biomarker.
 We propose to develop a robust clinically validated commercial 3D T1r MRI product for routine clinical
diagnosis of OA and for measuring the progression of the disease and its response to therapy in OA clinical
trials. Towards that goal, we propose to address the first challenge of commercialization by establishing the
clinically relevant reproducibility error in T1ρ in healthy volunteers within and across 3T MRI scanners to generate
an evidence-based foundation to move to Phase II for clinical validation of the biomarker. Once the variability of
3D T1r MRI has been established at the end of the proposed study, we will engage, in Phase II, to clinically
validate 3D T1r MRI imaging biomarker using the standard of practice of OA disease diagnosis and progression,
Kellgren-Lawrence (KL) grade (a gold standard), in a well powered clinical study. In addition, we will initiate
collaborative OA clinical trials with Pharma/CRO during Phase II and will begin discussions with regulatory
agencies to secure a CPT code for 3D T1r MRI for early diagnosis of OA.

## Key facts

- **NIH application ID:** 10003500
- **Project number:** 1R43AR076265-01A1
- **Recipient organization:** CADENZAMED, LLC
- **Principal Investigator:** SUSANTA K SARKAR
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $224,997
- **Award type:** 1
- **Project period:** 2020-05-01 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10003500

## Citation

> US National Institutes of Health, RePORTER application 10003500, TOWARDS COMMERCIALIZATION OF T1p MRI FOR OSTEOARTHRITIS (OA) DIAGNOSIS AND TREATMENT MONITORING (1R43AR076265-01A1). Retrieved via AI Analytics 2026-06-24 from https://api.ai-analytics.org/grant/nih/10003500. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*