# Novel Fluorescent Diagnostic Agents for Detection, Staging, andIntraoperative Imaging of Tumors

> **NIH NIH R44** · ONCONANO MEDICINE, INC. · 2020 · $790

## Abstract

Abstract
The goal of this project is to develop IV injectable fluorescent agents for use in intraoperative
imaging of peritoneal metastatic tumors. Significance: Peritoneal metastatic cancers have an
incidence of 250,000/per year in the US and are primarily treated with surgery. Complete surgical
tumor resection is a gold-standard treatment goal that can increase the 5-year patient survival to
50%, whereas incomplete tumor resection (<2mm) could drastically reduce the survival to a mere
few months. Current clinical imaging technologies such as PET, MRI and CT have limitations for
guiding cancer surgery including inability to be used intraoperatively due to safety associated with
ionizing radiation, as well as limitations on sensitivity and tumor specificity especially for lesions
smaller than 10mm. Conventional fluorescent molecular probes in development typically target
tumor proteins and are limited in imaging the heterogeneous onco-geno-phenotypes of peritoneal
metastasis that have multiple tissues of origin and vary in protein expression levels. In order to
reduce incomplete tumor resection and improve survival, there is an urgent need for clear visual
contrast imaging agents that enable more precise and specific detection of peritoneal metastasis
tumors intraoperatively and in real-time. Hypothesis: OncoNano’s approach of targeting tumor
acidosis which is ubiquitously expressed as a cancer biomarker across tumors, coupled with
OncoNano’s ultra-sensitive pH fluorescent digital sensors, provides a broad based approach to
image the heterogeneous peritoneal metastasis with high specificity and sensitivity. Preliminary
Data: We have demonstrated that OncoNano’s fluorescent agents image tumors across a variety
of solid tumor types (14 tested to date), including peritoneal metastasis to submillimeter precision
in SCID mouse models. OncoNano’s agents provided a digital (ON-OFF) response which offered
clear tumor delineation, and lower detection limits (>10x) compared with state of the art PET-FDG
imaging. Surgical tumor resection using OncoNano imaging agent showed significant (40-50%)
survival benefit in SCID mouse models compared with conventional white light based surgery.
Specific Aims: The scientific aims of this project will enable OncoNano to clinically translate, the
ultrasensitive pH probes and develop it from the lab bench through to establishing reproducible
manufacturing of a stable formulation, to establishing safety and pharmacology, for an FDA IND
filing. The specific aims in the SBIR Phase I, addresses the nanoprobe stability requirement, and
addresses the nanoprobe sensitivity and specificity requirement in in-vivo models. The specific
aims in Phase 2 of the project addresses the critical milestones on the path to clinical translation
including- the scale-up requirement to meet the GLP and human testing needs, a demonstration
of product safety in GLP in-vivo studies, culminating in an IND filing with the FDA.

## Key facts

- **NIH application ID:** 10241560
- **Project number:** 3R44CA217528-03S1
- **Recipient organization:** ONCONANO MEDICINE, INC.
- **Principal Investigator:** Ravi Srinivasan
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $790
- **Award type:** 3
- **Project period:** 2017-09-21 → 2021-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10241560

## Citation

> US National Institutes of Health, RePORTER application 10241560, Novel Fluorescent Diagnostic Agents for Detection, Staging, andIntraoperative Imaging of Tumors (3R44CA217528-03S1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10241560. Licensed CC0.

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