# Safety Assessment of Laser Activated NanoTherapy (LANT) as a Potential Treatment for Veterans with Cutaneous Squamous Cell Carcinomas

> **NIH VA I01** · VETERANS HEALTH ADMINISTRATION · 2022 · —

## Abstract

Cutaneous squamous cell carcinomas (cSCC) are responsible for more than twice the number of skin cancer
deaths than melanoma, representing up to 50% of all skin cancers. Approximately 700,000 cases are
diagnosed annually in the United States, but Veterans have a higher risk for cSCC because of age and
extensive exposures during the line of duty to UV radiation and arsenic-based chemical warfare agents. Most
cSCC can be successfully treated by surgical excision or Mohs Micrographic Surgery (Mohs); however, a
subset of cSCC cases result in locoregional recurrence, metastases, and death. The poor prognoses for many
Veterans with cSCC result in a substantial unmet need for better treatment options, especially for those who
request a non-surgical treatment option or who are not a candidate for surgery because they are
immunosuppressed or have other comorbidities. The novel technology in this proposal, Laser-Activated
NanoTherapy (LANT), can meet this unmet need for an alternative to radiation when surgery is not an option.
LANT is a thermal ablation platform therapy using near-infrared laser excitation of gold nanorods (AuNRs)
that generates enough heat to induce site-specific cellular death. The innovation of our technology is the
nanoparticle design and the resulting therapeutic outcomes. In our preliminary studies, LANT demonstrated
(a) 100% SCC cell death at the highest concentration on our dose-escalation curve in vitro, and (b) complete
tumor regression after one treatment iteration with clear tumor margins in subcutaneously-xenografted
squamous cell carcinoma in mice, compared to three control groups, no-treatment, laser-only, and AuNRs-
only. Based on these findings, we propose a study designed to demonstrate that LANT is safe and translate
LANT from bench to bedside with three aims. For Aim 1, we will demonstrate the biodistribution, clearance,
and safety of AuNRs in a murine tumor model and a domestic swine model
to acquire PK/PD data
using ICP-
MS, hematology/serology, and histology. We will verify the distribution of AuNRs, heat generation, and LANT-
induced injury to the tumor, tumor margins, and surrounding tissues using 3D ultrasound imaging, K-type
thermocouples, and IR thermographic cameras. We will also validate LANT safety at different laser output
powers by capturing gross appearance changes with photographic imaging and analyzing morphological
changes with histological evaluation of tumors, tumor margins, and surrounding tissues. We will work with our
FDA consultant and seven (7) clinical partners to obtain FDA and IRB approvals before beginning the pilot
study. For Aim 2, we will recruit Veterans (n = 10) who have biopsy-confirmed local, low-risk cSCC. Veterans
will receive 3-D ultrasound-guided injections of AuNRs during LANT. Veterans will also receive the standard
of care Mohs Micrographic Surgery to confirm clear tumor margins 21 days after LANT. We will employ an
adaptive Bayesian Continual Reassessment Method (CRM) to deter...

## Key facts

- **NIH application ID:** 10483631
- **Project number:** 1I01CX002353-01A2
- **Recipient organization:** VETERANS HEALTH ADMINISTRATION
- **Principal Investigator:** Hadiyah-Nicole Green
- **Activity code:** I01 (R01, R21, SBIR, etc.)
- **Funding institute:** VA
- **Fiscal year:** 2022
- **Award amount:** —
- **Award type:** 1
- **Project period:** 2022-10-01 → 2026-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10483631

## Citation

> US National Institutes of Health, RePORTER application 10483631, Safety Assessment of Laser Activated NanoTherapy (LANT) as a Potential Treatment for Veterans with Cutaneous Squamous Cell Carcinomas (1I01CX002353-01A2). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10483631. Licensed CC0.

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