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Ex vivo intraoperative surgical basal margin analysis in head and neck cancer resection: clinical validation

Award Number: R01DE033449
ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/02/2024
PERIOD OF PERFORMANCE END DATE: 03/31/2029

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Ex vivo intraoperative surgical basal margin analysis in head and neck cancer resection: clinical validation - Ex vivo intraoperative surgical basal margin analysis in head and neck cancer resection: clinical validation In a clinical collaboration with the University Medical Center Groningen (UMCG), Netherlands—led by Oral and Maxillofacial Surgeon, Dr. Witjes—we will advance and clinically test an intraoperative dual-aperture fluorescence ratio (dAFR) imaging system and an automated data analysis (ADA) approach that can analyze an entire resected-tissue basal margin in <1 min for head and neck squamous cell cancer (HNSCC) resection surgery. This is a significant improvement upon currently used frozen-section histopathology that requires >30 min and can only be done for a limited number of resected-tissue locations. The project will specifically focus on improving detection and localization of inadequate (positive and close) basal surgical margins, critical for patient survival. Over 3 million individuals across the globe are diagnosed with head and neck squamous cell carcinoma (HNSCC) each year. At present, surgical intervention is the primary treatment; however, owing to the complexity of the anatomy in the head and neck, >20% of procedures may fail to attain tumor-free surgical basal margins (defined as greater than 5 mm of healthy tissue surrounding the deep edge of the resected tumor). Unfortunately, because of slow resected-tissue processing, patients are often sent home before margins are fully assessed. While some patients can return for re-resection, for many, health concerns or substantial post-resection reconstruction surgeries make re-resection infeasible, and radiotherapy and/or chemoradiotherapy is needed. Patients with inadequate margins have <15% chance of surviving for 5 years post-surgery, compared to a >80% chance of survival for patients with free margins and no metastatic disease. Before dAFR imaging and surgery, patients are injected with a fluorescent epidermal growth factor receptor (EGFR)-targeted antibody, and intraoperative dAFR images of resected basal margins are taken and analyzed. Our preliminary results from a proof-of-concept dAFR imaging system indicate almost perfect detection rate of inadequate as well as clear margins. In this project, we propose necessary imaging system upgrades and to develop an automated data analysis to remove the need for clinical expert manual segmentation of images. The proposed approach will be validated and tested against state-of-the-art surgical guidance methods in an 80-patient clinical study at UMCG, in terms of detection and localization of inadequate basal margins through ROC and LROC assessments.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $483,132 )
2026	2026	ILLINOIS INSTITUTE OF TECHNOLOGY	10 W 35TH ST	CHICAGO	IL	60616	COOK	USA	Oral Diseases and Disorders Research	001	3	5/11/2026	NON-COMPETING CONTINUATION	$283,003
2026	2026	ILLINOIS INSTITUTE OF TECHNOLOGY	10 W 35TH ST	CHICAGO	IL	60616	COOK	USA	Oral Diseases and Disorders Research	002	3	5/27/2026	SUPPLEMENT FOR EXPANSION	$200,129
2026	2025	ILLINOIS INSTITUTE OF TECHNOLOGY	10 W 35TH ST	CHICAGO	IL	60616	COOK	USA	Oral Diseases and Disorders Research	000	2	3/6/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $483,132

Issue Date FY: 2025 ( Subtotal = $532,573 )
2025	2025	ILLINOIS INSTITUTE OF TECHNOLOGY	10 W 35TH ST	CHICAGO	IL	60616	COOK	USA	Oral Diseases and Disorders Research	001	2	5/8/2025	NON-COMPETING CONTINUATION	$53,256
2025	2025	ILLINOIS INSTITUTE OF TECHNOLOGY	10 W 35TH ST	CHICAGO	IL	60616	COOK	USA	Oral Diseases and Disorders Research	000	2	4/18/2025	NON-COMPETING CONTINUATION	$479,317
														Subtotal = $532,573

Issue Date FY: 2024 ( Subtotal = $558,370 )
2024	2024	ILLINOIS INSTITUTE OF TECHNOLOGY	10 W 35TH ST	CHICAGO	IL	60616	COOK	USA	Oral Diseases and Disorders Research	000	1	4/2/2024	NEW	$558,370
														Subtotal = $558,370

Grand Total All Awards = $1,574,075

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Ex vivo intraoperative surgical basal margin analysis in head and neck cancer resection: clinical validation

Award Number: R01DE033449

ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 04/02/2024

PERIOD OF PERFORMANCE END DATE: 03/31/2029

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