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Quantitative Imaging Biomarker Prospective Validation of Dynamic Contrast-Enhanced MRI as a Metric of Orodental Injury After Radiotherapy (QI-ProVE-MRI)

Award Number: U01DE032168
ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/01/2023
PERIOD OF PERFORMANCE END DATE: 01/31/2028

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Quantitative Imaging Biomarker Prospective Validation of Dynamic Contrast-Enhanced MRI as a Metric of Orodental Injury After Radiotherapy (QI-ProVE-MRI) - PROJECT SUMMARY The rise in human papillomavirus (HPV)-associated head and neck squamous cell carcinoma (HNSCC) has resulted in a rapidly increasing number of younger and healthier patients being treated with locoregional radiation therapy (RT). Although effective in curing the cancer, deleterious RT effects upon organs-at-risk (OARs) such as the salivary glands, swallowing/masticatory muscles, and mandibular bone can result in lifelong sequelae of RT normal tissue injury such as xerostomia, dysphagia, and osteoradionecrosis (ORN), respectively. These long-term sequelae in a patient population with good clinical outcomes and extended life expectancy are increasingly relevant as latent sources of morbidity and mortality in cancer survivorship. Despite this urgency, a standardized staging and monitoring system to identify patients at risk for developing ORN and other morbidities, and to assess the effectiveness of interventional therapies, is not currently available. At our institution, dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) is being integrated into a multimodality clinical algorithm aimed at improving diagnosis, staging, and surveillance of disease and toxicity. DCE-MRI can detect altered bone vascularity associated with bone healing, necrosis, and metastatic involvement, with excellent spatial resolution. Based on our previous NIH-funded research, we hypothesize that an increase in DCE-MRI parameters (i.e., Ktrans/Ve) at any timepoint more than 3 months after RT demonstrates increased risk of normal tissue treatment-related toxicity rates. Our objective is to conduct a biomarker analytic and clinical validation study designed to confirm DCE-MRI parameters as quantitative imaging biomarkers, with the formal deliverable of an application for FDA Biomarker Qualification at study completion, via the following specific aims: 1) Prospective qualification and validation of DCE-MRI Ktrans/Ve as an “FDA BEST-defined” quantitative imaging monitoring biomarker of ORN risk; 2) Investigation of DCE-MRI candidate biomarkers for pre-qualification as quantitative imaging biomarkers of soft-tissue structures; 3) Standardization of image acquisition and open source computational/analytic software for orodental DCE-MRI as a potential component of FDA biomarker qualification. Successful completion of this proposal has the potential to revolutionize the diagnosis and management of late RT-induced morbidities and offer clinicians a reliable and FDA Biomarker Qualification Program validated biomarker to stratify patients at risk for OARs injury after RT, monitor bone and soft tissue injury and subsequent oral morbidity, and manage post-RT care appropriately. This work is particularly relevant to NIDCR’s mission of “advancing fundamental knowledge about dental, oral, and craniofacial health and disease and translate these findings into prevention, early detection, and treatment strategies that improve overall health for all individuals and communities across the lifespan”.


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 = $704,812 )
2026	2026	THE UNIVERISTY OF TEXAS M.D. ANDERSON CANCER CENTER	1515 HOLCOMBE BLVD	HOUSTON	TX	77030	HARRIS	USA	Oral Diseases and Disorders Research	001	4	4/16/2026	NON-COMPETING CONTINUATION	$70,481
2026	2026	THE UNIVERISTY OF TEXAS M.D. ANDERSON CANCER CENTER	1515 HOLCOMBE BLVD	HOUSTON	TX	77030	HARRIS	USA	Oral Diseases and Disorders Research	000	4	2/6/2026	NON-COMPETING CONTINUATION	$634,331
														Subtotal = $704,812

Issue Date FY: 2025 ( Subtotal = $704,812 )
2025	2025	THE UNIVERISTY OF TEXAS M.D. ANDERSON CANCER CENTER	1515 HOLCOMBE BLVD	HOUSTON	TX	77030	HARRIS	USA	Oral Diseases and Disorders Research	000	3	3/11/2025	NON-COMPETING CONTINUATION	$634,331
2025	2025	THE UNIVERISTY OF TEXAS M.D. ANDERSON CANCER CENTER	1515 HOLCOMBE BLVD	HOUSTON	TX	77030	HARRIS	USA	Oral Diseases and Disorders Research	003	3	9/26/2025	NON-COMPETING CONTINUATION	$0
2025	2025	THE UNIVERISTY OF TEXAS M.D. ANDERSON CANCER CENTER	1515 HOLCOMBE BLVD	HOUSTON	TX	77030	HARRIS	USA	Oral Diseases and Disorders Research	002	3	9/17/2025	NON-COMPETING CONTINUATION	$0
2025	2025	THE UNIVERISTY OF TEXAS M.D. ANDERSON CANCER CENTER	1515 HOLCOMBE BLVD	HOUSTON	TX	77030	HARRIS	USA	Oral Diseases and Disorders Research	001	3	5/9/2025	NON-COMPETING CONTINUATION	$70,481
														Subtotal = $704,812

Issue Date FY: 2024 ( Subtotal = $687,801 )
2024	2024	THE UNIVERISTY OF TEXAS MD ANDERSON CANCER CENTER, A COMPONENT OF THE UNIVERISTY OF TEXAS SYSTEM	1515 HOLCOMBE BLVD	HOUSTON	TX	77030	HARRIS	USA	Oral Diseases and Disorders Research	000	2	1/4/2024	NON-COMPETING CONTINUATION	$631,655
2024	2024	THE UNIVERISTY OF TEXAS MD ANDERSON CANCER CENTER, A COMPONENT OF THE UNIVERISTY OF TEXAS SYSTEM	1515 HOLCOMBE BLVD	HOUSTON	TX	77030	HARRIS	USA	Oral Diseases and Disorders Research	002	2	8/14/2024	NON-COMPETING CONTINUATION	$0
2024	2024	THE UNIVERISTY OF TEXAS MD ANDERSON CANCER CENTER, A COMPONENT OF THE UNIVERISTY OF TEXAS SYSTEM	1515 HOLCOMBE BLVD	HOUSTON	TX	77030	HARRIS	USA	Oral Diseases and Disorders Research	001	2	6/14/2024	NON-COMPETING CONTINUATION	$56,146
														Subtotal = $687,801

Issue Date FY: 2023 ( Subtotal = $717,338 )
2023	2023	UNIVERSITY OF TEXAS M. D. ANDERSON CANCER CENTER, THE	1515 HOLCOMBE BLVD	HOUSTON	TX	77030	HARRIS	USA	Oral Diseases and Disorders Research	000	1	2/22/2023	NEW	$717,338
2023	2023	UNIVERSITY OF TEXAS M. D. ANDERSON CANCER CENTER, THE	1515 HOLCOMBE BLVD	HOUSTON	TX	77030	HARRIS	USA	Oral Diseases and Disorders Research	001	1	3/9/2023	NEW	$0
														Subtotal = $717,338

Grand Total All Awards = $2,814,763

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Quantitative Imaging Biomarker Prospective Validation of Dynamic Contrast-Enhanced MRI as a Metric of Orodental Injury After Radiotherapy (QI-ProVE-MRI)

Award Number: U01DE032168

ORGANIZATION: NATIONAL INSTITUTE OF DENTAL AND CRANIOFACIAL RESEARCH

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 04/01/2023

PERIOD OF PERFORMANCE END DATE: 01/31/2028

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