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Validation, Calibration, and Translation of Restriction Spectrum Imaging Signal Maps to enhance MRI diagnostic capabilities in Prostate Cancer

Award Number: R01CA279667
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/17/2023
PERIOD OF PERFORMANCE END DATE: 06/30/2028

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Validation, Calibration, and Translation of Restriction Spectrum Imaging Signal Maps to enhance MRI diagnostic capabilities in Prostate Cancer - Project Summary/Abstract Prostate cancer affects nearly 1 in 7 men in the United States yet the diagnosis of early aggressive cancer remains elusive at the expense of many unnecessary biopsies, delay in diagnosis from biopsy sampling error, or the diagnosis of indolent disease. In order make a diagnose clinically significant prostate cancer, there is an urgent need find an imaging modality that can be implemented uniformly, yet also provide clinical utility. MRI- guided prostate biopsy has rapidly become a common modality to perform prostate biopsy; however, limited emphasis has been placed on the quality and accuracy of the image acquisition. Our proposal supports an academic-industry partnership to develop and imaging biomarker that could revolutionize how prostate cancer is diagnosed and monitored by using restriction spectrum imaging (RSI)-MRI. We seek to improve the operating characteristics of prostate MRI with a novel, non-invasive method of a short- duration, targeted magnetic RSI-MRI sequences then undergo FDA-cleared, class II post-processing software (OnQ Prostate) to attribute values to suspicious areas of the prostate. RSI-MRI employs multiple b-value acquisitions with multiple diffusion gradient directions at each b-value to acquire raw data; images are post- processed to isolate the signal from isotropic, restricted water compartments typically found in cancer cells. A resultant “restricted signal map” corresponding to tumor location is derived and quantified functioning as an in vivo biomarker of tumor grade and enhances tumor conspicuity for reader detection. In Aim 1, weseek to validate our previous findings regarding the operating characteristics of the RSM values and its association with clinically significant prostate cancer (grade group 2 or higher). We will use a non-randomized, single arm clinical trial to investigate both PI-RADS scores with and without the RSM values. In Aim 2, we see to calibrate the RSM map values across manufacturers(Siemens, GE, and Phillips MRI scanners). We will use a two-scan approach which will invite a sample of men with a range of PI-RADS values to undergo a research reference scan after they have undergone their standard of care scan within one of three locations housing a specific MRI vendor. The two scans will be compared and used to calibrate the RSM values using several calibration and normalization techniques with targeted biopsy results. In some men that do undergo prostatectomy, we will further make a mold of the prostate using the preoperative MRI then perform whole-mount sectioning, scanning, and alignment with RSI-MRI to obtain accurate reads of normal and cancer areas. In Aim 3, we will compare RSM to currently available FDA-approved biomarkers and clinical risk to determine clinical utility. In the proposed project, we seek to improve specificity of prostate MRI using RSI. Specific deliverables will include the ability to amend the standard radiological reporting system (PI-RADS) withspecific RSM output vales. We seek to validate the restricted signal maps between vendors and provide clinical assessment tools demonstrating a measurement of clinical utility.


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 = $623,881 )
2026	2026	UNIVERSITY OF CALIFORNIA, SAN DIEGO	9500 GILMAN DR	LA JOLLA	CA	92093	SAN DIEGO	USA	Cancer Detection and Diagnosis Research	000	5	7/2/2026	NON-COMPETING CONTINUATION	$623,881
														Subtotal = $623,881

Issue Date FY: 2025 ( Subtotal = $627,248 )
2025	2025	UNIVERSITY OF CALIFORNIA, SAN DIEGO	9500 GILMAN DR	LA JOLLA	CA	92093	SAN DIEGO	USA	Cancer Detection and Diagnosis Research	003	4	7/30/2025	NON-COMPETING CONTINUATION	$627,248
2025	2024	UNIVERSITY OF CALIFORNIA, SAN DIEGO	9500 GILMAN DR	LA JOLLA	CA	92093	SAN DIEGO	USA	Cancer Detection and Diagnosis Research	001	3	12/17/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$408,291
2025	2024	THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO	7703 FLOYD CURL DR	SAN ANTONIO	TX	78229	BEXAR	USA	Cancer Detection and Diagnosis Research	000	2	12/17/2024	NON-COMPETING CONTINUATION	-$408,291
2025	2024	THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO	7703 FLOYD CURL DR	SAN ANTONIO	TX	78229	BEXAR	USA	Cancer Detection and Diagnosis Research	002	2	3/18/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $627,248

Issue Date FY: 2024 ( Subtotal = $545,296 )
2024	2024	THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO	7703 FLOYD CURL DR	SAN ANTONIO	TX	78229	BEXAR	USA	Cancer Detection and Diagnosis Research	000	2	3/26/2024	NON-COMPETING CONTINUATION	$516,598
2024	2024	THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO	7703 FLOYD CURL DR	SAN ANTONIO	TX	78229	BEXAR	USA	Cancer Detection and Diagnosis Research	001	2	4/18/2024	NON-COMPETING CONTINUATION	$28,698
														Subtotal = $545,296

Issue Date FY: 2023 ( Subtotal = $616,004 )
2023	2023	UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER OF SAN ANTONIO	7703 FLOYD CURL DR	SAN ANTONIO	TX	78229	BEXAR	USA	Cancer Detection and Diagnosis Research	000	1	5/17/2023	NEW	$616,004
														Subtotal = $616,004

Grand Total All Awards = $2,412,429

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Validation, Calibration, and Translation of Restriction Spectrum Imaging Signal Maps to enhance MRI diagnostic capabilities in Prostate Cancer

Award Number: R01CA279667

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 05/17/2023

PERIOD OF PERFORMANCE END DATE: 06/30/2028

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