Validation, calibration, and translation of restriction spectrum imaging signal maps to enhance MRI diagnostic capabilities in prostate cancer

Active Project Grant Awarded Last action

Award ID
R01CA279667
Recipient
Awarding agency
Obligated
$6,234,837

Award facts

Assistance listing
93.394 Cancer Detection and Diagnosis Research
Completion date 68% complete
Originally
Place of performance
La Jolla, CA 92093, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

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.

Transactions

Action Obligated Date
Amendment $623,881
Amendment $627,248
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Amendment $627,248
Amendment -$137,005
Amendment $212,535
Amendment -$75,530
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Amendment $408,291
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Amendment $28,698
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Amendment $516,598
Amendment $516,598
Amendment $516,598
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Amendment $616,004
Amendment $616,004
Original award $616,004
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Subawards

Subrecipient Amount Awarded
Cortechs Labs, Inc. Sub: 104,441.33 03/16/2026 Statement of Work Cortechs Labs, dba Cortechs.ai, will support UCSD in all three aims of this project. Throughout the proposal (Aim… $104,441
Cortechs Labs, Inc. Cortechs Labs, dba Cortechs.ai, will support UTHSA in all three aims of this project. Throughout the proposal (Aim 1-3), we will provide processing with our FDA… $28,484
University Of California, San Diego Objective: To calibrate and harmonize prostate RSI data across MRI vendor platforms Explanation of work to be performed: The calibration and harmonization steps… $26,375

Quick answers

Who received award R01CA279667?

R01CA279667 was awarded to University Of California, San Diego by National Cancer Institute (National Institutes of Health) on May 17, 2023.

How much is award R01CA279667 worth?

$6,234,837 has been obligated on R01CA279667.

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