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Bladder Fiducial Markers and Diffusion-MRI to Optimize Bladder Chemo-Radiotherapy

Award Number: R01CA201709
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2016
PERIOD OF PERFORMANCE END DATE: 06/30/2026

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Bladder Fiducial Markers and Diffusion-MRI to Optimize Bladder Chemo-Radiotherapy - DESCRIPTION (provided by applicant) PROJECT ABSTRACT : Management of localized muscle-invasive bladder cancer (MIBC) with radical cystectomy is associated with risk of significant morbidity, perioperative mortality, and decreased quality of life- especially among the growing number of elderly. A less invasive and morbid, but equally effective means of treatment is needed. Multi-modal treatment of MIBC (maximal trans-urethral resection, followed by combined chemo and radiotherapy) is, for well-selected patients, associated with survival outcomes comparable to cystectomy and lower morbidity and mortality, but also offers bladder preservation. However, in the U.S., multi-modal therapy is not common for 3 reasons: First, there is uncertainty among referring urologists as to whether all tumor is visible at time of resection. Second, no currently available radiographic technologies allow reliable visualization of the bladder tumor site and its margins. Furthermore, the bladder is a deformable, mobile structure, whose location, size and shape vary depending on bladder and bowel fullness. This makes it very possible that the whole bladder and tumor site are not consistently treated, and that collateral radiation occurs. Third, we lack a non-invasive (e.g. imaging-based) means by which to assess for local control after treatment. Emerging data suggests that multi-parametric diffusion- weighted and contrast enhanced MRI can detect occult disease, but this has not been robustly validated because imaging findings, to date, could not be definitively correlated with histology of the same bladder site. We describe a means to reliably mark the bladder margins and tumor site to resolve these limitations of multi-modal therapy. To date, no means of marking the bladder walls has proven effective and reliable. We developed a novel fiducial marker design and placement protocol, initially to simply improve targeting of the tumor-site with high-dose radiotherapy. These ultra-small 24K gold markers are placed endoscopically in submucosa around the tumor site at time of pre-treatment maximal resection, and, at the anatomic boundaries of the bladder, to optimize image-guided bladder radiotherapy. To date, we have placed our markers into 32 patients with MIBC at UCSF. They are visible with any imaging modality, including all on- table imaging. They are safe and easy to place, appear not to migrate, and are durable. We propose that our fiducial markers serve to increase high-dose radiotherapy targeting accuracy and lower collateral radiation. The goals of the work proposed here are to (1.) Assess the efficacy, treatment benefit, and generalizability of our markers and placement technique among a larger sample of patients with MIBC; 2. Use our fiducial markers to assess the degree to which urologists may miss occult tumor outside of the main resection area; and 3. Use our markers to assess the positive and negative predictive value (PPV, NPV) of diffusion-MRI to detect occult tumor pre and post-treatment. To accomplish these goals, we will perform 2 separate but complementary studies at UCSF--one in collaboration with Harvard/MGH.


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: 2025 ( Subtotal = $0 )
2025	2022	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	WEST HOLLYWOOD	CA	90048	LOS ANGELES	USA	Cancer Detection and Diagnosis Research	000	6	7/28/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2022	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	WEST HOLLYWOOD	CA	90048	LOS ANGELES	USA	Cancer Detection and Diagnosis Research	000	6	7/23/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	WEST HOLLYWOOD	CA	90048	LOS ANGELES	USA	Cancer Detection and Diagnosis Research	000	6	8/14/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $575,757 )
2022	2022	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	WEST HOLLYWOOD	CA	90048	LOS ANGELES	USA	Cancer Detection and Diagnosis Research	000	6	8/16/2022	NON-COMPETING CONTINUATION	$575,757
														Subtotal = $575,757

Issue Date FY: 2021 ( Subtotal = $612,908 )
2021	2021	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	LOS ANGELES	CA	90048	LOS ANGELES	USA	Cancer Detection and Diagnosis Research	000	5	7/16/2021	NON-COMPETING CONTINUATION	$612,908
														Subtotal = $612,908

Issue Date FY: 2020 ( Subtotal = $702,251 )
2020	2020	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	LOS ANGELES	CA	90048	LOS ANGELES	USA	Cancer Detection and Diagnosis Research	001	4	6/29/2020	NON-COMPETING CONTINUATION	$702,251
2020	2018	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	LOS ANGELES	CA	90048	LOS ANGELES	USA	Cancer Detection and Diagnosis Research	000	3	3/27/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $702,251

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2018	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	LOS ANGELES	CA	90048	LOS ANGELES	USA	Cancer Detection and Diagnosis Research	000	3	8/12/2019	NON-COMPETING CONTINUATION	$0
2019	2018	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	LOS ANGELES	CA	90048	LOS ANGELES	USA	Cancer Detection and Diagnosis Research	001	3	8/30/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $724,638 )
2018	2018	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	LOS ANGELES	CA	90048	LOS ANGELES	USA	Cancer Detection and Diagnosis Research	002	3	8/22/2018	NON-COMPETING CONTINUATION	$724,638
2018	2016	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	000	1	1/9/2018	NEW	-$104,003
2018	2016	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	LOS ANGELES	CA	90048	LOS ANGELES	USA	Cancer Detection and Diagnosis Research	001	2	1/9/2018	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$104,003
														Subtotal = $724,638

Issue Date FY: 2017 ( Subtotal = $177,451 )
2017	2016	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	LOS ANGELES	CA	90048	LOS ANGELES	USA	Cancer Detection and Diagnosis Research	001	2	9/18/2017	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$678,924
2017	2016	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 420	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	000	1	9/15/2017	NEW	-$501,473
														Subtotal = $177,451

Issue Date FY: 2016 ( Subtotal = $672,041 )
2016	2016	UNIVERSITY OF CALIFORNIA-SAN FRANCISCO	BOX 0812	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	000	1	6/29/2016	NEW	$672,041
														Subtotal = $672,041

Grand Total All Awards = $3,465,046

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Bladder Fiducial Markers and Diffusion-MRI to Optimize Bladder Chemo-Radiotherapy

Award Number: R01CA201709

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 07/01/2016

PERIOD OF PERFORMANCE END DATE: 06/30/2026

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