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Image-Guided Intraductal Ablative Procedure for Primary Prevention of Breast Cancer

Award Number: R01CA258314
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 12/14/2021
PERIOD OF PERFORMANCE END DATE: 11/30/2026

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Image-Guided Intraductal Ablative Procedure for Primary Prevention of Breast Cancer - PROJECT ABSTRACT Breast cancer (BC) is the most prevalent cancer and the second-leading cause of cancer-related death for women in the USA. For moderate-risk and, especially, low-risk women with a 1-in-8 lifelong chance of developing BC, there are very few options available to reduce their risk. For high-risk women, prophylactic mastectomy is currently the most effective procedure for preventing BC. This aggressive surgical procedure affects women physically, emotionally, psychologically, aesthetically, and socially. Therefore, there is a need to develop new strategies for primary prevention that focus on high-risk women, but that could also be applied to moderate- and low-risk women. Our overall hypothesis is that the local killing of mammary epithelial cells will be as effective as prophylactic mastectomy in preventing BC, but with minimal side effects. Our preliminary and published data demonstrate that intraductal (ID) injection of a 70% ethanol (EtOH) solution is effective at locally ablating mammary epithelial cells in rodent models and at preventing tumor formation in an aggressive mouse model of BC. The scientific rigor of prior preclinical and clinical research studies as well as clinical use of ID procedures strongly support the translational feasibility of our approach. We have developed a refined EtOH-based solution that contains: tantalum oxide (TaOx) nanoparticles as a high-resolution contrast agent to monitor in vivo filling of ductal trees by CT/X-ray imaging; and ethyl cellulose as gelling agent to further minimize collateral tissue damage. The research objectives of this study are: a) to optimize methods for achieving and in vivo visualizing maximal epithelial ablation; b) to determine the protective benefit and safety concerns of incomplete epithelial ablation; c) to understand the interactions of the components of the ablative solution with the tissue (e.g., fibrosis) and their potential interference with imaging findings (e.g., contrast clearance); and d) To apply this knowledge to establish a clinically compatible procedure for image-guided ablative therapy. To accomplish these, we propose the following two specific aims: Aim 1) To evaluate therapeutic efficacy and safety profile of the ID ablative procedure in rat models of breast cancer; Aim 2) To assess scalability of this image-guided ID ablative procedure in the multi-ductal tree system of a rabbit model. Given the clinical uses of EtOH, diagnostic ID procedures, and clinically compatible imaging protocols, positive results of this study could rapidly lead to the evaluation of image-guided EtOH-based ablation procedure in first-in-human clinical trials for high-risk women. If successful in a high-risk setting, this ID procedure could be offered to moderate- and low-risk women who want to decrease their chance of developing BC and the cancer-associated anxiety that affects their quality of life.


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 = $435,398 )
2026	2026	MICHIGAN STATE UNIVERSITY	426 AUDITORIUM RD RM 360	EAST LANSING	MI	48824	INGHAM	USA	Cancer Cause and Prevention Research	000	5	12/18/2025	NON-COMPETING CONTINUATION	$435,398
														Subtotal = $435,398

Issue Date FY: 2025 ( Subtotal = $544,665 )
2025	2025	MICHIGAN STATE UNIVERSITY	426 AUDITORIUM RD RM 2	EAST LANSING	MI	48824	INGHAM	USA	Cancer Cause and Prevention Research	000	4	12/10/2024	NON-COMPETING CONTINUATION	$490,199
2025	2025	MICHIGAN STATE UNIVERSITY	426 AUDITORIUM RD RM 2	EAST LANSING	MI	48824	INGHAM	USA	Cancer Cause and Prevention Research	001	4	7/2/2025	NON-COMPETING CONTINUATION	$54,466
														Subtotal = $544,665

Issue Date FY: 2024 ( Subtotal = $587,267 )
2024	2024	MICHIGAN STATE UNIVERSITY	426 AUDITORIUM RD RM 2	EAST LANSING	MI	48824	INGHAM	USA	Cancer Cause and Prevention Research	000	3	11/28/2023	NON-COMPETING CONTINUATION	$556,358
2024	2024	MICHIGAN STATE UNIVERSITY	426 AUDITORIUM RD RM 2	EAST LANSING	MI	48824	INGHAM	USA	Cancer Cause and Prevention Research	001	3	4/15/2024	NON-COMPETING CONTINUATION	$30,909
														Subtotal = $587,267

Issue Date FY: 2023 ( Subtotal = $580,151 )
2023	2023	MICHIGAN STATE UNIVERSITY	426 AUDITORIUM RD RM 2	EAST LANSING	MI	48824	INGHAM	USA	Cancer Cause and Prevention Research	000	2	12/9/2022	NON-COMPETING CONTINUATION	$532,792
2023	2023	MICHIGAN STATE UNIVERSITY	426 AUDITORIUM RD RM 2	EAST LANSING	MI	48824	INGHAM	USA	Cancer Cause and Prevention Research	001	2	3/14/2023	NON-COMPETING CONTINUATION	$47,359
														Subtotal = $580,151

Issue Date FY: 2022 ( Subtotal = $598,928 )
2022	2022	MICHIGAN STATE UNIVERSITY	426 AUDITORIUM RD RM 2	EAST LANSING	MI	48824	INGHAM	USA	Cancer Cause and Prevention Research	000	1	12/14/2021	NEW	$598,928
														Subtotal = $598,928

Grand Total All Awards = $2,746,409

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Image-Guided Intraductal Ablative Procedure for Primary Prevention of Breast Cancer

Award Number: R01CA258314

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 12/14/2021

PERIOD OF PERFORMANCE END DATE: 11/30/2026

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