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Novel noninvasive diagnostic technology for dynamic imaging of mitochondrial bioenergetics in breast cancer patients

Award Number: R41CA210823
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/16/2016
PERIOD OF PERFORMANCE END DATE: 04/30/2021

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Novel noninvasive diagnostic technology for dynamic imaging of mitochondrial bioenergetics in breast cancer patients - Summary Breast cancer is the second most common and the major cause of cancer-related death of women in the USA. The last decade has witnessed major advancement of therapeutic drugs and tools, while noninvasive diagnostic imaging tools to measure interventions received much less attention. Currently, the mainstay of noninvasive imaging in breast cancer relies primarily on anatomic imaging. Metabolic imaging using FDG PET is a successful diagnostic tool in several types of cancer, but not in the setting of breast cancer. The last decade has also witnessed the revival of interest in the role of mitochondria in tumor invasiveness, and as regulators of cytotoxicity of first-line chemotherapy agents. Yet, current tools for noninvasive investigations and diagnostics of the mitochondrial function in cancer patients are limited to SPECT imaging agents. Our recent preclinical studies provided compelling evidence for the capacity of the PET imaging voltage sensor 18F- fluorobenzyltriphenylphosphonium (FBnTP), developed by the PI laboratory, to potentially improve management of breast cancer. This includes: (1) improved early detection of early-stage, small, vascularized breast lesion with better functional and spatial resolution compared to FDG PET and SPECT imaging; (2) Accurate 3D mapping of tumor proliferation, an important prognostic factor in the clinical setting; and (3) very early molecular-level detection of treatment response, directly at the core mechanism of cytotoxicity of first-line chemotherapy agents. The technology supporting these utilities is based on our studies which demonstrate that cellular uptake of FBnTP is directly proportional to the mitochondrial membrane potential (ΔΨm) of a cell. ΔΨm is the most comprehensive physiological endpoint of the organelle bioenergetics. ΔΨm is a unique target that enables attaining the above goals. ΔΨm is significantly greater in certain types of malignant cells, including those of breast origin, compared to normal cells, resulting in a preferential accumulation of FBnTP in tumor mass, compared to healthy parenchyma. ΔΨm increases in highly proliferating breast cancer cells, whereas collapse of ΔΨm coincides with the initiation of the irreversible phase of the apoptotic cell death as induced by many first-line chemotherapy agents in the breast cancer setting. The goal of this STTR Phase 1 study is to establish proof of concept in patient samples under the approved IRB that FBnTP is an effective imaging technology to detect breast lesions in women; a prerequisite for future feasibility studies of FBnTP as a surrogate marker of breast tumor invasiveness and response to therapeutic interventions. To improve commercial competitiveness, FBnTP imaging will be carried out using breast- dedicated positron emission mammogram (PEM), a less costly technology, compared to PET, CT and MRI and of better spatial resolution than PET.


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: 2022 ( Subtotal = $0 )
2022	2016	MITOLUMINATE LLC	3009 WOODVALLEY DRIVE	BALTIMORE	MD	21208	BALTIMORE	USA	Cancer Detection and Diagnosis Research	000	2	11/30/2021	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2016	MITOLUMINATE LLC	3009 WOODVALLEY DRIVE	BALTIMORE	MD	21208	BALTIMORE	USA	Cancer Detection and Diagnosis Research	000	2	9/10/2020	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2016	MITOLUMINATE LLC	3009 WOODVALLEY DRIVE	BALTIMORE	MD	21208	BALTIMORE	USA	Cancer Detection and Diagnosis Research	000	2	9/4/2019	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $0 )
2018	2016	MITOLUMINATE LLC	3009 WOODVALLEY DRIVE	BALTIMORE	MD	21208	BALTIMORE	USA	Cancer Detection and Diagnosis Research	000	2	7/25/2018	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = $0 )
2017	2016	MITOLUMINATE LLC	3009 WOODVALLEY DRIVE	BALTIMORE	MD	21208	BALTIMORE	USA	Cancer Detection and Diagnosis Research	001	2	5/23/2017	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$225,000
2017	2016	ROBIN MEDICAL, INC.	3502 GARDENVIEW RD	PIKESVILLE	MD	21208	BALTIMORE	USA	Cancer Detection and Diagnosis Research	000	1	5/23/2017	NEW	-$225,000
														Subtotal = $0

Issue Date FY: 2016 ( Subtotal = $225,000 )
2016	2016	ROBIN MEDICAL, INC	6607 BONNIE RIDGE DRIVE	BALTIMORE	MD	21209	BALTIMORE CITY	USA	Cancer Detection and Diagnosis Research	000	1	9/16/2016	NEW	$225,000
														Subtotal = $225,000

Grand Total All Awards = $225,000

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Novel noninvasive diagnostic technology for dynamic imaging of mitochondrial bioenergetics in breast cancer patients

Award Number: R41CA210823

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/16/2016

PERIOD OF PERFORMANCE END DATE: 04/30/2021

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