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Radiotracer-Based Imaging for Quantitative Assessment of Skeletal Muscle Perfusion in Peripheral Artery Disease

Award Number: R01HL135103
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 01/13/2017
PERIOD OF PERFORMANCE END DATE: 08/31/2028

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Radiotracer-Based Imaging for Quantitative Assessment of Skeletal Muscle Perfusion in Peripheral Artery Disease - PROJECT SUMMARY Patients with lower extremity peripheral artery disease (PAD) are at increased risk of lifestyle limiting claudication, ulceration, amputation, and death. Despite this knowledge, an ongoing challenge for the vascular community is the lack of a standard non-invasive test for quantifying regional abnormalities in skeletal muscle perfusion in PAD. Our laboratory has been at the forefront of translating nuclear perfusion imaging techniques to patients with PAD and demonstrated the potential prognostic value of these methods for prediciting clinical outcomes. Specifically, in the prior funding period of this award, we clinically translated a single photon emission computed tomography (SPECT)/CT imaging approach from pigs with limb ischemia to patients with PAD and demonstrated that SPECT/CT perfusion imaging measures were repeatable in patients, detected regional abnormalities in resting perfusion of the lower extremities, assessed perfusion defects that corresponded with the level of future amputation, and quantified revascularization-induced regional improvements in relative perfusion that were associated with risk of amputation after endovascular therapy. We then developed and validated a dynamic positron emission tomography (PET) perfusion imaging approach using fluorine-18 (18F)-sodium fluoride (NaF), a radionuclide traditionally used for molecular imaging of bone and vascular microcalcification. Dynamic 18F-NaF PET imaging revealed utility for quantifying regional, absolute measures of muscle perfusion (i.e., ml/min/100g) in pigs and PAD patients with limb ischemia that coincided with microvascular remodeling in pig skeletal muscle and symptom severity in PAD patients. The goal of this proposal is to leverage the novel PET perfusion imaging method developed in the prior funding period to optimize regional evaluation of absolute measures of skeletal muscle perfusion in PAD patients undergoing endovascular revascularization. To accomplish this goal, in Aim 1, we will validate dynamic 18F- NaF PET perfusion imaging as an approach for monitoring ischemia-induced alterations in skeletal muscle morphology and mitochondrial function using a newly developed porcine model of chronic limb-threatening ischemia (CLTI). In Aim 2, we will establish a healthy clinical database for 18F-NaF PET perfusion measures and compare these perfusion measures to standard indices of macro- and microvascular disease in patients with PAD. In Aim 3, we will quantify absolute changes in regional calf muscle perfusion in response to revascularization procedures in patients with PAD using dynamic PET imaging, and evaluate the relationship between regional perfusion responses and clinical outcomes. These studies are designed to pre-clinically validate the utility of dynamic PET perfusion imaging for evaluating adverse remodeling of skeletal muscle and test the clinical efficacy of this method for monitoring regional responses to endovascular treatment and predicting clinical outcomes.


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 = $597,645 )
2026	2026	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Cardiovascular Diseases Research	000	8	3/5/2026	NON-COMPETING CONTINUATION	$579,351
2026	2026	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Cardiovascular Diseases Research	001	8	3/24/2026	NON-COMPETING CONTINUATION	$18,294
														Subtotal = $597,645

Issue Date FY: 2025 ( Subtotal = $661,187 )
2025	2025	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Cardiovascular Diseases Research	002	7	8/5/2025	NON-COMPETING CONTINUATION	$66,120
2025	2025	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Cardiovascular Diseases Research	000	7	12/27/2024	NON-COMPETING CONTINUATION	$595,067
2025	2021	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Cardiovascular Diseases Research	001	5	3/19/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $661,187

Issue Date FY: 2024 ( Subtotal = $686,893 )
2024	2024	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Cardiovascular Diseases Research	000	6	12/29/2023	COMPETING CONTINUATION	$686,893
														Subtotal = $686,893

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2021	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Cardiovascular Diseases Research	000	5	1/20/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $337,921 )
2021	2021	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Cardiovascular Diseases Research	000	5	5/27/2021	NON-COMPETING CONTINUATION	$337,921
														Subtotal = $337,921

Issue Date FY: 2020 ( Subtotal = $338,248 )
2020	2020	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Cardiovascular Diseases Research	001	4	1/31/2020	NON-COMPETING CONTINUATION	$16,913
2020	2020	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Cardiovascular Diseases Research	000	4	12/30/2019	NON-COMPETING CONTINUATION	$321,335
														Subtotal = $338,248

Issue Date FY: 2019 ( Subtotal = $338,570 )
2019	2019	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Cardiovascular Diseases Research	003	3	12/31/2018	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$338,570
2019	2019	RESEARCH INSTITUTE AT NATIONWIDE CHILDREN'S HOSPITAL	700 CHILDRENS DR	COLUMBUS	OH	43205	FRANKLIN	USA	Cardiovascular Diseases Research	004	3	2/5/2019	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$512,709
2019	2018	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Cardiovascular Diseases Research	000	2	12/19/2018	NON-COMPETING CONTINUATION	$0
2019	2018	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Cardiovascular Diseases Research	002	2	12/27/2018	NON-COMPETING CONTINUATION	-$418,750
2019	2017	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Cardiovascular Diseases Research	001	1	12/27/2018	NEW	-$93,959
														Subtotal = $338,570

Issue Date FY: 2018 ( Subtotal = $418,750 )
2018	2018	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Cardiovascular Diseases Research	000	2	12/25/2017	NON-COMPETING CONTINUATION	$410,375
2018	2018	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Cardiovascular Diseases Research	001	2	6/23/2018	NON-COMPETING CONTINUATION	$8,375
														Subtotal = $418,750

Issue Date FY: 2017 ( Subtotal = $418,750 )
2017	2017	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Cardiovascular Diseases Research	000	1	1/12/2017	NEW	$418,750
														Subtotal = $418,750

Grand Total All Awards = $3,797,964

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Radiotracer-Based Imaging for Quantitative Assessment of Skeletal Muscle Perfusion in Peripheral Artery Disease

Award Number: R01HL135103

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 01/13/2017

PERIOD OF PERFORMANCE END DATE: 08/31/2028

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