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Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease

Primary Purpose

Peripheral Arterial Disease, Diabetes Mellitus, Critical Limb Ischemia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SPECT/CT perfusion imaging
PET/CT perfusion imaging
Sponsored by
Nationwide Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Peripheral Arterial Disease focused on measuring Radionuclide imaging, Perfusion imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. At least 18 years of age
  2. Evidence of significant obstructive disease for one or multiple lower extremity arteries, as identified by prior ABI, TBI, CT angiography, ultrasound, or MR imaging.

Exclusion Criteria:

  1. Unable to give informed consent or follow-up
  2. Pregnant or nursing
  3. Under the age of 18
  4. No history of peripheral arterial disease

Sites / Locations

  • Nationwide Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SPECT/CT perfusion imaging

PET/CT perfusion imaging

Arm Description

Patients with peripheral arterial disease will have already been scheduled for clinically indicated revascularization procedures of the lower extremity and undergo SPECT/CT imaging as part of the research protocol.

Patients with peripheral arterial disease will have already been scheduled for clinically indicated revascularization procedures of the lower extremity and undergo PET/CT imaging as part of the research protocol.

Outcomes

Primary Outcome Measures

Lower extremity perfusion
The percent or absolute change in perfusion from baseline to post-revascularization will be evaluated.

Secondary Outcome Measures

Wound healing
Rates of wound healing will be documented for 12 months following enrollment into the imaging study.
Limb salvage
Amputation rates will be documented for the 12 months following enrollment into the imaging study.

Full Information

First Posted
August 2, 2018
Last Updated
February 6, 2023
Sponsor
Nationwide Children's Hospital
Collaborators
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT03622359
Brief Title
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Official Title
Radiotracer-Based Imaging for Quantitative Assessment of Angiosome Perfusion Following Lower Extremity Revascularization
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 17, 2017 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital
Collaborators
Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this clinical study is to assess the prognostic value of radiotracer-based perfusion imaging for predicting clinical outcomes in diabetic patients with peripheral arterial disease (PAD) who are undergoing lower extremity revascularization procedures. We hypothesize that radiotracer imaging of the lower extremities will provide a sensitive non-invasive imaging tool for assessing regional abnormalities in foot/calf muscle perfusion and evaluating treatment responses.
Detailed Description
PAD patients (n=200) with peripheral arterial disease (PAD) who are scheduled to undergo lower extremity revascularization procedures will be recruited. Patients will be screened using a standard medical history questionnaire and a physical activity questionnaire. Once their questionnaires are reviewed, individuals who meet inclusion criteria will proceed with standard PAD screening, which will include Ankle-Brachial Indices (ABIs) and Toe-Brachial Indices (TBIs) of both lower extremities. Patients will undergo SPECT/CT or PET/CT perfusion imaging prior to their revascularization procedure and 1-14 days following revascularization. Subjects will receive an intravenous injection of a standard clinical dose of radiotracer for both imaging sessions. A low-dose CT scan will be performed immediately after each SPECT and PET image acquisition for the purposes of attenuation correction and regional analysis of radiotracer uptake. Clinical outcomes will be evaluated for up to 12 months after the imaging study to assess the prognostic value of perfusion imaging for predicting subsequent outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Diabetes Mellitus, Critical Limb Ischemia
Keywords
Radionuclide imaging, Perfusion imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SPECT/CT perfusion imaging
Arm Type
Experimental
Arm Description
Patients with peripheral arterial disease will have already been scheduled for clinically indicated revascularization procedures of the lower extremity and undergo SPECT/CT imaging as part of the research protocol.
Arm Title
PET/CT perfusion imaging
Arm Type
Experimental
Arm Description
Patients with peripheral arterial disease will have already been scheduled for clinically indicated revascularization procedures of the lower extremity and undergo PET/CT imaging as part of the research protocol.
Intervention Type
Diagnostic Test
Intervention Name(s)
SPECT/CT perfusion imaging
Intervention Description
Subjects will receive a standard clinical dose of a radionuclide for perfusion imaging of the lower extremities before and after revascularization procedures.
Intervention Type
Diagnostic Test
Intervention Name(s)
PET/CT perfusion imaging
Intervention Description
Subjects will receive a standard clinical dose of a radionuclide for perfusion imaging of the lower extremities before and after revascularization procedures.
Primary Outcome Measure Information:
Title
Lower extremity perfusion
Description
The percent or absolute change in perfusion from baseline to post-revascularization will be evaluated.
Time Frame
1-2 weeks
Secondary Outcome Measure Information:
Title
Wound healing
Description
Rates of wound healing will be documented for 12 months following enrollment into the imaging study.
Time Frame
1 year
Title
Limb salvage
Description
Amputation rates will be documented for the 12 months following enrollment into the imaging study.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18 years of age Evidence of significant obstructive disease for one or multiple lower extremity arteries, as identified by prior ABI, TBI, CT angiography, ultrasound, or MR imaging. Exclusion Criteria: Unable to give informed consent or follow-up Pregnant or nursing Under the age of 18 No history of peripheral arterial disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mitchel R Stacy, Ph.D.
Phone
614-355-5836
Email
Mitchel.Stacy@nationwidechildrens.org
First Name & Middle Initial & Last Name or Official Title & Degree
Ting-Heng Chou, Ph.D.
Phone
614-355-5828
Email
ting-heng.chou@nationwidechildrens.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchel R Stacy, Ph.D.
Organizational Affiliation
Nationwide Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitchel R Stacy, Ph.D.
Phone
614-355-5836
Email
Mitchel.Stacy@nationwidechildrens.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31482412
Citation
Chou TH, Stacy MR. Clinical Applications for Radiotracer Imaging of Lower Extremity Peripheral Arterial Disease and Critical Limb Ischemia. Mol Imaging Biol. 2020 Apr;22(2):245-255. doi: 10.1007/s11307-019-01425-3.
Results Reference
background
PubMed Identifier
35096884
Citation
Stacy MR. Molecular Imaging of Lower Extremity Peripheral Arterial Disease: An Emerging Field in Nuclear Medicine. Front Med (Lausanne). 2022 Jan 12;8:793975. doi: 10.3389/fmed.2021.793975. eCollection 2021.
Results Reference
background
PubMed Identifier
29748311
Citation
Alvelo JL, Papademetris X, Mena-Hurtado C, Jeon S, Sumpio BE, Sinusas AJ, Stacy MR. Radiotracer Imaging Allows for Noninvasive Detection and Quantification of Abnormalities in Angiosome Foot Perfusion in Diabetic Patients With Critical Limb Ischemia and Nonhealing Wounds. Circ Cardiovasc Imaging. 2018 May;11(5):e006932. doi: 10.1161/CIRCIMAGING.117.006932.
Results Reference
result
PubMed Identifier
31993252
Citation
Chou TH, Atway SA, Bobbey AJ, Sarac TP, Go MR, Stacy MR. SPECT/CT Imaging: A Noninvasive Approach for Evaluating Serial Changes in Angiosome Foot Perfusion in Critical Limb Ischemia. Adv Wound Care (New Rochelle). 2020 Mar 1;9(3):103-110. doi: 10.1089/wound.2018.0924. Epub 2020 Jan 24.
Results Reference
result
PubMed Identifier
33126838
Citation
Chou TH, Tram NK, Eisert SN, Bobbey AJ, Atway SA, Go MR, Stacy MR. Dual assessment of abnormal microvascular foot perfusion and lower extremity calcium burden in a patient with critical limb ischemia using hybrid SPECT/CT imaging. Vasc Med. 2021 Apr;26(2):225-227. doi: 10.1177/1358863X20964563. Epub 2020 Oct 30. No abstract available.
Results Reference
result
PubMed Identifier
33221224
Citation
Chou TH, Alvelo JL, Janse S, Papademetris X, Sumpio BE, Mena-Hurtado C, Sinusas AJ, Stacy MR. Prognostic Value of Radiotracer-Based Perfusion Imaging in Critical Limb Ischemia Patients Undergoing Lower Extremity Revascularization. JACC Cardiovasc Imaging. 2021 Aug;14(8):1614-1624. doi: 10.1016/j.jcmg.2020.09.033. Epub 2020 Nov 18.
Results Reference
result
PubMed Identifier
35252240
Citation
Tram NK, Chou TH, Patel S, Ettefagh LN, Go MR, Atway SA, Stacy MR. Novel Application of 18F-NaF PET/CT Imaging for Evaluation of Active Bone Remodeling in Diabetic Patients With Charcot Neuropathy: A Proof-of-Concept Report. Front Med (Lausanne). 2022 Feb 18;9:795925. doi: 10.3389/fmed.2022.795925. eCollection 2022.
Results Reference
result

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Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease

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