Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID03622359

Radiotracer Imaging of Skeletal Muscle Perfusion in Patients With Peripheral Artery Disease

Led by Nationwide Children's Hospital · Updated on 2025-04-01

192

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

Sponsors

N

Nationwide Children's Hospital

Lead Sponsor

O

Ohio State University

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to create a healthy database for nuclear perfusion imaging of the lower legs and to evaluate how well radiotracer-based imaging predicts clinical outcomes in patients with peripheral artery disease (PAD) undergoing lower leg revascularization. The study tests whether this imaging method can sensitively detect regional blood flow problems in leg muscles and monitor responses to treatment. Patients with PAD scheduled for revascularization will receive two types of imaging: SPECT/CT or PET/CT perfusion scans. Each patient will get an intravenous injection of a radiotracer before and 1 to 14 days after their procedure. A low-dose CT scan will follow each imaging session for better image analysis. Additionally, a group of PAD patients and healthy volunteers will undergo the same imaging to help build a healthy reference database. Participants will complete medical and physical activity questionnaires, standard PAD screenings including Ankle-Brachial and Toe-Brachial Indices, and imaging sessions before and shortly after their revascularization. Researchers will monitor clinical outcomes such as wound healing and limb salvage for up to 12 months. The main measure is blood flow in the lower legs within 1 to 2 weeks after treatment, with ongoing safety and outcome tracking throughout the study period.

CONDITIONS

Brief Title

Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years of age
  • Evidence of significant blockage in one or more lower leg arteries confirmed by prior tests such as ABI, TBI, CT angiography, ultrasound, or MRI
  • Able to give informed consent and participate in follow-up
  • For healthy controls: at least 18 years old with no history or signs of peripheral artery disease
Not Eligible

You will not qualify if you...

  • Unable to give informed consent or participate in follow-up
  • Pregnant or nursing
  • Under the age of 18
  • No history of peripheral artery disease (for patient group)
  • History of peripheral artery disease (for healthy control group)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for medical history and physical activity questionnaires and standard PAD screening including Ankle-Brachial and Toe-Brachial Indices

Diagnostic Evaluation

Duration - 1 to 2 weeks

Participants undergo SPECT/CT or PET/CT perfusion imaging before and after their scheduled lower extremity revascularization procedure.

2 imaging visits (in-person): one prior to revascularization and one 1 to 14 days post-procedure

Long-term Monitoring

Duration - Up to 12 months

Participants are followed for clinical outcomes including wound healing and limb salvage for up to 12 months after imaging.

Follow-up assessments occur periodically over 12 months to evaluate clinical outcomes

Trial Site Locations

Total: 1 location

1

Nationwide Children's Hospital

Columbus, Ohio, United States, 43205

Actively Recruiting

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Research Team

M

Mitchel R Stacy, Ph.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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Published Research Related To This Trial

Radiotracer Imaging Allows for Noninvasive Detection and Quantification of Abnormalities in Angiosome Foot Perfusion in Diabetic Patients With Critical Limb Ischemia and Nonhealing Wounds.

Jessica L Alvelo, Xenophon Papademetris, Carlos Mena-Hurtado...

https://pubmed.ncbi.nlm.nih.gov/29748311

SPECT/CT Imaging: A Noninvasive Approach for Evaluating Serial Changes in Angiosome Foot Perfusion in Critical Limb Ischemia.

Ting-Heng Chou, Said A Atway, Adam J Bobbey...

https://pubmed.ncbi.nlm.nih.gov/31993252

Dual assessment of abnormal microvascular foot perfusion and lower extremity calcium burden in a patient with critical limb ischemia using hybrid SPECT/CT imaging.

Ting-Heng Chou, Nguyen K Tram, Susan Natalie Eisert...

https://pubmed.ncbi.nlm.nih.gov/33126838

Prognostic Value of Radiotracer-Based Perfusion Imaging in Critical Limb Ischemia Patients Undergoing Lower Extremity Revascularization.

Ting-Heng Chou, Jessica L Alvelo, Sarah Janse...

https://pubmed.ncbi.nlm.nih.gov/33221224

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.

Nguyen K Tram, Ting-Heng Chou, Surina Patel...

https://pubmed.ncbi.nlm.nih.gov/35252240

Vessel-by-Vessel Computed Tomography Calcium Scoring of the Foot in Peripheral Artery Disease: Association with Patient-Level Factors.

Eleanor T Rimmerman, Kumudha Narayana Musini, Ting-Heng Chou...

https://pubmed.ncbi.nlm.nih.gov/36601736

Vessel-by-vessel analysis of lower extremity 18F-NaF PET/CT imaging quantifies diabetes- and chronic kidney disease-induced active microcalcification in patients with peripheral arterial disease.

Ting-Heng Chou, Eleanor T Rimmerman, Surina Patel...

https://pubmed.ncbi.nlm.nih.gov/36648583

Detection of multivessel calcific disease progression in a patient with chronic limb-threatening ischemia using fluorine-18 sodium fluoride positron emission tomography imaging.

Ting-Heng Chou, Molly K Wynveen, Eleanor T Rimmerman...

https://pubmed.ncbi.nlm.nih.gov/37139350