Recruiting

Nuclear Perfusion Imaging

Sponsor:

Nationwide Children's Hospital

Code:

NCT03622359

Conditions

Peripheral Artery Disease

Diabetes Mellitus

Chronic Limb-Threatening Ischemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

SPECT/CT perfusion imaging

PET/CT perfusion imaging

Study Details

Brief summary:

The aim of this clinical study is to 1) establish a healthy database for nuclear perfusion imaging of the lower extremities and 2) assess the prognostic value of radiotracer-based perfusion imaging for predicting clinical outcomes in patients with peripheral artery 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 quantifying regional abnormalities in skeletal muscle perfusion and evaluating responses to medical treatment.

Conditions

Peripheral Artery Disease

Diabetes Mellitus

Chronic Limb-Threatening Ischemia

Study ID

NCT03622359

Start date

Feb 17, 2017

Status verified date

Oct, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria for Patients with Peripheral Artery Disease:

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 for Patients with Peripheral Artery Disease:

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

Inclusion Criteria for Healthy Control Subjects:

1. At least 18 years of age
2. No evidence or prior diagnosis of peripheral artery disease based on chart review and standard vascular screening.

Exclusion Criteria for Healthy Control Subjects:

1. Unable to give informed consent of follow-up
2. Pregnant or nursing
3. Under the age of 18
4. History of peripheral artery disease

Study Design

Enrollment

192 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: SPECT/CT perfusion imaging

Patients with peripheral artery 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.

experimental: PET/CT perfusion imaging

Patients with peripheral artery 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.

Interventions

SPECT/CT perfusion imaging

Subjects will receive a standard clinical dose of a radionuclide for perfusion imaging of the lower extremities before and after revascularization procedures.

PET/CT perfusion imaging

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

  • Lower extremity perfusion [ Time Frame: 1-2 weeks ]

Central Contacts and Locations

Central contacts

Mitchel R Stacy, Ph.D.

614-355-5836Mitchel.Stacy@nationwidechildrens.org

Locations

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

Contacts

Mitchel R Stacy, Ph.D.

614-355-5836Mitchel.Stacy@nationwidechildrens.org

More Information

Sponsor

Nationwide Children's Hospital

Last update posted

Oct 23, 2026

Last verified

Oct, 2026

Keywords

  • Radionuclide imaging
  • Perfusion imaging
  • Positron emission tomography
  • Single photon emission computed tomography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Nationwide Children's Hospital on 2026-10-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.