Peripheral Artery DiseaseNCT03622359
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
A study testing SPECT/CT perfusion imaging and PET/CT perfusion imaging in people with Peripheral Artery Disease and Diabetes Mellitus, run by Nationwide Children's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peripheral Artery Disease, Diabetes Mellitus, Chronic Limb-Threatening Ischemia
- What is being tested?
- SPECT/CT perfusion imaging and PET/CT perfusion imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2017to 31 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- No evidence or prior diagnosis of peripheral artery disease based on chart review and standard vascular screening.
Who cannot join
- Unable to give informed consent of follow-up
- Pregnant or nursing
- Under the age of 18
- History of peripheral artery disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Mitchel R Stacy, Ph.D., 614-355-5836, Mitchel.Stacy@nationwidechildrens.org
About this study
Official title: Radiotracer Imaging of Skeletal Muscle Perfusion in Patients With Peripheral Artery Disease
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.
Read the detailed description
PAD patients (n=80) with peripheral artery 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. An additional subset of PAD patients (n=56) and healthy control subjects (n=56) will be enrolled to undergo the same imaging procedures to establish a healthy database for PET perfusion imaging measures.
- Being tested
- SPECT/CT perfusion imaging, PET/CT perfusion imaging
- Keywords
- Radionuclide imaging, Perfusion imaging, Positron emission tomography, Single photon emission computed tomography
- Medical subject headings
- Peripheral Arterial Disease, Diabetes Mellitus, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPECT/CT perfusion imagingDiagnostic test
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 imagingDiagnostic test
Subjects will receive a standard clinical dose of a radionuclide for perfusion imaging of the lower extremities before and after revascularization procedures.
| Study group | Role | What they receive |
|---|---|---|
| SPECT/CT perfusion imaging | Experimental | 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. Receives: Diagnostic Test: SPECT/CT perfusion imaging; Diagnostic Test: PET/CT perfusion imaging |
| PET/CT perfusion imaging | Experimental | 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. Receives: Diagnostic Test: SPECT/CT perfusion imaging; Diagnostic Test: PET/CT perfusion imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower extremity perfusion
The percent or absolute change in perfusion from baseline to post-revascularization will be evaluated.
Measured: 1-2 weeks
Secondary outcomes (2)
Wound healing
Rates of wound healing will be documented for 12 months following enrollment into the imaging study.
Measured: 1 year
Limb salvage
Amputation rates will be documented for the 12 months following enrollment into the imaging study.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start17 Feb 2017
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University
- Responsible party
- Principal investigator, Mitchel Stacy, Nationwide Children's Hospital
- Investigators
- Mitchel R Stacy, Ph.D., Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622359
- Sponsor's protocol ID
- IRB18-00442
- Status last verified
- Oct 2026
- First submitted
- 2 Aug 2018
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31482412Stacy 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.
PubMed 35096884Alvelo 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.
PubMed 29748311Chou 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.
PubMed 31993252Chou 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.
PubMed 33126838Chou 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.
PubMed 33221224Tram 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.
PubMed 35252240Rimmerman ET, Musini KN, Chou TH, Wynveen MK, Patel SA, Beall M, Bobbey AJ, Atway SA, Go MR, Stacy MR. Vessel-by-Vessel Computed Tomography Calcium Scoring of the Foot in Peripheral Artery Disease: Association with Patient-Level Factors. Adv Wound Care (New Rochelle). 2023 Nov;12(11):603-610. doi: 10.1089/wound.2022.0151. Epub 2023 Feb 7.
PubMed 36601736Chou TH, Rimmerman ET, Patel S, Wynveen MK, Eisert SN, Musini KN, Janse SA, Bobbey AJ, Sarac TP, Atway SA, Go MR, Stacy MR. 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. EJNMMI Res. 2023 Jan 17;13(1):3. doi: 10.1186/s13550-023-00951-0.
PubMed 36648583Chou TH, Wynveen MK, Rimmerman ET, Patel S, Go MR, Stacy MR. Detection of multivessel calcific disease progression in a patient with chronic limb-threatening ischemia using fluorine-18 sodium fluoride positron emission tomography imaging. J Vasc Surg Cases Innov Tech. 2023 Mar 4;9(2):101137. doi: 10.1016/j.jvscit.2023.101137. eCollection 2023 Jun.
PubMed 37139350Chou TH, Nabavinia M, Tram NK, Rimmerman ET, Patel S, Musini KN, Eisert SN, Wolfe T, Wynveen MK, Matsuzaki Y, Kitsuka T, Iwaki R, Janse SA, Bobbey AJ, Breuer CK, Goodchild L, Malbrue R, Shinoka T, Atway SA, Go MR, Stacy MR. Quantification of Skeletal Muscle Perfusion in Peripheral Artery Disease Using 18F-Sodium Fluoride Positron Emission Tomography Imaging. J Am Heart Assoc. 2024 Feb 20;13(4):e031823. doi: 10.1161/JAHA.123.031823. Epub 2024 Feb 14.
PubMed 38353265