NCT03622359

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
33mo left

Started Feb 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Feb 2017Dec 2028

Study Start

First participant enrolled

February 17, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
10.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2028

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

11.5 years

First QC Date

August 2, 2018

Last Update Submit

March 27, 2025

Conditions

Peripheral Artery DiseaseDiabetes MellitusChronic Limb-Threatening Ischemia

Keywords

Radionuclide imagingPerfusion imagingPositron emission tomographySingle photon emission computed tomography

Outcome Measures

Primary Outcomes (1)

  • Lower extremity perfusion

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

    1-2 weeks

Secondary Outcomes (2)

  • Wound healing

    1 year

  • Limb salvage

    1 year

Study Arms (2)

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.

Diagnostic Test: SPECT/CT perfusion imagingDiagnostic 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.

Diagnostic Test: SPECT/CT perfusion imagingDiagnostic Test: PET/CT perfusion imaging

Interventions

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 imagingSPECT/CT perfusion imaging
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.

PET/CT perfusion imagingSPECT/CT perfusion imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Unable to give informed consent or follow-up
  • Pregnant or nursing
  • Under the age of 18
  • No history of peripheral artery disease
  • At least 18 years of age
  • No evidence or prior diagnosis of peripheral artery disease based on chart review and standard vascular screening.
  • Unable to give informed consent of follow-up
  • Pregnant or nursing
  • Under the age of 18
  • History of peripheral artery disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

RECRUITING

Related Publications (11)

  • 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.

    PMID: 29748311BACKGROUND

  • 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.

    PMID: 31993252BACKGROUND

  • 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.

    PMID: 31482412BACKGROUND

  • 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.

    PMID: 33126838BACKGROUND

  • 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.

    PMID: 33221224BACKGROUND

  • 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.

    PMID: 35252240BACKGROUND

  • 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.

    PMID: 35096884BACKGROUND

  • Rimmerman 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.

    PMID: 36601736BACKGROUND

  • Chou 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.

    PMID: 36648583BACKGROUND

  • Chou 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.

    PMID: 37139350BACKGROUND

  • Chou 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.

    PMID: 38353265BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial DiseaseDiabetes MellitusChronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemia

Study Officials

  • Mitchel R Stacy, Ph.D.

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mitchel R Stacy, Ph.D.

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator / Assistant Professor

Study Record Dates

First Submitted

August 2, 2018

First Posted

August 9, 2018

Study Start

February 17, 2017

Primary Completion (Estimated)

August 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

April 1, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)