FootPCCT
Assessing Patients With Suspected Stress or Insufficiency Fracture of the Lower Extremity With Photon-Counting-Computed-Tomography
Sponsor study identifier
observational
50
1 country
1
Study Start
September 1, 2023
Actual (reported)Primary Completion
December 31, 2023
Actual (reported)Study Completion
January 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Stress fractures (fatigue or insufficiency fracture) are caused by the mismatch between bone strength and chronic stress applied to the bone. The vast majority of these fractures occur in the lower extremity. Early-stage diagnosis is crucial to optimize patient care. Appropriate imaging is relevant in confirming diagnosis after clinical suspicion of stress fractures. Radiographs have low sensitivity, so a relevant number of fractures go undetected. MRI has a high sensitivity, but its availability is limited, and its respective examination time is prolonged. This study investigates the diagnostic accuracy of PCCT in lower extremity stress fractures as a dose-saving technology, guaranteeing an examination according to the ALARA-principle (as low as reasonably achievable).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 21, 2023
Actual (reported)September 1, 2023
Actual (reported)September 6, 2023
Actual (reported)December 31, 2023
Actual (reported)January 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Presence of a fracture
Presence/absence of a fracture
Day 1, 4weeks follow up assessment
Presence of bone edema
Day 1, 4weeks follow up assessment
Presence of soft tissue edema
Day1, 4weeks follow up assessment
Initial and follow up (after 4 weeks) PCCT acquisition of the affected area of the lower extremity. Image acquisition will be performed on the PCCT
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
In cooperation with the Foot Clinic at the Balgrist University Hospital Zurich, potential study candidates with suspected stress fracture who will undergo an MRI to confirm the diagnosis are prospectively screened and proposed to join the study.
Balgrist University Hospital
Zurich, Canton of Zurich, 8008, Switzerland
Palmer W, Bancroft L, Bonar F, Choi JA, Cotten A, Griffith JF, Robinson P, Pfirrmann CWA. Glossary of terms for musculoskeletal radiology. Skeletal Radiol. 2020 Jul;49(Suppl 1):1-33. doi: 10.1007/s00256-020-03465-1. Epub 2020 Jun 2.
Lassus J, Tulikoura I, Konttinen YT, Salo J, Santavirta S. Bone stress injuries of the lower extremity: a review. Acta Orthop Scand. 2002 Jun;73(3):359-68. doi: 10.1080/000164702320155392.
Stephan Wirth, PD Dr.med.
Balgrist University Hospital
First Submitted
August 21, 2023
First Posted
September 6, 2023
Study Start
September 1, 2023
Actual (reported)Primary Completion
December 31, 2023
Actual (reported)Pain localization
Day 1, 4 weeks follow up assessment, 12 weeks follow up assessment
Pain character
Day 1, 4 weeks follow up assessment, 12 weeks follow up assessment
Pain intensity
Day 1, 4 weeks follow up assessment, 12 weeks follow up assessment
Contact the study team to confirm eligibility.
Wright AA, Hegedus EJ, Lenchik L, Kuhn KJ, Santiago L, Smoliga JM. Diagnostic Accuracy of Various Imaging Modalities for Suspected Lower Extremity Stress Fractures: A Systematic Review With Evidence-Based Recommendations for Clinical Practice. Am J Sports Med. 2016 Jan;44(1):255-63. doi: 10.1177/0363546515574066. Epub 2015 Mar 24.
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Cabarrus MC, Ambekar A, Lu Y, Link TM. MRI and CT of insufficiency fractures of the pelvis and the proximal femur. AJR Am J Roentgenol. 2008 Oct;191(4):995-1001. doi: 10.2214/AJR.07.3714.
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Bongartz T, Glazebrook KN, Kavros SJ, Murthy NS, Merry SP, Franz WB 3rd, Michet CJ, Veetil BM, Davis JM 3rd, Mason TG 2nd, Warrington KJ, Ytterberg SR, Matteson EL, Crowson CS, Leng S, McCollough CH. Dual-energy CT for the diagnosis of gout: an accuracy and diagnostic yield study. Ann Rheum Dis. 2015 Jun;74(6):1072-7. doi: 10.1136/annrheumdis-2013-205095. Epub 2014 Mar 25.
Hidas G, Eliahou R, Duvdevani M, Coulon P, Lemaitre L, Gofrit ON, Pode D, Sosna J. Determination of renal stone composition with dual-energy CT: in vivo analysis and comparison with x-ray diffraction. Radiology. 2010 Nov;257(2):394-401. doi: 10.1148/radiol.10100249. Epub 2010 Aug 31.
Esquivel A, Ferrero A, Mileto A, Baffour F, Horst K, Rajiah PS, Inoue A, Leng S, McCollough C, Fletcher JG. Photon-Counting Detector CT: Key Points Radiologists Should Know. Korean J Radiol. 2022 Sep;23(9):854-865. doi: 10.3348/kjr.2022.0377.
Marcus RP, Fletcher JG, Ferrero A, Leng S, Halaweish AF, Gutjahr R, Vrtiska TJ, Wells ML, Enders FT, McCollough CH. Detection and Characterization of Renal Stones by Using Photon-Counting-based CT. Radiology. 2018 Nov;289(2):436-442. doi: 10.1148/radiol.2018180126. Epub 2018 Aug 7.
Tenforde AS, Fredericson M. Influence of sports participation on bone health in the young athlete: a review of the literature. PM R. 2011 Sep;3(9):861-7. doi: 10.1016/j.pmrj.2011.05.019.
Grunz JP, Heidenreich JF, Lennartz S, Weighardt JP, Bley TA, Ergun S, Petritsch B, Huflage H. Spectral Shaping Via Tin Prefiltration in Ultra-High-Resolution Photon-Counting and Energy-Integrating Detector CT of the Temporal Bone. Invest Radiol. 2022 Dec 1;57(12):819-825. doi: 10.1097/RLI.0000000000000901. Epub 2022 Jun 24.
Grunz JP, Petritsch B, Luetkens KS, Kunz AS, Lennartz S, Ergun S, Bley TA, Huflage H. Ultra-Low-Dose Photon-Counting CT Imaging of the Paranasal Sinus With Tin Prefiltration: How Low Can We Go? Invest Radiol. 2022 Nov 1;57(11):728-733. doi: 10.1097/RLI.0000000000000887. Epub 2022 May 6.
Study Completion
January 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 28, 2024
Record last verified: 2024-03
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Source: ClinicalTrials.gov.
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