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Lactate

PG. Single Voxel MR Spectroscopy in Non-Herniated Painful, Herniated Painful, and Non-Painful Lumbar Discs. Lactate. col. L Tanenbaum 1 , S·Hu 2 , M·Gornet 3 , S·Berven 2 , J·Peacock 4 , J·Lotz 2,4 , D·Bradford 4 ,·J Claude 4 , P·Kane 4 , F·Schranck 3 , D·Stewart 5

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Lactate

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  1. PG Single Voxel MR Spectroscopy in Non-Herniated Painful, Herniated Painful, and Non-Painful Lumbar Discs Lactate col L Tanenbaum1, S·Hu2, M·Gornet3, S·Berven2, J·Peacock4, J·Lotz2,4, D·Bradford4,·J Claude4, P·Kane4, F·Schranck3, D·Stewart5 1Icahn School of Medicine at Mount Sinai, 2University of California San Francisco, 3Orthopedic Center of Saint Louis, 4Nocimed, LLC, 5MRI Partners of Chesterfield 1

  2. Disclosures 2 Tanenbaum, L: Nocimed, LLC - advisory board Bradford, D; Lotz, J: Nocimed, LLC - management, shareholder, royalty Kane, P; Claude, J: Nocimed, LLC - shareholder, consulting Peacock, J: Nocimed, LLC - management, shareholder Schranck, F; Gornet, M: The Orthopedic Center of St. Louis - Nocimed sponsored research grant, Nocimed, LLC - shareholder

  3. Purpose 3 • Evaluate non-invasive in vivo single voxel MR spectroscopy (SVS) in lumbar discs on two commercial 3T scanners - GE Signa & Siemens Verio for • discogenic low back pain (LBP) pain patients receiving provocative discography (PD), and • asymptomatic control volunteers (ASY) • Correlate results to clinical phenotypes • non-herniated painful (NHP) • herniated painful (HP) • non-painful (NP) discs

  4. BackgroundDisc degeneration • altered disc structure and biochemical composition that may or may not cause pain • decreased proteoglycan synthesis • increase matrix catabolism • features that differentiate painful from non painful degenerative discs not well understood. *Buser, 2010 Spine: Affiliated Society Meeting Abstracts

  5. Nucleus samples BackgroundDisc degeneration • consistent changes in markers of hypoxia, innervation and inflammation showed strong correlation with discs associated with pain • Gene expression with highest correlation between painful vs. non-painful discs relate to (R2=.67): • hypoxia- lactate dehydrogenase; • innervation - nerve growth factor. *Buser, 2010 Spine: Affiliated Society Meeting Abstracts *Buser, 2010 Spine: Affiliated Society Meeting Abstracts

  6. Background Identifying the painful disc • Painful discs are distinguished by hypoxia, inflammation, neovascularization & neoinnervation* • Consistent changes in biomarkers/chemical mediators detectable and quantifiable with MR spectroscopy *Freemont, A. J., (2009) Rheumatology; 48:5–10.

  7. Lactate PG col PG Lactate col Background-Ex vivo Disc SVS, 11T HR MAS Surgical Samples – PG/LA Non-Painful Disc (Scoliosis) n=9 p<.005 Painful Disc (PD+, LBP) n=9 Keshari, Spine 2008. 33(3): p. 312-317 8

  8. Materials & Methods 9 • Iterative technical development protocol • Conducted in series: GE (2008-10), Siemens (2011-13) • T1/T2 weighted imaging sequences • SVS acquisition, each lumbar disc sequentially • Inter-platform differences: • OVS bands: GE only (not used for Siemens) • Autoshim  Auto + Manual shim: Siemens protocol refinement • Manual voxel localization in disc to remove end-plates

  9. Materials & Methods 10 • Acquisition Systems • GE SignaHDxt 3.0T, v14x • HDCTL 456 spine coil • Pulse Sequence: custom Chess/Press • “modified” PROSETM for disc SVS: TR=1500, TE=28ms • Siemens 3T Verio, Model 10276755  Numaris/4 • Spine Coil Model 8622743 • Pulse Sequence: SVS Syngo VB17 Version 1.0 • investigational “patch” for 3-5mm voxel height • Both single center, Nocimed sponsored, IRB approved • GE 3T: University of California at San Francisco • Siemens 3T: The Orthopedic Center of St. Louis

  10. Materials & Methodssignal post-processing Non-Painful Disc Non- Painful AutomatedChannel Select  Frame Edit  Phase/Freq  Apodize  Aggregate  Baseline 11

  11. Materials & Methodstechnical “success” & signal quality assessment • GE data: initial in vivo development cycle of entireapproach • Reported data not include technical failures for poor signal quality • Technical “failures” = only “indeterminate” results of Dx correlation algorithm • SIEMENS data: x-platform application/refinement of prior learning • Less technical development required • Reported data includes all completed acquisitions - signal quality successes &failures • Primary Signal (satisfactory) Quality Assessment Criteria: • SNR > 3 for PG or LA peak regions • Water FWHM < 35 Hz • Presence (fail) or Absence (accept) of lipid motion artifact 12

  12. Materials & Methodsdiagnostic interpretation/correlation to disc type • Different approach per platform, serial development phases • Earlier GE platform data: • Multi-variate (PG & LA) automated statistical algorithm development via “JMP” logistic regression software • Predictive value of SVS biomarker measures for painful vs. non-painful • Later Siemens platform data: • Simple PG/LA ratio • Predictive value/statistical modeling planned (> more pain patients) 1% 1% 99% 13

  13. Materials & Methodsstudy design – inclusion criteria 14 • Male and non-pregnant females, 18-70 yrs old • Pain group: • Oswestry Disability Index ≥ 40%, or Visual Analog Scale ≥ 4 • Indicated for Lumbar Spine Provocation Discography (PD) • Practice Guidelines for Spinal Diagnostic and Treatment Procedures (ISIS, 2004) • PD performed 6wk-6mo before, or 1mo after, Disc SVS exam • Up to 12 mo before in earlier GE study • Asymptomatic control volunteers: • Absent chronic severe LBP • VAS≤1, ODI≤10.

  14. Materials & Methodsstudy design – exclusion criteria 15 • Complicating extradiscal pain sources • fracture, spondylolisthesis, spondylolysis • Prior lumbar surgery or intradiscal treatments • except diagnostic provocative or anesthetic discography • Chronic disease or pain, or psychological dysfunction, relevant to study objectives

  15. GE studyn= 42 Subjects, 79 Discs1 Volunteers n=28 Painful Discs (PD+) Non-Painful Discs (PD-) Non-PainfulDiscs (assumed) n = 15 • n = 49 n = 15 + Control, Painful n = 64 - Control, Non-Painful 16 Pain Pts (PD) n=14

  16. Siemens studyn=33 Subjects, 130 Discs1 Volunteers n=19 Non-Herniated Painful Discs (PD+) Non-Painful Discs (assumed) Herniated Painful Discs (PD+) Non-Painful Discs (PD-& remotelevels) • n = 1031 n = 16 n = 32 n = 9 n = 1191 1 Includes n=1 disc excluded from analysis as non-lumbar (S1-S2) 2 Includes n=1 disc analyzed separately due to “extra”discal co-morbidities (spondylosis + facet arthropathy) 17 Pain Pts (PD) n=14

  17. Results- 3T GE Signa Case 1, Pain Pt (PD+ L5S1, PD- L4L5) Discogram: +/- - + 18 Hu, Orthopaedic Research Society 2010

  18. Results - GE 3T Signa 94% (74/79) Determinate, 99% (73/74) Accurate (PG,LA) SVS Positive n=13 all true+* PG & LA-related Dx Algorithm “score” SVS Indeterminate n=5 SVS Negative n=60 true-, 1 false-* 19 Hu, Orthopaedic Research Society 2010

  19. Case 2 – 3T Siemens Verio NHP Pain Pt, 2-level PD+/- L1-L2 4mm Discogram: +/- L2-L3 5mm L3-L4 5mm L4-L5 6mm 0 L5-S1 6mm 10 22

  20. Results - Siemens 3T VerioSignal Quality Success  85% (100% Manual Shim, >1mm) 23

  21. Results - Siemens 3T VerioAutoshim only vs. Auto+Manual Shim – Example Asymptomatic Control Volunteer Auto+Manual shim Autoshim Only (Fail Water FWHM) L1L2 4mm L2L3 4mm N313 24

  22. Conclusionsdisc SVS signal quality - reliability 25 • 100%robust disc spectra per signal quality criteria @ ≥3mm disc height per later protocol refinements (autoshim + manual shim) of the Siemens 3T platform study • 80%reliability w/ autoshim only

  23. Results – Siemens 3T VerioPG/LA Dx Correlation vs. Disc “Type” Controls (n=110) n=8 n=100 26

  24. Combined Siemens & GE 3T ResultsPG & LA correlate 174/175 (>99%) discs, 72 subjects 27

  25. Conclusions 28 • Combined PG & LA-related results from the two serial GE & Siemens 3T platform disc SVS development studies reflects >99%correlation between classic “contained” discogenic pain and non-painful discs in 175 total discs in 72 subjects • 100% PPV for pain in 13 painful PD+ discs • 0% False+ in 161 non-painful discs

  26. Conclusions 29 • Disc SVS may be most appropriate for classic contained axial discogenic low back pain w/o extradiscal pain generators, vs. pain caused by extradiscal morbidities (e.g. herniations, facet, vertebral abnormalities) • may still enhance Dx regimen in multi-factorial cases involving both intra-discal and extra-discal pain sources

  27. PG Single Voxel MR Spectroscopy in Non-Herniated Painful, Herniated Painful, and Non-Painful Lumbar Discs Lactate col L Tanenbaum1, S·Hu2, M·Gornet3, S·Berven2, J·Peacock4, J·Lotz2,4, D·Bradford4,·J Claude4, P·Kane4, F·Schranck3, D·Stewart5 1Icahn School of Medicine at Mount Sinai, 2University of California San Francisco, 3Orthopedic Center of Saint Louis, 4Nocimed, LLC, 5MRI Partners of Chesterfield 30

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