Clinical trial NCT01573390: Non Invasive and Non-Contact Imaging Of Tissue Oxygenation and Vascular Reactivity
Official title: Non Invasive and Non-Contact Dual-modal Imaging Of Tissue Oxygenation and Vascular Reactivity Dynamic Imaging Of Tissue Metabolism and Vascular Function.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Quantitative Validation of Imaging System
Keywords: Non-invasive
tissue-oxygenation
hyperspectral
CWC imaging system
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2012-04-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Interested healthy volunteers

Brief summary: 1. Quantitative validation of non-contact oxygenation imaging by the CWC imaging system
2. Quantitative validation of non-contact vascular function imaging by the CWC imaging system
3. Evaluation of the clinical usability of the CWC imaging system for further technology development and engineering improvement

Detailed description: The hyperspectral imaging technique estimates cutaneous tissue oxygenation by illuminating tissue and detecting tissue reflectance at different wavelengths. One major advantage of hyperspectral imaging is non-invasive and non-contact detection of tissue functional properties. The dual-mode imaging system integrates hyperspectral and thermal imaging modalities for simultaneous assessment of cutaneous tissue oxygenation and vascular function. This clinical protocol is defined to validate the CWC system on healthy human subjects

Eligibility criteria: Inclusion Criteria:

* Adult 18 years and older
* No history of diabetes.
* No history of vascular disease

Exclusion Criteria:

* Under 18 years of age
* Unable to provide informed consent
* Prisoners
* Current smoker

Primary outcomes:
measure: Non-Contact Oxygenation Imagiing
timeFrame: 1 year
measure: Non-Contact Vascular Function Imaging
timeFrame: 1 year
Secondary outcomes:
measure: Clinical usability for Comprehensive Wound Centers
timeFrame: 1 year
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University.
state: Ohio
Study officials:
affiliation: Ohio State University
name: Chandan K Sen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xu RX, Huang K, Qin R, Huang J, Xu JS, Ding L, Gnyawali US, Gordillo GM, Gnyawali SC, Sen CK. Dual-mode imaging of cutaneous tissue oxygenation and vascular function. J Vis Exp. 2010 Dec 8;(46):2095. doi: 10.3791/2095.
citation: Singer AJ, Clark RA. Cutaneous wound healing. N Engl J Med. 1999 Sep 2;341(10):738-46. doi: 10.1056/NEJM199909023411006. No abstract available.
citation: Reiber GE. Diabetic foot care. Financial implications and practice guidelines. Diabetes Care. 1992 Mar;15 Suppl 1:29-31. doi: 10.2337/diacare.15.1.s29.
citation: Broughton G 2nd, Janis JE, Attinger CE. Wound healing: an overview. Plast Reconstr Surg. 2006 Jun;117(7 Suppl):1e-S-32e-S. doi: 10.1097/01.prs.0000222562.60260.f9.
citation: Sen CK. Wound healing essentials: let there be oxygen. Wound Repair Regen. 2009 Jan-Feb;17(1):1-18. doi: 10.1111/j.1524-475X.2008.00436.x.
citation: Leach RM, Treacher DF. Oxygen transport-2. Tissue hypoxia. BMJ. 1998 Nov 14;317(7169):1370-3. doi: 10.1136/bmj.317.7169.1370. No abstract available.
citation: Treacher DF, Leach RM. Oxygen transport-1. Basic principles. BMJ. 1998 Nov 7;317(7168):1302-6. doi: 10.1136/bmj.317.7168.1302. No abstract available.
citation: Chang N, Goodson WH 3rd, Gottrup F, Hunt TK. Direct measurement of wound and tissue oxygen tension in postoperative patients. Ann Surg. 1983 Apr;197(4):470-8. doi: 10.1097/00000658-198304000-00017.
citation: Wilson DF. Oxygen dependent quenching of phosphorescence: a perspective. Adv Exp Med Biol. 1992;317:195-201. doi: 10.1007/978-1-4615-3428-0_20.
citation: Griffiths JR, Robinson SP. The OxyLite: a fibre-optic oxygen sensor. Br J Radiol. 1999 Jul;72(859):627-30. doi: 10.1259/bjr.72.859.10624317. No abstract available.
citation: Scheffler A, Rieger H. Clinical information content of transcutaneous oxymetry (tcpO2) in peripheral arterial occlusive disease (a review of the methodological and clinical literature with a special reference to critical limb ischaemia). Vasa. 1992;21(2):111-26.
citation: Barker SJ, Tremper KK. Pulse oximetry: applications and limitations. Int Anesthesiol Clin. 1987 Fall;25(3):155-75. doi: 10.1097/00004311-198702530-00010.
citation: Shah SA, Bachrach N, Spear SJ, Letbetter DS, Stone RA, Dhir R, Prichard JW, Brown HG, LaFramboise WA. Cutaneous wound analysis using hyperspectral imaging. Biotechniques. 2003 Feb;34(2):408-13. doi: 10.2144/03342pf01.
citation: Zweier JL, Thompson-Gorman S, Kuppusamy P. Measurement of oxygen concentrations in the intact beating heart using electron paramagnetic resonance spectroscopy: a technique for measuring oxygen concentrations in situ. J Bioenerg Biomembr. 1991 Dec;23(6):855-71. doi: 10.1007/BF00786005.
citation: Ogawa S, Lee TM, Kay AR, Tank DW. Brain magnetic resonance imaging with contrast dependent on blood oxygenation. Proc Natl Acad Sci U S A. 1990 Dec;87(24):9868-72. doi: 10.1073/pnas.87.24.9868.
citation: Valk PE, Mathis CA, Prados MD, Gilbert JC, Budinger TF. Hypoxia in human gliomas: demonstration by PET with fluorine-18-fluoromisonidazole. J Nucl Med. 1992 Dec;33(12):2133-7.
citation: Hosokawa R, Nohara R, Fujibayashi Y, Okuda K, Ogino M, Hirai T, Fujita M, Tamaki N, Konishi J, Sasayama S. Myocardial metabolism of 123I-BMIPP in a canine model with ischemia: implications of perfusion-metabolism mismatch on SPECT images in patients with ischemic heart disease. J Nucl Med. 1999 Mar;40(3):471-8.
citation: Djordjevich L, Sadove MS. Basic principles of electrohaemodynamics. J Biomed Eng. 1981 Jan;3(1):25-33. doi: 10.1016/0141-5425(81)90101-1.
citation: Kongstad L, Grande PO. The role of arterial and venous pressure for volume regulation of an organ enclosed in a rigid compartment with application to the injured brain. Acta Anaesthesiol Scand. 1999 May;43(5):501-8. doi: 10.1034/j.1399-6576.1999.430503.x.
citation: Whiston R. Wound care. Principles of Doppler. Nurs Times. 1996 May 15-21;92(20):66-70. No abstract available.
citation: Luypaert R, Boujraf S, Sourbron S, Osteaux M. Diffusion and perfusion MRI: basic physics. Eur J Radiol. 2001 Apr;38(1):19-27. doi: 10.1016/s0720-048x(01)00286-8.
citation: Khan F, Newton DJ. Laser Doppler imaging in the investigation of lower limb wounds. Int J Low Extrem Wounds. 2003 Jun;2(2):74-86. doi: 10.1177/1534734603256271.
citation: Hlavova A, Linhart J, Provsky I, Ganz V, Fronek A. Measurement of blood flow in the femoral artery in man at rest and during exercise by local thermodilution. Scand J Clin Lab Invest Suppl. 1967;99:86-9. No abstract available.
citation: Johnson LL, Seldin DW. Clinical experience with technetium-99m teboroxime, a neutral, lipophilic myocardial perfusion imaging agent. Am J Cardiol. 1990 Oct 16;66(13):63E-67E. doi: 10.1016/0002-9149(90)90614-7.
citation: Kupriyanov VV, Nighswander-Rempel S, Xiang B. Mapping regional oxygenation and flow in pig hearts in vivo using near-infrared spectroscopic imaging. J Mol Cell Cardiol. 2004 Nov;37(5):947-57. doi: 10.1016/j.yjmcc.2004.07.007.
citation: Greenman RL, Panasyuk S, Wang X, Lyons TE, Dinh T, Longoria L, Giurini JM, Freeman J, Khaodhiar L, Veves A. Early changes in the skin microcirculation and muscle metabolism of the diabetic foot. Lancet. 2005 Nov 12;366(9498):1711-7. doi: 10.1016/S0140-6736(05)67696-9.
citation: Myers DE, Anderson LD, Seifert RP, Ortner JP, Cooper CE, Beilman GJ, Mowlem JD. Noninvasive method for measuring local hemoglobin oxygen saturation in tissue using wide gap second derivative near-infrared spectroscopy. J Biomed Opt. 2005 May-Jun;10(3):034017. doi: 10.1117/1.1925250.
citation: Khaodhiar L, Dinh T, Schomacker KT, Panasyuk SV, Freeman JE, Lew R, Vo T, Panasyuk AA, Lima C, Giurini JM, Lyons TE, Veves A. The use of medical hyperspectral technology to evaluate microcirculatory changes in diabetic foot ulcers and to predict clinical outcomes. Diabetes Care. 2007 Apr;30(4):903-10. doi: 10.2337/dc06-2209. Epub 2007 Feb 15.
citation: Khoobehi B, Beach JM, Kawano H. Hyperspectral imaging for measurement of oxygen saturation in the optic nerve head. Invest Ophthalmol Vis Sci. 2004 May;45(5):1464-72. doi: 10.1167/iovs.03-1069.
citation: Jarm T, Kragelj R, Liebert A, Lukasiewitz P, Erjavec T, Preseren-Strukelj M, Maniewski R, Poredos P, Miklavcic D. Postocclusive reactive hyperemia in healthy volunteers and patients with peripheral vascular disease measured by three noninvasive methods. Adv Exp Med Biol. 2003;530:661-9. doi: 10.1007/978-1-4615-0075-9_66.
citation: Hueber DM, Franceschini MA, Ma HY, Zhang Q, Ballesteros JR, Fantini S, Wallace D, Ntziachristos V, Chance B. Non-invasive and quantitative near-infrared haemoglobin spectrometry in the piglet brain during hypoxic stress, using a frequency-domain multidistance instrument. Phys Med Biol. 2001 Jan;46(1):41-62. doi: 10.1088/0031-9155/46/1/304.
citation: Franceschini MA, Moesta KT, Fantini S, Gaida G, Gratton E, Jess H, Mantulin WW, Seeber M, Schlag PM, Kaschke M. Frequency-domain techniques enhance optical mammography: initial clinical results. Proc Natl Acad Sci U S A. 1997 Jun 10;94(12):6468-73. doi: 10.1073/pnas.94.12.6468.