Effect of Exercise on Indocyanine Green (ICG) Lymphography Imaging

Summary

Indocyanine Green (ICG) lymphography is a relatively new imaging technique that allows for quick visualization of superficial lymph flow in real-time, without radiation exposure. This imaging is useful for diagnosing and assessing lymphedema. ICG lymphography has a higher sensitivity and specificity than lymphoscintigraphy, the current gold standard imaging device for lymphedema. ICG lymphography precisely and reliably diagnoses, tracks, and stages lymphedema severity, ranging from subclinical or early lymphedema to more advanced cases. The ICG contrast dye used to visualize the lymphatic system takes approximately six hours to plateau. Therefore, patients must wait six hours between their initial and delayed scans. The purpose of this study is to determine if exercising on a Nu-step device between ICG initial and delayed scans would shorten the period of time a patient had to spend at the hospital on the day of their ICG lymphography. The general procedures for this involve (after selecting subjects, consenting subjects, educating the subject on the protocol, along with other appropriate measures): * Taking baseline vitals (HR \& SpO2) and limb circumference measurements * 5-minute period of time to acquaint subject with the exercise equipment (Nu-Step) at any level of exertion * injection of contrast agent to allow for visualization of the superficial lymphatic system by a qualified nurse * Initial scan * A 5-minute period of exercise at "moderate" level of exercise (This correlates to the rating of perceived exertion levels of 12-13; All exercise periods should be at this level and will be monitored by a provider) * Second scan \& vitals * 5-minute period of exercise * Third scan \& vitals o Continue 5-minute exercise period followed by scan \& vitals until disease pattern emerges \* Exercise for 5 minutes then scan and vitals until images reach steady state for two consecutive scans * Final vitals (HR \& SpO2) \* Repeat scan every 1 hour until the normal 6 hour scan to monitor for further changes in lymphatic pattern. * Exit survey

Timeline

Start

2019-04-15

Primary completion

2019-09-30

Completion

2019-12-31

Publications

• Background Dylke ES, Schembri GP, Bailey DL, Bailey E, Ward LC, Refshauge K, Beith J, Black D, Kilbreath SL. Diagnosis of upper limb lymphedema: development of an evidence-based approach. Acta Oncol. 2016 Dec;55(12):1477-1483. doi: 10.1080/0284186X.2016.1191668. Epub 2016 Jun 22.
• Background Lee BB, Laredo J. Contemporary role of lymphoscintigraphy: we can no longer afford to ignore! Phlebology. 2011 Aug;26(5):177-8. doi: 10.1258/phleb.2011.011e01. No abstract available.
• Background Mihara M, Hara H, Araki J, Kikuchi K, Narushima M, Yamamoto T, Iida T, Yoshimatsu H, Murai N, Mitsui K, Okitsu T, Koshima I. Indocyanine green (ICG) lymphography is superior to lymphoscintigraphy for diagnostic imaging of early lymphedema of the upper limbs. PLoS One. 2012;7(6):e38182. doi: 10.1371/journal.pone.0038182. Epub 2012 Jun 4.
• Background Chen WF, Zhao H, Yamamoto T, Hara H, Ding J. Indocyanine Green Lymphographic Evidence of Surgical Efficacy Following Microsurgical and Supermicrosurgical Lymphedema Reconstructions. J Reconstr Microsurg. 2016 Nov;32(9):688-698. doi: 10.1055/s-0036-1586254. Epub 2016 Aug 3.
• Background Yamamoto T, Matsuda N, Doi K, Oshima A, Yoshimatsu H, Todokoro T, Ogata F, Mihara M, Narushima M, Iida T, Koshima I. The earliest finding of indocyanine green lymphography in asymptomatic limbs of lower extremity lymphedema patients secondary to cancer treatment: the modified dermal backflow stage and concept of subclinical lymphedema. Plast Reconstr Surg. 2011 Oct;128(4):314e-321e. doi: 10.1097/PRS.0b013e3182268da8.
• Background Yamamoto T, Yoshimatsu H, Narushima M, Yamamoto N, Hayashi A, Koshima I. Indocyanine Green Lymphography Findings in Primary Leg Lymphedema. Eur J Vasc Endovasc Surg. 2015 Jan;49(1):95-102. doi: 10.1016/j.ejvs.2014.10.023.
• Background International Society of Lymphology. The diagnosis and treatment of peripheral lymphedema: 2013 Consensus Document of the International Society of Lymphology. Lymphology. 2013 Mar;46(1):1-11.
• Background Johnson JH, Phipps LK. Preferred method of selecting exercise intensity in adult women. J Strength Cond Res. 2006 May;20(2):446-9. doi: 10.1519/R-17935.1.
• Background Singh B, Disipio T, Peake J, Hayes SC. Systematic Review and Meta-Analysis of the Effects of Exercise for Those With Cancer-Related Lymphedema. Arch Phys Med Rehabil. 2016 Feb;97(2):302-315.e13. doi: 10.1016/j.apmr.2015.09.012. Epub 2015 Oct 9.
• Background Morris C, Wonders KY. Concise review on the safety of exercise on symptoms of lymphedema. World J Clin Oncol. 2015 Aug 10;6(4):43-4. doi: 10.5306/wjco.v6.i4.43.
• Background Desai P, Williams AG Jr, Prajapati P, Downey HF. Lymph flow in instrumented dogs varies with exercise intensity. Lymphat Res Biol. 2010 Sep;8(3):143-8. doi: 10.1089/lrb.2009.0029.
• Background Downey HF, Durgam P, Williams AG Jr, Rajmane A, King HH, Stoll ST. Lymph flow in the thoracic duct of conscious dogs during lymphatic pump treatment, exercise, and expansion of extracellular fluid volume. Lymphat Res Biol. 2008;6(1):3-13. doi: 10.1089/lrb.2007.1017.
• Background Cemal Y, Pusic A, Mehrara BJ. Preventative measures for lymphedema: separating fact from fiction. J Am Coll Surg. 2011 Oct;213(4):543-51. doi: 10.1016/j.jamcollsurg.2011.07.001. Epub 2011 Jul 28. No abstract available.
• Background Unno N, Nishiyama M, Suzuki M, Yamamoto N, Inuzuka K, Sagara D, Tanaka H, Konno H. Quantitative lymph imaging for assessment of lymph function using indocyanine green fluorescence lymphography. Eur J Vasc Endovasc Surg. 2008 Aug;36(2):230-236. doi: 10.1016/j.ejvs.2008.04.013. Epub 2008 Jun 4.
• Background Yamamoto T, Narushima M, Doi K, Oshima A, Ogata F, Mihara M, Koshima I, Mundinger GS. Characteristic indocyanine green lymphography findings in lower extremity lymphedema: the generation of a novel lymphedema severity staging system using dermal backflow patterns. Plast Reconstr Surg. 2011 May;127(5):1979-1986. doi: 10.1097/PRS.0b013e31820cf5df.
• Background Yamamoto T, Yamamoto N, Doi K, Oshima A, Yoshimatsu H, Todokoro T, Ogata F, Mihara M, Narushima M, Iida T, Koshima I. Indocyanine green-enhanced lymphography for upper extremity lymphedema: a novel severity staging system using dermal backflow patterns. Plast Reconstr Surg. 2011 Oct;128(4):941-947. doi: 10.1097/PRS.0b013e3182268cd9.
• Background Rockson SG, Rivera KK. Estimating the population burden of lymphedema. Ann N Y Acad Sci. 2008;1131:147-54. doi: 10.1196/annals.1413.014.
• Background Lasinski BB, McKillip Thrift K, Squire D, Austin MK, Smith KM, Wanchai A, Green JM, Stewart BR, Cormier JN, Armer JM. A systematic review of the evidence for complete decongestive therapy in the treatment of lymphedema from 2004 to 2011. PM R. 2012 Aug;4(8):580-601. doi: 10.1016/j.pmrj.2012.05.003.

Drugs

Indications