Effect of Exercise on Indocyanine Green (ICG) Lymphography Imaging

NCT03584633 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 201803867
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Lymphedema

Keywords

Indocyanine Green; Indocyanine Green Lymphography; Exercise

Outcome Measures

Primary Outcomes (1)

• Time for Initial Disease Pattern to Appear

  After subjects exercise, this outcome will be measured by indocyanine green lymphography scans, a non-radioactive scan that visualizes the lymphatic system

  ICG scan is performed every 5 minutes with the test subjects exercising until the initial disease pattern is seen. We expect initial disease pattern to appear within a minute following administration of ICG.

Secondary Outcomes (1)

• Time to Reach Indocyanine Green Lymphography Steady State

  ICG scan was performed every 5 minutes until lymphographic plateau was reached. The Lymphographic plateau is defined as having no observable changes in lymphographic patterns. We estimate all patients to reach plateau within 20 minutes.

Study Arms (1)

Lymphedema

OTHER

The subjects with lymphedema will be exercising on a Nu-Step exercise machine that will exercise their arms and legs simultaneously for five-minute intervals. Every five minutes their limbs will be imaged with Indocyanine Green Lymphography.

Drug: Indocyanine Green

Interventions

Indocyanine Green DRUG

The subjects will be exercising on a Nu-Step exercise machine that will exercise their arms and legs simultaneously for five-minute intervals. Every five minutes their limbs will be imaged with an ICG lymphography device to determine the plateau rate of indocyanine green dye after exercise.

Also known as: NOVADAQ SPY Elite System Indocyanine Green Lymphography

Lymphedema

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients
• Suspected lymphedema or previously diagnosed lymphedema
• Between the ages of 18-85 years old.

You may not qualify if:

• Allergies to iodine
• pregnant
• nursing
• On daily heart medication
• Have medical conditions affecting the heart, lungs or joint conditions that prevent prolonged physical activity of the arms or legs.

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (18)

• 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.

  PMID: 27333213 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.

  PMID: 21791706 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.

  PMID: 22675520 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.

  PMID: 27487485 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.

  PMID: 21921744 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.

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• 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.

  PMID: 23930436 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.

  PMID: 16686578 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.

  PMID: 26440777 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.

  PMID: 26266100 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.

  PMID: 20863266 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.

  PMID: 18361766 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.

  PMID: 21802319 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.

  PMID: 18534875 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.

  PMID: 21532424 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.

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MeSH Terms

Conditions

Lymphedema; Motor Activity

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Wei F. Chen
• Organization: Cleveland Clinic

chenw6@ccf.org

319-333-6166

Study Officials

• Wei F Chen, MD, FACS

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: July 12, 2018
• Study Start: April 15, 2019
• Primary Completion: September 30, 2019
• Study Completion: December 31, 2019
• Last Updated: December 27, 2024
• Results First Posted: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)