LymphedemaPhase 4NCT03584633
Effect of Exercise on Indocyanine Green (ICG) Lymphography Imaging
A Phase 4 study testing Indocyanine Green in people with Lymphedema, run by University of Iowa at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Lymphedema
- What is being tested?
- Indocyanine Green
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2019to 31 Dec 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients
- Suspected lymphedema or previously diagnosed lymphedema
- Between the ages of 18-85 years old.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Standardization of Indocyanine Green Lymphography Protocol With Exercise for Lymphedema Assessment
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.
Read more
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
- 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
Read the detailed description
Following consent, the patients will answer the questions in the screening questionnaire and this data will be collected. Patients that do not screen out of the study (i.e. meet all inclusion criteria and none of the exclusion criteria) will continue with the study. Individuals who meet the exclusion criteria will not continue.
Study participants will be asked to go to the Rehabilitation Therapies clinic on the lower level of the main hospital for a one time visit. The visit will take approximately three to six hours.
During the visit, height and weight will be measured. Circumference measurements of the arms and legs will also be measured with a measuring tape. Bioimpedance analysis of the limb will be performed to assess the fluid content in the limbs.
Pain Ease numbing spray will have been applied to three injection sites on the affected arm or leg. 0.1ml of 0.25% Indocyanine green (ICG) dye will then be injected into the distal arm or leg at three separate sites: two interdigital injections and one injection in the volar wrist or posterior to the medial malleolus.
An immediate scan will be acquired using an ICG lymphography device. The scan will take approximately five minutes to complete. The data from this image will be considered baseline. This image is part of the patient's normal care at our institution and would be done even if the subject was not in this study.
The participant will then use the Nu-Step exercise machine for five minutes at a rate of perceived exertion (RPE) of 12-13. Heart rate will be monitored during the exercise with a pulse oximeter. After five minutes, a delayed scan will be performed with the NOVADAQ SPY Elite System and data will be recorded. The participant will continue to exercise for five minutes at an RPE of 12-13 and be scanned after every five minutes until the scans show no change in lymph pattern after two consecutive scans. The patient will be undergoing scanning and be exercising for a maximum of one hour.
Limb circumference measurements and bioimpedance scans will be repeated after exercise has been completed. The scan will be repeated every 1 hour until the normal 6-hour scan to monitor for further changes in the lymphatic pattern.
A post-intervention questionnaire will then be provided to the participant to complete discussing their exercise experience that day during the study, their previous ICG experiences, and their preference between this protocol and the current scanning process.
During the study, the subject will be told when he/she is being photographed/recorded. The injections and scans are clinically-indicated and would occur whether the individual was in the study or not. The initial and last scans are clinically indicated to determine disease status. 3) clarify how the follow-up survey is completed via email
- Conditions
- Lymphedema
- Being tested
- Indocyanine Green
- Keywords
- Indocyanine Green, Indocyanine Green Lymphography, Exercise
- Medical subject headings
- Lymphedema, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine GreenDrug
Also called NOVADAQ SPY Elite System Indocyanine Green Lymphography
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Indocyanine Green |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
After subjects exercise, this outcome will be measured by indocyanine green lymphography, a non-radioactive scan that visualizes the lymphatic system.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start15 Apr 2019
- Primary completion30 Sep 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei F Chen, MD, FACS, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584633
- Sponsor's protocol ID
- 201803867
- Status last verified
- Dec 2024
- First submitted
- 5 Jun 2018
- Last updated
- 27 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27333213Lee 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.
PubMed 21791706Mihara 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.
PubMed 22675520Chen 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.
PubMed 27487485Yamamoto 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.
PubMed 21921744Yamamoto 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.
PubMed 25488514International 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.
PubMed 23930436Johnson 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.
PubMed 16686578Singh 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.
PubMed 26440777Morris 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.
PubMed 26266100Desai 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.
PubMed 20863266Downey 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.
PubMed 18361766Cemal 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.
PubMed 21802319Unno 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.
PubMed 18534875Yamamoto 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.
PubMed 21532424
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standardization of Indocyanine Green Lymphography Protocol With Exercise for Lymphedema Assessment
- ClinicalTrials.gov ID
- NCT03584633
- Acronym / sponsor ID
- 201803867
- Conditions
- Lymphedema
- Keywords
- Indocyanine Green, Indocyanine Green Lymphography, Exercise
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 12 Jul 2018 (actual)
- Results
- Posted 27 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
Detailed description
Following consent, the patients will answer the questions in the screening questionnaire and this data will be collected. Patients that do not screen out of the study (i.e. meet all inclusion criteria and none of the exclusion criteria) will continue with the study. Individuals who meet the exclusion criteria will not continue.
Study participants will be asked to go to the Rehabilitation Therapies clinic on the lower level of the main hospital for a one time visit. The visit will take approximately three to six hours.
During the visit, height and weight will be measured. Circumference measurements of the arms and legs will also be measured with a measuring tape. Bioimpedance analysis of the limb will be performed to assess the fluid content in the limbs.
Pain Ease numbing spray will have been applied to three injection sites on the affected arm or leg. 0.1ml of 0.25% Indocyanine green (ICG) dye will then be injected into the distal arm or leg at three separate sites: two interdigital injections and one injection in the volar wrist or posterior to the medial malleolus.
An immediate scan will be acquired using an ICG lymphography device. The scan will take approximately five minutes to complete. The data from this image will be considered baseline. This image is part of the patient's normal care at our institution and would be done even if the subject was not in this study.
The participant will then use the Nu-Step exercise machine for five minutes at a rate of perceived exertion (RPE) of 12-13. Heart rate will be monitored during the exercise with a pulse oximeter. After five minutes, a delayed scan will be performed with the NOVADAQ SPY Elite System and data will be recorded. The participant will continue to exercise for five minutes at an RPE of 12-13 and be scanned after every five minutes until the scans show no change in lymph pattern after two consecutive scans. The patient will be undergoing scanning and be exercising for a maximum of one hour.
Limb circumference measurements and bioimpedance scans will be repeated after exercise has been completed. The scan will be repeated every 1 hour until the normal 6-hour scan to monitor for further changes in the lymphatic pattern.
A post-intervention questionnaire will then be provided to the participant to complete discussing their exercise experience that day during the study, their previous ICG experiences, and their preference between this protocol and the current scanning process.
During the study, the subject will be told when he/she is being photographed/recorded. The injections and scans are clinically-indicated and would occur whether the individual was in the study or not. The initial and last scans are clinically indicated to determine disease status. 3) clarify how the follow-up survey is completed via email
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lymphedema | Other | Drug: Indocyanine GreenThe 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients
- Suspected lymphedema or previously diagnosed lymphedema
- Between the ages of 18-85 years old.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indocyanine GreenAlso: NOVADAQ SPY Elite System Indocyanine Green LymphographyThe 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. | Drug | Lymphedema |
Primary outcome
Time for Initial Disease Pattern to Appear
Time frame: 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.
After subjects exercise, this outcome will be measured by indocyanine green lymphography scans, a non-radioactive scan that visualizes the lymphatic system
1 secondary outcome
Time to Reach Indocyanine Green Lymphography Steady State
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27333213Dylke 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: PubMed 21791706Lee 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: PubMed 22675520Mihara 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: PubMed 27487485Chen 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: PubMed 21921744Yamamoto 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: PubMed 25488514Yamamoto 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: PubMed 23930436International 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: PubMed 16686578Johnson 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: PubMed 26440777Singh 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: PubMed 26266100Morris 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: PubMed 20863266Desai 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: PubMed 18361766Downey 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei F Chen, MD, FACS principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Indocyanine Green in people with Lymphedema, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time for Initial Disease Pattern to Appear (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03584633, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.