Ignite Creation Date:
2024-05-06 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03584633
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2019-09-27
First Post:
2018-06-05
Brief Title:
Effect of Exercise on Indocyanine Green ICG Lymphography Imaging
Sponsor:
Wei Chen
Organization:
University of Iowa
Study Overview
Official Title:
Standardization of Indocyanine Green Lymphography Protocol With Exercise for Lymphedema Assessment
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 ie 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 01ml of 025 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 patients 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 heshe is being photographedrecorded 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 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 01ml of 025 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 patients 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 heshe is being photographedrecorded 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None