Effect of Exercise on Indocyanine Green (ICG) Lymphography Imaging
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Breast Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 8/16/2018 |
| Start Date: | November 3, 2018 |
| End Date: | December 31, 2019 |
| Contact: | Wei F Chen, MD, FACS |
| Email: | wei-chen@uiowa.edu |
| Phone: | (319) 384-8129 |
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.
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 & BP) 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 10-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 physical therapist)
- Second scan & vitals
- 3-minute period of exercise
- Third scan & vitals
o Continue 3-minute exercise period followed by scan & vitals until disease pattern
emerges
* Exercise for 3 minutes then scan and vitals until images reach steady state for two
consecutive scans
- Final vitals (HR & BP)
- Exit survey
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 & BP) 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 10-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 physical therapist)
- Second scan & vitals
- 3-minute period of exercise
- Third scan & vitals
o Continue 3-minute exercise period followed by scan & vitals until disease pattern
emerges
* Exercise for 3 minutes then scan and vitals until images reach steady state for two
consecutive scans
- Final vitals (HR & BP)
- Exit survey
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 ten minutes at a rate of
perceived exertion (RPE) of 12-13. Heart rate will be monitored during the exercise with a
pulse oximeter. After ten 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 three
minutes at an RPE of 12-13 and be scanned after every three 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 exercising has
been completed. If the scans do not reach a steady state after one hour, the patient will be
scanned five hours later per standard procedure at this institution.
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
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 ten minutes at a rate of
perceived exertion (RPE) of 12-13. Heart rate will be monitored during the exercise with a
pulse oximeter. After ten 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 three
minutes at an RPE of 12-13 and be scanned after every three 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 exercising has
been completed. If the scans do not reach a steady state after one hour, the patient will be
scanned five hours later per standard procedure at this institution.
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
Inclusion Criteria:
- Female patients
- Suspected lymphedema or previously diagnosed lymphedema
- Between the ages of 18-85 years old.
Exclusion Criteria:
- 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.
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