Near-infrared Fluorescence Lymphatic Imaging Assessment of Lymphatic Response to Pneumatic Back/Neck Lymphatic Drainage Delivered by a Pneumatic Manual Lymphatic Drainage Device
NCT ID: NCT05946837
Last Updated: 2023-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
4 participants
INTERVENTIONAL
2023-08-29
2023-09-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pneumatic Compression Therapy (PCT)
Indocyanine green (ICG) dye
ICG (25 mg vial) will be reconstituted with 10 ml sterile water provided by the manufacturer; further dilutions will be made in sterile saline just prior to administration. The final concentration of 0.32 millimolar (mM) will provide 25 μg ICG/injection, with each injection of 0.1 cc to be made . Up to 30 intradermal injections using conventional 30- or 31-gauge needles will be administered to each subject, for a maximum dose of 750 ug ICG, over 200 times less than the maximum allowed dose. Injection sites will be cleaned with alcohol wipes before intradermal injection.
NIRF-LI imaging
Near-infrared fluorescence lymphatic imaging (NIRF-LI) imaging will be done to assess the drainage of ICG laden lymph from ICG injection sites toward regional nodal basins for 60 minutes before, during and after the Neuroglide pad treatment
Neuroglide pad
After injection of Indocyanine green (ICG) dye and NIRF-LI imaging the subject will lie on the Neuroglide pad for the one-hour PCT treatment session.
Interventions
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Indocyanine green (ICG) dye
ICG (25 mg vial) will be reconstituted with 10 ml sterile water provided by the manufacturer; further dilutions will be made in sterile saline just prior to administration. The final concentration of 0.32 millimolar (mM) will provide 25 μg ICG/injection, with each injection of 0.1 cc to be made . Up to 30 intradermal injections using conventional 30- or 31-gauge needles will be administered to each subject, for a maximum dose of 750 ug ICG, over 200 times less than the maximum allowed dose. Injection sites will be cleaned with alcohol wipes before intradermal injection.
NIRF-LI imaging
Near-infrared fluorescence lymphatic imaging (NIRF-LI) imaging will be done to assess the drainage of ICG laden lymph from ICG injection sites toward regional nodal basins for 60 minutes before, during and after the Neuroglide pad treatment
Neuroglide pad
After injection of Indocyanine green (ICG) dye and NIRF-LI imaging the subject will lie on the Neuroglide pad for the one-hour PCT treatment session.
Eligibility Criteria
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Inclusion Criteria
* Female participants of childbearing potential must have a negative urine pregnancy test within 36 hours prior to study drug administration
* Female participants of childbearing potential must agree to use a medically accepted method of contraception for a period of one month following each imaging session in the study
* Weight less than 400 lbs
Exclusion Criteria
* Persons who are allergic to iodine or indocyanine green
* Heart failure, poorly controlled kidney disease (glomerular filtration rate \<30 mls per minute), hypoproteinemia, pulmonary hypertension, or hypothyroidism
* Any circumstance where increased lymphatic or venous return is undesirable
18 Years
ALL
No
Sponsors
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Eva MedTech, Inc.
UNKNOWN
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Melissa B Aldrich
Associate Professor
Principal Investigators
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Melissa B Aldrich, PhD, MBA
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Other Identifiers
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HSC-MS-23-0093
Identifier Type: -
Identifier Source: org_study_id