NCT02946021

Brief Summary

Assessment of lymphatic structure and function pre- and post- treatment and during recovery in head and neck cancer related lymphedema patients using NIR fluorescence lymphatic imaging: Response to ICD therapy in HNC Patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 26, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 20, 2019

Completed
Last Updated

April 9, 2019

Status Verified

March 1, 2019

Enrollment Period

1.3 years

First QC Date

October 20, 2016

Results QC Date

February 26, 2019

Last Update Submit

March 28, 2019

Conditions

Head and Neck NeoplasmsHead and Neck LymphedemaHead and Neck Cancer

Keywords

LymphedemaCancerHead CancerNeck Cancer

Outcome Measures

Primary Outcomes (1)

  • Lymph Movement Measured by ICG Lymphography.

    Demonstrate the ability of the Flexitouch system to move lymph/enhance lymphatic uptake (indicated by increased functionality of vessels and/or changes in area of dermal backflow) as measured by Indocyanine Green (ICG) lymphography.

    Single Treatment, 2 Weeks of Treatment

Secondary Outcomes (3)

  • Dermal Backflow Measured by ICG Lymphography.

    Single Treatment, 2 Weeks of Treatment

  • Symptom Alleviation Measured by Survey Response.

    Single Treatment, 2 Weeks of Treatment

  • Ease of Use Measured by Survey Response.

    Single Treatment, 2 Weeks of Treatment

Study Arms (2)

Pneumatic Compression-1 session per day

EXPERIMENTAL

Head and neck garments for pneumatic compression device for treatment of lymphedema (1 session per day) with imaging using NIRFLI with ICG (Indocyanine green).

Device: Head and neck garments for pneumatic compression deviceDrug: NIRFLI with ICG

Pneumatic Compression-2 sessions per day

EXPERIMENTAL

Head and neck garments for pneumatic compression device for treatment of lymphedema (2 sessions per day) with imaging using NIRFLI with ICG (Indocyanine green).

Device: Head and neck garments for pneumatic compression deviceDrug: NIRFLI with ICG

Interventions

Head and neck garments for pneumatic compression deviceDEVICE

Pneumatic compression device cleared for use by patients who are under medical supervision for the treatment of 1) lymphedema (primary or secondary); 2) edema resulting from mastectomies, trauma, sports injuries or post immobilization; 3) venous insufficiencies; 4) wounds; and 5) stasis dermatitis, venous stasis ulcers, arterial leg ulcers and diabetic foot ulcers and treatment of head and neck lymphedema

Also known as: Flexitouch system
Pneumatic Compression-1 session per dayPneumatic Compression-2 sessions per day
NIRFLI with ICGDRUG

Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to dynamically follow lymphatic movement in subjects.

Also known as: Near Infrared Fluorescence Imaging with Indocyanine Green
Pneumatic Compression-1 session per dayPneumatic Compression-2 sessions per day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must be 18 years of age or older
  • Participants must be diagnosed with Lymphedema of the Head and/or Neck
  • Participants must be diagnosed with squamous cell carcinoma of the oral cavity, oropharynx or larynx and underwent surgery and radiation as part of their standard-of-care treatment plan.
  • Participants must be ≥ 4 weeks post-radiation therapy
  • Female participants of childbearing potential must have a negative urine pregnancy test ≤ 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 after each imaging session
  • Participants must be willing to use the Flexitouch® System at home daily for two (2) weeks

You may not qualify if:

  • Women who are pregnant or breast-feeding
  • Persons who are allergic to iodine
  • A female of child-bearing potential, who does not agree to use an approved contraceptive for one month after study participation
  • Persons with pulmonary edema, thrombophlebitis, congestive heart failure, deep vein thrombosis, episodes of pulmonary embolism, infections and inflammation, or acute cancer
  • Persons with uncontrolled hyperthyroidism or parathyroidism (for with an endocrinologist recommends against neck compression)
  • Carotid sinus hypersensitivity syndrome
  • Symptomatic carotid artery disease, as manifested by a recent transient ischemic attack (within 30 days), ischemic stroke, or amaurosis fugax (monocular visual ischemic symptoms or blindness)
  • Symptomatic bradycardia in the absence of a pacemaker
  • Internal jugular venous thrombosis, acute or within 3 months
  • Known intracranial pressure or other contraindication to internal or external jugular venous compression
  • Acute radiation dermatitis, unhealed surgical scar, unhealed or open wound(s), surgical flap less than 6-8 weeks post-operative
  • Facial or head and neck dermal metastasis
  • Acute facial infection (e.g., facial or parotid gland abscess)
  • Any condition where increased venous and lymphatic return is undesirable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsLymphedemaNeoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Neoplasms by SiteLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Limitations and Caveats

One subject reported wearing the head garment upside down during the two week treatment period, therefore the subject was excluded from the analysis population and replaced with another subject to meet the requirement for 10 analyzable data sets.

Results Point of Contact

Title
Jill Christensen
Organization
Tactile Medical
jchristensen@tactilemedical.com
(612) 355-5123

Study Officials

  • John Rasmussen, PhD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2016

First Posted

October 26, 2016

Study Start

October 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

April 9, 2019

Results First Posted

March 20, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)