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LymphedemaPhase 1NCT02949726

Lymphatic and Systemic Immunity Changes in Post-radiation Lymphedema Development

A Phase 1 study testing Indocyanine Green (ICG) and Near-infrared Fluorescence Lymphatic Imaging (NIRFLI) in people with Lymphedema, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this study is to find out which immune molecules, cells, and genes are involved in the development of lymphedema (LE), so that medicines that target them can be considered for treating lymphedema. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Lymphedema
What is being tested?
Indocyanine Green (ICG) and Near-infrared Fluorescence Lymphatic Imaging (NIRFLI)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
24 Apr 2017to 1 Oct 2022
Phase
Phase 1
Are there results?
None posted in the registry

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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must be at least 18 years of age
  • Participants must have been clinically diagnosed with breast cancer and scheduled for axillary lymph node dissection (ALND) and radiation treatment at MD Anderson (receiving chemotherapy, mastectomy or breast-conserving surgery, ALND (>10 nodes) and radiation treatment for breast cancer, identified by Drs. Mittendorf and Shaitelman of the Nellie B. Connally Breast Cancer Center at MD Anderson)
  • Ambulatory and possessing all four limbs
  • No prior radiation therapy
  • Negative urine pregnancy test within 36 hours prior to study drug administration, if of childbearing potential
  • Females participants must complete the Female Enrollment Form. Childbearing potential participants must agree to use one of the medically accepted forms of contraception for a period of one month after study participation. Female participants who meet the criteria for non-childbearing will still complete the Female Enrollment Form, but are not restricted to the use of contraception following study participation.

Who cannot join

  • Participants with a known or suspected allergy to iodine
  • Participants who are breastfeeding, pregnant or trying to become pregnant
  • Severe underlying chronic illness or disease (other than breast cancer)
  • Participants not capable of keeping moderately still for the imaging portion of the study session (~1 hour for imaging)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

Other trials in United States

About this study

The goal of this study is to find out which immune molecules, cells, and genes are involved in the development of lymphedema (LE), so that medicines that target them can be considered for treating lymphedema. The hypothesis is that LE is a systemic, autoimmune-like disease that is initiated by inflammatory cytokines induced by surgery, radiation, and possibly chemotherapy in genetically susceptible patients.

Conditions
Lymphedema
Being tested
Indocyanine Green (ICG), Near-infrared Fluorescence Lymphatic Imaging (NIRFLI)
Medical subject headings
Lymphedema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Indocyanine Green (ICG)Drug

    Near-infrared Fluorescence Lymphatic Imaging (NIRFLI) using Indocyanine Green (ICG) is used to "visualize" lymphatic vessel anatomy and function.

  • Near-infrared Fluorescence Lymphatic Imaging (NIRFLI)Device

    Near-infrared Fluorescence Lymphatic Imaging (NIRFLI) using Indocyanine Green (ICG) is used to "visualize" lymphatic vessel anatomy and function.

Study groups in NCT02949726
Study groupRoleWhat they receive
Cancer-treated patients receiving NIRFLIOtherNear-infrared Fluorescence Lymphatic Imaging (NIRFLI) using Indocyanine Green (ICG) is used to "visualize" lymphatic vessel anatomy and function.
Receives: Drug: Indocyanine Green (ICG); Device: Near-infrared Fluorescence Lymphatic Imaging (NIRFLI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lymphatic propulsive velocity as assessed by NIRFLI

    Measured: immediately before surgery

  2. Lymphatic propulsive velocity as assessed by NIRFLI

    Measured: immediately before radiation (which is 6-8 weeks after surgery)

  3. Lymphatic propulsive velocity as assessed by NIRFLI

    Measured: 6 months after radiation

  4. Lymphatic propulsive velocity as assessed by NIRFLI

    Measured: 12 months after radiation

  5. Lymphatic propulsive velocity as assessed by NIRFLI

    Measured: 24 months after radiation

  6. Lymphatic propulsive frequency as assessed by NIRFLI

    Measured: immediately before surgery

  7. Lymphatic propulsive frequency as assessed by NIRFLI

    Measured: immediately before radiation (which is 6-8 weeks after surgery)

  8. Lymphatic propulsive frequency as assessed by NIRFLI

    Measured: 6 months after radiation

  9. Lymphatic propulsive frequency as assessed by NIRFLI

    Measured: 12 months after radiation

  10. Lymphatic propulsive frequency as assessed by NIRFLI

    Measured: 24 months after radiation

  11. Percent extravascular dye as assessed by NIRFLI

    Measured: immediately before surgery

  12. Percent extravascular dye as assessed by NIRFLI

    Measured: immediately before radiation (which is 6-8 weeks after surgery)

  13. Percent extravascular dye as assessed by NIRFLI

    Measured: 6 months after radiation

  14. Percent extravascular dye as assessed by NIRFLI

    Measured: 12 months after radiation

  15. Percent extravascular dye as assessed by NIRFLI

    Measured: 24 months after radiation

  16. Vessel tortuosity as assessed by NIRFLI

    Measured: immediately before surgery

  17. Vessel tortuosity as assessed by NIRFLI

    Measured: immediately before radiation (which is 6-8 weeks after surgery)

  18. Vessel tortuosity as assessed by NIRFLI

    Measured: 6 months after radiation

  19. Vessel tortuosity as assessed by NIRFLI

    Measured: 12 months after radiation

  20. Vessel tortuosity as assessed by NIRFLI

    Measured: 24 months after radiation

  21. Vessel dilation ratio as assessed by NIRFLI

    Measured: immediately before surgery

  22. Vessel dilation ratio as assessed by NIRFLI

    Measured: immediately before radiation (which is 6-8 weeks after surgery)

  23. Vessel dilation ratio as assessed by NIRFLI

    Measured: 6 months after radiation

  24. Vessel dilation ratio as assessed by NIRFLI

    Measured: 12 months after radiation

  25. Vessel dilation ratio as assessed by NIRFLI

    Measured: 24 months after radiation

Secondary outcomes (15)

  1. Chemokine levels as assessed by bead assay

    Measured: immediately before surgery

  2. Chemokine levels as assessed by bead assay

    Measured: immediately before radiation (which is 6-8 weeks after surgery)

  3. Chemokine levels as assessed by bead assay

    Measured: 6 months after radiation

  4. Chemokine levels as assessed by bead assay

    Measured: 12 months after radiation

  5. Chemokine levels as assessed by bead assay

    Measured: 24 months after radiation

  6. Cytokine levels as assessed by bead assay

    Measured: immediately before surgery

  7. Cytokine levels as assessed by bead assay

    Measured: immediately before radiation (which is 6-8 weeks after surgery)

  8. Cytokine levels as assessed by bead assay

    Measured: 6 months after radiation

  9. Cytokine levels as assessed by bead assay

    Measured: 12 months after radiation

  10. Cytokine levels as assessed by bead assay

    Measured: 24 months after radiation

  11. Number of participants with autoimmune antibodies as assessed by ELISA

    Measured: immediately before surgery

  12. Number of participants with autoimmune antibodies as assessed by ELISA

    Measured: immediately before radiation (which is 6-8 weeks after surgery)

  13. Number of participants with autoimmune antibodies as assessed by ELISA

    Measured: 6 months after radiation

  14. Number of participants with autoimmune antibodies as assessed by ELISA

    Measured: 12 months after radiation

  15. Number of participants with autoimmune antibodies as assessed by ELISA

    Measured: 24 months after radiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2016 (estimated)
  2. Study start24 Apr 2017
  3. Primary completion1 Oct 2022
  4. Study completion1 Oct 2022

Resources

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 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02949726
Sponsor's protocol ID
HSC-MS-15-1021
Other IDs
1R01CA201487-01A1
Status last verified
Dec 2023
First submitted
11 Jul 2016
Last updated
14 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Indocyanine Green (ICG) and Near-infrared Fluorescence Lymphatic Imaging (NIRFLI) in people with Lymphedema, run by The University of Texas Health Science Center, Houston 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 6 inclusion and 4 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 14 Dec 2023. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Lymphatic propulsive velocity as assessed by NIRFLI (time frame: immediately before surgery). The study lists 25 primary outcomes in all. 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 NCT02949726.

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 14 Dec 2023.

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