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NCT02949726

Lymphatic and Systemic Immunity Changes in Post-radiation Lymphedema Development

Completed Phase 1 Last updated 14 December 2023
What this trial tests

Phase 1 trial testing Indocyanine Green (ICG) in Lymphedema in 80 participants. Completed in 1 October 2022.

Timeline
24 April 2017
Primary endpoint
1 October 2022
1 October 2022

Quick facts

Lead sponsorThe University of Texas Health Science Center, Houston
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposebasic science
Enrollment80
Start date24 April 2017
Primary completion1 October 2022
Estimated completion1 October 2022
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

The University of Texas Health Science Center, Houston

Who can join

18 and older, female only, with Lymphedema. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Lymphatic function and anatomy in early stages of lipedema.
    Rasmussen JC, Aldrich MB, Fife CE, Herbst KL, et al · · 2022 · cited 29× · PMID 35707862 · DOI 10.1002/oby.23458
  2. The Development and Treatment of Lymphatic Dysfunction in Cancer Patients and Survivors.
    Aldrich MB, Rasmussen JC, Fife CE, Shaitelman SF, et al · · 2020 · cited 20× · PMID 32823928 · DOI 10.3390/cancers12082280
  3. Prediction of breast cancer-related lymphedema by dermal backflow detected with near-infrared fluorescence lymphatic imaging.
    Aldrich MB, Rasmussen JC, DeSnyder SM, Woodward WA, et al · · 2022 · cited 14× · PMID 35816269 · DOI 10.1007/s10549-022-06667-4
  4. Lymphatic pumping failure in the arm precedes dermal backflow and breast cancer-related lymphedema.
    Aldrich MB, McWain ME, Shaitelman SF, Kuhns RE, et al · · 2026 · PMID 41703640 · DOI 10.1186/s13058-026-02231-w

Verify or expand the search:

Other trials of Indocyanine Green (ICG)

Trials testing the same drug.

Other recruiting trials for Lymphedema

Currently open trials in the same condition.

Other The University of Texas Health Science Center, Houston trials

Trials by the same sponsor.

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Data sources for this page

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