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Cancer-treated patients receiving NIRFLI for Lymphedema

Phase 1

Waitlist Available

Led By Melissa B Aldrich, PhD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months after radiation

Awards & highlights

Study Summary

This trialaims to uncover how LE develops, so treatments can be developed to target its underlying causes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months after radiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months after radiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months after radiation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Lymphatic propulsive frequency as assessed by NIRFLI

Lymphatic propulsive velocity as assessed by NIRFLI

Percent extravascular dye as assessed by NIRFLI

+2 more

Secondary outcome measures

Chemokine levels as assessed by bead assay

Cytokine

Number of participants with autoimmune antibodies as assessed by ELISA

Trial Design

1Treatment groups

Experimental Treatment

Group I: Cancer-treated patients receiving NIRFLIExperimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Indocyanine green

FDA approved

Near-infrared Fluorescence Lymphatic Imaging (NIRFLI)

2017

Completed Phase 1

~80

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

903 Previous Clinical Trials

320,897 Total Patients Enrolled

2 Trials studying Lymphedema

303 Patients Enrolled for Lymphedema

M.D. Anderson Cancer CenterOTHER

2,966 Previous Clinical Trials

1,804,701 Total Patients Enrolled

3 Trials studying Lymphedema

610 Patients Enrolled for Lymphedema

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,073 Total Patients Enrolled

31 Trials studying Lymphedema

14,250 Patients Enrolled for Lymphedema

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant base for this research endeavor?

"The original clinical trial is no longer enrolling. It was posted on April 24th 2017, and the last update occurred in October 31st 2022. Fortunately, there are numerous other medical studies that may be suitable for those seeking treatment of lymphedema, with 76 actively recruiting patients while 30 more require participant recruitment."

Answered by AI

What potential hazards exist when using this treatment?

"As this is a first-stage clinical trial, limited data supporting the safety and efficacy of this treatment warrants it an initial score of 1."

Answered by AI

Is enrollment still open in this research project?

"Regrettably, the recruitment period for this clinical trial has ended. Initially posted on April 24th 2017 and most recently updated on October 31st 2022, there are no further opportunities for enrolment. However, if one is still looking to partake in a medical study related to lymphedema, 76 such trials are actively recruiting patients with 30 of them being dedicated towards this treatment specifically."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Lymphatic and Systemic Immunity Changes in Post-radiation Lymphedema Development

Melissa B Aldrich 2017. "Lymphatic and Systemic Immunity Changes in Post-radiation Lymphedema Development". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02949726.