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Lymphatic and Systemic Immunity Changes in Post-radiation Lymphedema Development

NCT ID: NCT02949726

Last Updated: 2023-12-14

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-24

Study Completion Date

2022-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Lymphedema

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cancer-treated patients receiving NIRFLI

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

Group Type OTHER

Indocyanine Green (ICG)

Intervention Type 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)

Intervention Type DEVICE

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

Interventions

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Indocyanine Green (ICG)

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

Intervention Type DRUG

Near-infrared Fluorescence Lymphatic Imaging (NIRFLI)

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Melissa B Aldrich

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Melissa B Aldrich, PhD

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

Site Status

Countries

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United States

Other Identifiers

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1R01CA201487-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC-MS-15-1021

Identifier Type: -

Identifier Source: org_study_id