RECRUITING

Lymphedema Prevention Through Immediate Lymphatic Reconstruction (LILY) Trial.

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To learn if reconstruction of the lymphatic system at the time of axillary lymphadenectomy can reduce the risk of developing lymphedema.

Official Title

Lymphedema Prevention Through Immediate Lymphatic Reconstruction (LILY) Trial

Quick Facts

Study Start:2024-09-24

Study Completion:2029-08-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06989099

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Participants diagnosed with IBC. 2. Participants who have been scheduled for ILR/pLVB by their treating physician/surgeon at the time of their axillary lymphadenectomy for breast cancer 3. Participants willing and able to comply with the study protocol requirements and all study-related visit requirements. 4. Female subjects at least 18 years old and capable of providing consent to participate. 5. Females of childbearing potential must have a negative urine pregnancy test within 36 hours prior to study drug administration and agree to use a medically accepted method of contraception for a period of one month following the study.	1. Patients known to be pregnant or breast-feeding. 2. Patients with known or suspected iodine or ICG hypersensitivity. 3. Patients unable to remain stationary for one hour. 4. Active cellulitis. 5. Subjects with a preoperative clinical lymphedema diagnosis. 6. Subjects undergoing bilateral ALND. 7. Subjects requiring immediate chest wall reconstruction with a pedicled or microvascular flap, or those that have received preoperative radiation therapy. 8. Patients with BMI \>45kg/m2.

Inclusion Criteria

Exclusion Criteria

1. Participants diagnosed with IBC.
2. Participants who have been scheduled for ILR/pLVB by their treating physician/surgeon at the time of their axillary lymphadenectomy for breast cancer
3. Participants willing and able to comply with the study protocol requirements and all study-related visit requirements.
4. Female subjects at least 18 years old and capable of providing consent to participate.
5. Females of childbearing potential must have a negative urine pregnancy test within 36 hours prior to study drug administration and agree to use a medically accepted method of contraception for a period of one month following the study.

1. Patients known to be pregnant or breast-feeding.
2. Patients with known or suspected iodine or ICG hypersensitivity.
3. Patients unable to remain stationary for one hour.
4. Active cellulitis.
5. Subjects with a preoperative clinical lymphedema diagnosis.
6. Subjects undergoing bilateral ALND.
7. Subjects requiring immediate chest wall reconstruction with a pedicled or microvascular flap, or those that have received preoperative radiation therapy.
8. Patients with BMI \>45kg/m2.

Contacts and Locations

Study Contact

Sara Hull, MHA, BA, BSN, RN, CCRP

CONTACT

713-794-1247

sehull@mdanderson.org

Principal Investigator

Mark Schaverien, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Mark Schaverien, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-24

Study Completion Date2029-08-01

Study Record Updates

Study Start Date2024-09-24

Study Completion Date2029-08-01

Terms related to this study

Additional Relevant MeSH Terms

Lymphedema