- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04292860
Reverse Axillary Mapping in Breast Radiation Treatment Planning
May 24, 2021 updated by: UNC Lineberger Comprehensive Cancer Center
Reverse Axillary Mapping as a Lymphedema Prevention Strategy in Breast Radiation Treatment Planning
The goal of this prospective study is to investigate the role of axillary reverse mapping (ARM) in radiation therapy planning of patients with breast cancer.
Lymphedema is a common side effect after surgery and radiation therapy for breast cancer.
The use of ARM is becoming more routine in surgery to differentiate the upper extremity lymphatics (UELs) from the breast axillary drainage to preferentially spare the UELs and reduce the rates of lymphedema.
Study Overview
Status
Withdrawn
Conditions
Study Type
Observational
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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Post-operative (lumpectomy or mastectomy) female breast cancer patients who will receive radiation to the whole breast or chest wall and the regional nodes.
Description
Inclusion Criteria:
- De novo presentation of post-operative (lumpectomy or mastectomy) female breast cancer patients to receive radiation to the whole breast or chest wall and the regional nodes. Patients who have received a sentinel lymph node (SLN) biopsy or an axillary lymph node dissection (ALND) will be eligible.
- Greater than or equal to 18 years of age (no upper age limit).
- Informed consent obtained.
Exclusion Criteria:
- Prisoners.
- Patients with metastatic breast cancer.
- Documented allergy to iodinated contrast
- Prior breast or axillary surgeries or radiation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Breast Cancer Pts
Post-operative (lumpectomy or mastectomy) female breast cancer patients who will receive radiation to the whole breast or chest wall and the regional nodes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Delineation of the upper extremity lymphatics (UEL) during the radiation treatment planning process using axillary reverse mapping (ARM)
Time Frame: Baseline to 1 year
|
ARM uses dye to track lymphatic flow of the upper extremities.We hypothesize that iodinated contrast injected into the upper inner arm (same site that surgeons inject during ARM) 15 minutes before the time of CT simulation will similarly be able to track the UELs.
We will contour the visible iodinated dye and will measure if that anatomically correlates with the general known location of the UELs.
Two radiation oncologists will independently determine if they can delineate the UELs.
If both radiation oncologists can identify and contour the UELs in a reproducible fashion, we will code the patient as "UEL identified."
If one or both physicians are either not able to identify the UEL on CT images or the contoured UEL structures are significantly different from each other, we will code the patient as "UEL not identified."
|
Baseline to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dosimetric endpoint
Time Frame: Baseline to 1 year
|
We will measure the Dmax, Dmin, Dmean, D25%, and D75%.
Dmax is the maximum dose (in units of Gray) delivered to the UEL, while Dmin is the minimum dose and Dmean is the mean dose.
D25% and D75% are the minimum dose delivered to 25% and 75% of the UEL, respectively.
We will also look at the percent of theoretical radiation plans that could be safely modified.
This will be a binary outcome: either the plan can be modified safely, or it cannot.
|
Baseline to 1 year
|
Lymphedema rate
Time Frame: Baseline to 5 years post-treatment
|
We will measure the lymphedema rates before the start of radiation and at 6 months, 12 months, 24 months, 36 months, and 60 months after the end of radiation therapy.
Arm circumference will be measured 15 cm above the medial epicondyle (upper arms) and 15 cm below the medial epicondyle (lower arms.
An increase in arm circumference of at least 10% in the lower arm or the upper arm, or both, compared with the contralateral arm at the same time-point will be considered clinically significant lymphedema.
|
Baseline to 5 years post-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dana Casey, UNC Chapel Hill
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 Major Dates
Study Start (ANTICIPATED)
May 1, 2021
Primary Completion (ANTICIPATED)
January 1, 2022
Study Completion (ANTICIPATED)
January 1, 2027
Study Registration Dates
First Submitted
February 27, 2020
First Submitted That Met QC Criteria
February 27, 2020
First Posted (ACTUAL)
March 3, 2020
Study Record Updates
Last Update Posted (ACTUAL)
May 27, 2021
Last Update Submitted That Met QC Criteria
May 24, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCCC1934
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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