Breast CancerNCT04292860
Reverse Axillary Mapping in Breast Radiation Treatment Planning
An observational study of Breast Cancer and Lymphedema, run by UNC Lineberger Comprehensive Cancer Center.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Lymphedema
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2021to Jan 2027
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Prisoners.
- Patients with metastatic breast cancer.
- Documented allergy to iodinated contrast
- Prior breast or axillary surgeries or radiation.
About this study
Official title: 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.
- Conditions
- Breast Cancer, Lymphedema
- Keywords
- Lymphedema, Axillary Reverse Mapping, Breast Cancer
- Medical subject headings
- Breast Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Delineation of the upper extremity lymphatics (UEL) during the radiation treatment planning process using axillary reverse mapping (ARM)
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."
Measured: Baseline to 1 year
Secondary outcomes (2)
Dosimetric endpoint
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.
Measured: Baseline to 1 year
Lymphedema rate
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.
Measured: Baseline to 5 years post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study startMay 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJan 2027 (estimated)
Why it stopped: Principal Investigator decided not to move forward with the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dana Casey, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292860
- Sponsor's protocol ID
- LCCC1934
- Status last verified
- May 2021
- First submitted
- 27 Feb 2020
- Last updated
- 27 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reverse Axillary Mapping as a Lymphedema Prevention Strategy in Breast Radiation Treatment Planning
- ClinicalTrials.gov ID
- NCT04292860
- Acronym / sponsor ID
- LCCC1934
- Conditions
- Breast Cancer, Lymphedema
- Keywords
- Lymphedema, Axillary Reverse Mapping, Breast Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Principal Investigator decided not to move forward with the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Prisoners.
- Patients with metastatic breast cancer.
- Documented allergy to iodinated contrast
- Prior breast or axillary surgeries or radiation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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."
2 secondary outcomes
Dosimetric endpoint
Time frame: Baseline to 1 year
Lymphedema rate
Time frame: Baseline to 5 years post-treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dana Casey principal investigator
UNC Chapel Hill
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Lymphedema, run by UNC Lineberger Comprehensive Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delineation of the upper extremity lymphatics (UEL) during the radiation treatment planning process using axillary reverse mapping (ARM) (time frame: Baseline to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.