Anatomic Stage III Breast Cancer AJCC v8NCT03941756
Lymphovenous Bypass Procedure Before Underarm Lymph Node Surgery in Preventing Lymphedema in Patients With Inflammatory or Locally Advanced Non-inflammatory Breast Cancer or Melanoma
A study testing Indocyanine Green, Lymphangiography and Lymphovenous Bypass in people with Anatomic Stage III Breast Cancer AJCC v8 and Breast Inflammatory Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This pilot trial studies whether a procedure called lymphovenous bypass would prevent lymphedema (arm swelling) in patients with inflammatory breast cancer or non-inflammatory breast cancer that has spread to nearby tissues or lymph nodes or melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anatomic Stage III Breast Cancer AJCC v8, Breast Inflammatory Carcinoma, Locally Advanced Breast Carcinoma
- What is being tested?
- Indocyanine Green, Lymphangiography and Lymphovenous Bypass
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2018to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients greater than or equal to 18 years of age.
- Patients willing to participate.
- Patients able to complete informed consent.
- Patients will be eligible for inclusion if they fall into one for two groups:
- Patients with inflammatory breast cancer, and those with locally advanced non-inflammatory breast cancer that are undergoing ALND and are anticipated to receive radiation therapy
- Or: Patients with a diagnosis of melanoma (including unknown primary) that will undergo ALND will also be eligible for inclusion in the study as a comparator group.
Who cannot join
- Patients taking anticoagulants within 7 days prior to surgery.
- Patients that are known to be pregnant at the time of surgery.
- Patients are available for follow-up less than 18 months or do not undergo measurements within the scheduled period.
- Patients with body mass index (BMI) greater than 50.0.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Mark Schaverien, 832-499-6321, sehull@mdanderson.org
Sara Hull, BSN,MHA,RN, 832-499-6321, sehull@mdanderson.org
About this study
Official title: Prophylactic Lymphovenous Bypass Procedure Following Axillary Lymphadenectomy: A Prospective Observational Study
This pilot trial studies whether a procedure called lymphovenous bypass would prevent lymphedema (arm swelling) in patients with inflammatory breast cancer or non-inflammatory breast cancer that has spread to nearby tissues or lymph nodes or melanoma. The lymphovenous bypass procedure creates a path for lymphatic fluid to flow away from the arms. It is usually done after a diagnosis of lymphedema. In this study, giving lymphovenous bypass before underarm lymph node surgery may help prevent lymphedema from forming.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the protective benefit to performing standard of care lymphovenous bypass (LVB) surgery at the time of standard of care axillary lymph node dissection (ALND) for patients that are high risk for developing breast-cancer related lymphedema (LE) of the upper extremity.
SECONDARY OBJECTIVES:
- Compare the medical outcomes for patients that received the LVB surgery with those receiving standard surgery in whom the intervention could not be performed.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive indocyanine green intravenously (IV) and undergo lymphangiography, then undergo LVB at the time of ALND.
GROUP II: Patients do not receive indocyanine green, undergo lymphangiography, nor undergo LVB at the time of ALND.
After completion of study, patients are followed up at 2 weeks, and then at 6, 12, and 18 months.
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Breast Inflammatory Carcinoma, Locally Advanced Breast Carcinoma, Melanoma
- Being tested
- Indocyanine Green, Lymphangiography, Lymphovenous Bypass
- Medical subject headings
- Inflammatory Breast Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine GreenDrug
Also called ICG
Given IV
LymphangiographyProcedure or surgery
Also called Lymphography
Undergo lymphangiography
Lymphovenous BypassProcedure or surgery
Also called Lymphovenous Anastomosis
Undergo LVB
| Study group | Role | What they receive |
|---|---|---|
| Group I (LVB) | Experimental | Patients receive indocyanine green IV and undergo lymphangiography, then undergo LVB at the time of ALND. Receives: Drug: Indocyanine Green; Procedure: Lymphangiography; Procedure: Lymphovenous Bypass |
| Group II (no intervention) | No intervention | Patients do not receive indocyanine green, undergo lymphangiography, nor undergo LVB at the time of ALND. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volumetric diagnosis of lymphedema
If the limb volume change, meets the criteria for a diagnosis of lymphedema at any time (5 percent, change), then the patient receives a diagnosis of lymphedema.
Measured: 18 months
Incidence of lymphedema
Will compare the incidence of lymphedema after mastectomy and axillary lymph node dissection surgery between two surgical techniques.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start14 Aug 2018
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage III Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Mark Schaverien, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03941756
- Sponsor's protocol ID
- 2018-0127
- Other IDs
- NCI-2019-02320, 2018-0127, P30CA016672
- Status last verified
- May 2026
- First submitted
- 6 May 2019
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Lymphovenous Bypass Procedure Following Axillary Lymphadenectomy: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03941756
- Acronym / sponsor ID
- 2018-0127
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Breast Inflammatory Carcinoma, Locally Advanced Breast Carcinoma, Melanoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Aug 2018 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 8 May 2019 (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.
This pilot trial studies whether a procedure called lymphovenous bypass would prevent lymphedema (arm swelling) in patients with inflammatory breast cancer or non-inflammatory breast cancer that has spread to nearby tissues or lymph nodes or melanoma. The lymphovenous bypass procedure creates a path for lymphatic fluid to flow away from the arms. It is usually done after a diagnosis of lymphedema. In this study, giving lymphovenous bypass before underarm lymph node surgery may help prevent lymphedema from forming.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the protective benefit to performing standard of care lymphovenous bypass (LVB) surgery at the time of standard of care axillary lymph node dissection (ALND) for patients that are high risk for developing breast-cancer related lymphedema (LE) of the upper extremity.
SECONDARY OBJECTIVES:
- Compare the medical outcomes for patients that received the LVB surgery with those receiving standard surgery in whom the intervention could not be performed.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive indocyanine green intravenously (IV) and undergo lymphangiography, then undergo LVB at the time of ALND.
GROUP II: Patients do not receive indocyanine green, undergo lymphangiography, nor undergo LVB at the time of ALND.
After completion of study, patients are followed up at 2 weeks, and then at 6, 12, and 18 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (LVB) | Experimental | Drug: Indocyanine Green, Procedure: Lymphangiography, Procedure: Lymphovenous BypassPatients receive indocyanine green IV and undergo lymphangiography, then undergo LVB at the time of ALND. |
| Group II (no intervention) | No intervention | –Patients do not receive indocyanine green, undergo lymphangiography, nor undergo LVB at the time of ALND. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients greater than or equal to 18 years of age.
- Patients willing to participate.
- Patients able to complete informed consent.
- Patients will be eligible for inclusion if they fall into one for two groups:
Key exclusion criteria (4 listed)
- Patients taking anticoagulants within 7 days prior to surgery.
- Patients that are known to be pregnant at the time of surgery.
- Patients are available for follow-up less than 18 months or do not undergo measurements within the scheduled period.
- Patients with body mass index (BMI) greater than 50.0.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indocyanine GreenAlso: ICGGiven IV | Drug | Group I (LVB) |
| LymphangiographyAlso: LymphographyUndergo lymphangiography | Procedure or surgery | Group I (LVB) |
| Lymphovenous BypassAlso: Lymphovenous AnastomosisUndergo LVB | Procedure or surgery | Group I (LVB) |
Primary outcome
Volumetric diagnosis of lymphedema
Time frame: 18 months
If the limb volume change, meets the criteria for a diagnosis of lymphedema at any time (5 percent, change), then the patient receives a diagnosis of lymphedema.
Incidence of lymphedema
Time frame: 18 months
Will compare the incidence of lymphedema after mastectomy and axillary lymph node dissection surgery between two surgical techniques.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
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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.
Mark Schaverien principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indocyanine Green, Lymphangiography and Lymphovenous Bypass in people with Anatomic Stage III Breast Cancer AJCC v8 and Breast Inflammatory Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
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 6 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: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volumetric diagnosis of lymphedema (time frame: 18 months). The study lists 2 primary outcomes in all. 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 26 May 2026.