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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2019-02320 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2018-0127 | Other Identifier | M D Anderson Cancer Center | |
| P30CA016672 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
PRIMARY OBJECTIVES:
I. 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:
I. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (LVB) | Experimental | Patients 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine Green | Drug | Given IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 18 months |
| Incidence of lymphedema | Will compare the incidence of lymphedema after mastectomy and axillary lymph node dissection surgery between two surgical techniques. | 18 months |
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Inclusion Criteria:
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Schaverien | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Lymphangiography |
| Procedure |
Undergo lymphangiography |
|
|
| Lymphovenous Bypass | Procedure | Undergo LVB |
|
|
| ID | Term |
|---|---|
| D058922 | Inflammatory Breast Neoplasms |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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