Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-02323 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
Not provided
Not provided
Not provided
P.I. left
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Lymph node biopsy followed by axillary reverse mapping may reduce the incidence and severity of arm lymphedema. This randomized phase II trial is studying how well sentinel and/or axillary lymph node biopsy with or without axillary reverse mapping works in reducing incidence and severity of lymphedema in patients with resectable stage 0-II breast cancer
PRIMARY OBJECTIVES: I. To evaluate the ability of axillary reverse mapping (ARM) to reduce the incidence of lymphedema (LE) following axillary nodal staging. SECONDARY OBJECTIVES: I. To document the use of a standardized LE screening and LE level-specific management protocol on the outcome of LE among patients who develop LE. II. To document the relationship between limb volume measurements assessed by infrared laser perometry and bioelectrical impedance spectroscopy. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo and axillary reverse mapping. ARM II: Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. After completion of study treatment, patients are followed up at 1-2 weeks, 3 months, and then every 6 months for 4 years.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SNB plus ARM or ALND (+/- SNB) plus ARM | Experimental | Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping. |
|
| SNB or ALND (+/- SNB) | Active Comparator | Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| technetium Tc 99m sulfur colloid | Radiation | Given intradermally and periareolarly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Whether or Not a Patient Has Developed Grade 1+ LE | LE is defined using the CTCAE v3 definition: a >5-10% increase in the inter-limb volume in the ipsilateral arm compared to the unaffected arm. | During the first year post-operatively |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dennis Holmes | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
The study has no pre-assignment.
Recruitment for this trial opened in December 2010 and closed in June 2011 at which time the protocol was terminated due to the departure of the Principal Investigator.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SNB Plus ARM or ALND (+/- SNB) Plus ARM | Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping. technetium Tc 99m sulfur colloid: Given intradermally and periareolarly methylene blue: Given subcutaneously indocyanine green solution: Given subcutaneously sentinel lymph node biopsy: Undergo sentinel lymph node biopsy axillary lymph node biopsy: Undergo axillary lymph node biopsy bioimpedance spectroscopy: Correlative studies quality-of-life assessment: Ancillary studies lymphedema management: Undergo axillary reverse mapping |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| methylene blue | Drug | Given subcutaneously |
|
|
| indocyanine green solution | Drug | Given subcutaneously |
|
|
| sentinel lymph node biopsy | Procedure | Undergo sentinel lymph node biopsy |
|
|
| axillary lymph node biopsy | Procedure | Undergo axillary lymph node biopsy |
|
|
| bioimpedance spectroscopy | Procedure | Correlative studies |
|
|
| quality-of-life assessment | Procedure | Ancillary studies |
|
|
| lymphedema management | Other | Undergo axillary reverse mapping |
|
| FG001 | SNB or ALND (+/- SNB) | Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. technetium Tc 99m sulfur colloid: Given intradermally and periareolarly methylene blue: Given subcutaneously indocyanine green solution: Given subcutaneously sentinel lymph node biopsy: Undergo sentinel lymph node biopsy axillary lymph node biopsy: Undergo axillary lymph node biopsy bioimpedance spectroscopy: Correlative studies quality-of-life assessment: Ancillary studies |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SNB Plus ARM or ALND (+/- SNB) Plus ARM | Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping. technetium Tc 99m sulfur colloid: Given intradermally and periareolarly methylene blue: Given subcutaneously indocyanine green solution: Given subcutaneously sentinel lymph node biopsy: Undergo sentinel lymph node biopsy axillary lymph node biopsy: Undergo axillary lymph node biopsy bioimpedance spectroscopy: Correlative studies quality-of-life assessment: Ancillary studies lymphedema management: Undergo axillary reverse mapping |
| BG001 | SNB or ALND (+/- SNB) | Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. technetium Tc 99m sulfur colloid: Given intradermally and periareolarly methylene blue: Given subcutaneously indocyanine green solution: Given subcutaneously sentinel lymph node biopsy: Undergo sentinel lymph node biopsy axillary lymph node biopsy: Undergo axillary lymph node biopsy bioimpedance spectroscopy: Correlative studies quality-of-life assessment: Ancillary studies |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Whether or Not a Patient Has Developed Grade 1+ LE | LE is defined using the CTCAE v3 definition: a >5-10% increase in the inter-limb volume in the ipsilateral arm compared to the unaffected arm. | Unable to analyze due to early termination of the study | Posted | During the first year post-operatively |
|
|
Up to 6 months from date on study
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SNB Plus ARM or ALND (+/- SNB) Plus ARM | Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping. technetium Tc 99m sulfur colloid: Given intradermally and periareolarly methylene blue: Given subcutaneously indocyanine green solution: Given subcutaneously sentinel lymph node biopsy: Undergo sentinel lymph node biopsy axillary lymph node biopsy: Undergo axillary lymph node biopsy bioimpedance spectroscopy: Correlative studies quality-of-life assessment: Ancillary studies lymphedema management: Undergo axillary reverse mapping | 2 | 2 | 2 | 2 | ||
| EG001 | SNB or ALND (+/- SNB) | Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. technetium Tc 99m sulfur colloid: Given intradermally and periareolarly methylene blue: Given subcutaneously indocyanine green solution: Given subcutaneously sentinel lymph node biopsy: Undergo sentinel lymph node biopsy axillary lymph node biopsy: Undergo axillary lymph node biopsy bioimpedance spectroscopy: Correlative studies quality-of-life assessment: Ancillary studies | 2 | 2 | 2 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema - limbs | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Breast Pain | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Edema | General disorders | CTCAE (3.0) | Systematic Assessment | Mastectomy site |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Malaise | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Breast Pain | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
Study terminated early due to P.I. moving to another institution.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Victoria Soto, Project Specialist, Clinical Investigations Support Office | USC Norris Comprehensive Cancer Center | 323-226-6384 | victoria.soto@med.usc.edu |
| ID | Term |
|---|---|
| D008209 | Lymphedema |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013671 | Technetium Tc 99m Sulfur Colloid |
| D008751 | Methylene Blue |
| D007208 | Indocyanine Green |
| D021701 | Sentinel Lymph Node Biopsy |
| ID | Term |
|---|---|
| D013457 | Sulfur Compounds |
| D007287 | Inorganic Chemicals |
| D017556 | Technetium Compounds |
| D010640 | Phenothiazines |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008197 | Lymph Node Excision |
| D008919 | Investigative Techniques |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|