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Loss of principal investigator
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot phase I and randomized phase II trial studies the best way to perform axillary lymph node preservation surgery and to see how well it works in preventing lymphedema in patients with breast cancer. Lymph node mapping may help in planning surgery to remove breast cancer and affected lymph nodes. It is not yet known whether reverse mapping guided axillary lymph node dissection is more effective than standard axillary lymph node dissection in preventing lymphedema.
PRIMARY OBJECTIVES: I. To produce a map of the lymphatic drainage of the upper extremity as it relates to breast drainage, to determine the proportion of women undergoing axillary lymphadenectomy at risk for lymphedema. II. To determine if blue lymphatics contain lymph node metastases. III. To evaluate the incidence of lymphedema and associated other surgical related quality of life in those undergoing this procedure as compared to the current standard of care.
OUTLINE: This is a phase I study followed by a randomized phase II study.
PILOT PORTION: Patients receive isosulfan blue dye subcutaneously (SC) and then undergo reverse mapping-guided axillary lymph node dissection.
RANDOMIZED PORTION: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive isosulfan blue dye subcutaneously (SC) and then undergo reverse mapping-guided axillary lymph node dissection. ARM II: Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.
After completion of study treatment, patients are followed up periodically.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (reverse mapping guided axillary lymph node dissection) | Experimental | Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection. |
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| Arm II (control) | Active Comparator | Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| axillary lymph node dissection | Procedure | Undergo reverse mapping-guided axillary lymph node dissection |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Arm Lymphatics Above, at, or Below the Axillary Vein | A Fisher's exact test with a one-sided alpha of 0.05 will be used to determine if the percentage of patients with arm lymphatics above, around, or below the axillary vein in the standard dissection group is superior to the experimental dissection group. | Up to 4 years |
| Percentage of Patients With Positive Axillary Reverse Mapping (ARM) Identified Nodes | A Fisher's exact test with a one-sided alpha of 0.05 will be used to determine if the percentage of patients with positive ARM identified nodes excised in the standard dissection group is superior to the experimental dissection group. | Up to 4 years |
| Percentage of Patients With Lymphedema | Difference between arms in patients developing lymphedema at any point during the study will be evaluated using chi-squared tests. | Up to 4 years |
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Inclusion Criteria:
- Patients diagnosed with breast cancer with a planned axillary lymph node dissection planned for breast cancer
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Chen, MD | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | United States | ||
| University of California, Davis Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection) | Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection. axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection isosulfan blue based lymphatic mapping quality-of-life assessment: Ancillary studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| isosulfan blue based lymphatic mapping | Drug |
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| axillary lymph node dissection | Procedure | Undergo standard axillary lymph node dissection |
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| quality-of-life assessment | Procedure | Ancillary studies |
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| Questionnaire administration | Other | Ancillary studies |
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| Sacramento |
| California |
| 95817 |
| United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599-1350 | United States |
| FG001 |
| Arm II (Control) |
Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC. isosulfan blue based lymphatic mapping axillary lymph node dissection: Undergo standard axillary lymph node dissection quality-of-life assessment: Ancillary studies Questionnaire administration: Ancillary studies |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection) | Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection. axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection isosulfan blue based lymphatic mapping quality-of-life assessment: Ancillary studies |
| BG001 | Arm II (Control) | Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC. isosulfan blue based lymphatic mapping axillary lymph node dissection: Undergo standard axillary lymph node dissection quality-of-life assessment: Ancillary studies Questionnaire administration: Ancillary studies |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Percentage of Patients With Arm Lymphatics Above, at, or Below the Axillary Vein | A Fisher's exact test with a one-sided alpha of 0.05 will be used to determine if the percentage of patients with arm lymphatics above, around, or below the axillary vein in the standard dissection group is superior to the experimental dissection group. | Because of early termination the study did not accrue the planned number of subjects. | Posted | Count of Participants | Participants | Up to 4 years |
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| Primary | Percentage of Patients With Positive Axillary Reverse Mapping (ARM) Identified Nodes | A Fisher's exact test with a one-sided alpha of 0.05 will be used to determine if the percentage of patients with positive ARM identified nodes excised in the standard dissection group is superior to the experimental dissection group. | Because of early termination the study did not accrue the planned number of subjects. | Posted | Count of Participants | Participants | Up to 4 years |
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| Primary | Percentage of Patients With Lymphedema | Difference between arms in patients developing lymphedema at any point during the study will be evaluated using chi-squared tests. | Because of early termination the study did not accrue the planned number of subjects. | Posted | Count of Participants | Participants | Up to 4 years |
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Adverse events were collected over a period of 28 months.
"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection) | Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection. axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection isosulfan blue based lymphatic mapping quality-of-life assessment: Ancillary studies Questionnaire administration: Ancillary studies | 1 | 18 | 13 | 18 | ||
| EG001 | Arm II (Control) | Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC. isosulfan blue based lymphatic mapping axillary lymph node dissection: Undergo standard axillary lymph node dissection quality-of-life assessment: Ancillary studies Questionnaire administration: Ancillary studies | 1 | 21 | 15 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Wound infection | Infections and infestations | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | Non-systematic Assessment |
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| Hearing impaired | Ear and labyrinth disorders | Non-systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | Non-systematic Assessment |
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| Edema limbs | General disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Fever | General disorders | Non-systematic Assessment |
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| Localized edema | General disorders | Non-systematic Assessment |
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| Pain | General disorders | Non-systematic Assessment |
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| Breast infection | Infections and infestations | Non-systematic Assessment |
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| Otitis media | Infections and infestations | Non-systematic Assessment |
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| Wound infection | Infections and infestations | Non-systematic Assessment |
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| Bruising | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| JP Drain Blood Leak | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Seroma | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Wound dehiscence | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Creatinine increased | Investigations | Non-systematic Assessment |
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| Glucose intolerance | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Hypoglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Chest wall pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Left Shoulder Joint Stiffness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Pain-post op | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | Non-systematic Assessment |
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| Depression | Psychiatric disorders | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | Non-systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | Non-systematic Assessment |
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| Breast Swelling | Reproductive system and breast disorders | Non-systematic Assessment |
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| Breast pain | Reproductive system and breast disorders | Non-systematic Assessment |
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| Vaginal hemorrhage | Reproductive system and breast disorders | Non-systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Erythema multiforme | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Rash acneiform | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Hematoma | Vascular disorders | Non-systematic Assessment |
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| Hypertension | Vascular disorders | Non-systematic Assessment |
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Study was terminated early due to loss of principal investigator. As a result accrual of subjects and data collection are incomplete.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carolyn Behrendt, Ph.D. | City of Hope | (626)359-8111 | 61148 | Cbehrendt@coh.org |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Male |
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| Counts |
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| Participants |
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