Ignite Creation Date:
2025-12-25 @ 5:18 AM
Ignite Modification Date:
2026-03-05 @ 1:11 AM
Study NCT ID:
NCT03927027
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-17
First Post:
2019-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Axillary Reverse Mapping in Preventing Lymphedema in Patients with Breast Cancer Undergoing Axillary Lymph Node Dissection
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Study Overview
Official Title:
ARM: Axillary Reverse Mapping - a Prospective Trial to Study Rates of Lymphedema and Regional Recurrence After Sentinel Lymph Node Biopsy and Sentinel Lymph Node Biopsy Followed by Axillary Lymph Node Dissection with and Without Axillary Reverse Mapping
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase III trial studies how well axillary reverse mapping works in preventing lymphedema in patients with breast cancer undergoing axillary lymph node dissection. Axillary reverse mapping may help to preserve the lymph node drainage system around the breast so as to prevent lymphedema after surgery.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the occurrence of post-surgery lymphedema by conical geometric measures in clinical T1-3, N0-3, M0 breast cancer patients undergoing axillary surgery and randomized to Group 1 (no axillary reverse mapping \[ARM\]) versus Group II (ARM).
SECONDARY OBJECTIVES:
I. To compare between the study groups the lymphedema symptom intensity and distress as measured by the Lymphedema Symptom Intensity and Distress Survey-Arm (LSIDS-A).
II. To evaluate the technical success of performance of ARM procedure: Identification of ARM lymphatics, and the ability to spare or reapproximate ARM lymphatics.
III. To compare the rate of regional recurrence between patients randomized to receive ARM versus no ARM.
EXPLORATORY OBJECTIVES:
I. To assess the occurrence of lymphedema as a function of radiotherapy use and targets.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive isosulfan blue subcutaneously (SC) and undergo axillary lymph node dissection (ALND).
GROUP II: Patients undergo ARM. Patients then receive isosulfan blue and undergo ALND as in Group I.
After completion of study, patients are followed up for 3 years.
I. To determine the occurrence of post-surgery lymphedema by conical geometric measures in clinical T1-3, N0-3, M0 breast cancer patients undergoing axillary surgery and randomized to Group 1 (no axillary reverse mapping \[ARM\]) versus Group II (ARM).
SECONDARY OBJECTIVES:
I. To compare between the study groups the lymphedema symptom intensity and distress as measured by the Lymphedema Symptom Intensity and Distress Survey-Arm (LSIDS-A).
II. To evaluate the technical success of performance of ARM procedure: Identification of ARM lymphatics, and the ability to spare or reapproximate ARM lymphatics.
III. To compare the rate of regional recurrence between patients randomized to receive ARM versus no ARM.
EXPLORATORY OBJECTIVES:
I. To assess the occurrence of lymphedema as a function of radiotherapy use and targets.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive isosulfan blue subcutaneously (SC) and undergo axillary lymph node dissection (ALND).
GROUP II: Patients undergo ARM. Patients then receive isosulfan blue and undergo ALND as in Group I.
After completion of study, patients are followed up for 3 years.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2018-02445 | REGISTRY | NCI Clinical Trial Reporting Program | View | |
| UG1CA189823 | NIH | None | https://reporter.nih.gov/quic… | View |