Breast Cancer
Conditions
Keywords
Breast cancer, diagnostic, lymph nodes
Brief summary
The purpose of this study is to develope a one-step procedure to perform a biopsy of axillary lymph nodes on the same side as the breast tumor in women diagnosed with breast cancer.
Detailed description
This study proposes the use of a newly developed experimental radioactive dye (radiolabeled methylene blue). On the day of surgery, the patient receives a single injection of the experimental radioactive dye after anesthesia. The injection will be in the location around the breast tumor. The surgeon makes a small cut in the armpit on the side of the cancer and is able to locate the lymh nodes that collect drainage from the cancerous area by detecting lymph nodes with higher radioactivity using a hand-held detector (a Geiger counter-like device) and/or visually identifying lymph nodes stained blue by the dye. These lymph nodes are then removed and analyzed by pathologists for the presence of cancer.
Interventions
DRUGMethylene blue
1 mC1
Sponsors
Louisiana State University Health Sciences Center in New Orleans
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Stage 0,I, II breast cancer * Clinical node status N0, N1 * No know allergy to iodine, lymphazurin or methylene blue dyes
Exclusion criteria
* Patient cannot be pregnant or nursing * Prisoners will not be eligible * Women under the age of 18 will not be eligible * Patients with a known allergy to iodine or methylene blue or lymphazurin blue dyes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Number of Participants That Have Sentinel Nodes Which Are Radioactive or Blue, or Radioactive and Blue or Have Efferent Blue Lymphatics Leading up to the Sentinel Node(s) | intraoperatively; up to 6 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety (Allergic Reaction to Blue Dye) | intraoperatively up to 6 hours | number of participants who had a systemic allergic reaction such as hives, shortness of breath, hypotension |
| Superficial Skin Necrosis | 2 weeks postoperatively | the number of participants who developed post-operative skin necrosis within 2 weeks of surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue One arm diagnostic using 1 mCi of 125-I Methylene blue dye to find sentinel lymph nodes | 62 |
| Total | 62 |
Baseline characteristics
| Characteristic | Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 55 Participants |
| Region of Enrollment United States | 62 participants |
| Sex: Female, Male Female | 62 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 62 |
| serious Total, serious adverse events | 0 / 62 |
Outcome results
Primary
The Number of Participants That Have Sentinel Nodes Which Are Radioactive or Blue, or Radioactive and Blue or Have Efferent Blue Lymphatics Leading up to the Sentinel Node(s)
Time frame: intraoperatively; up to 6 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue | The Number of Participants That Have Sentinel Nodes Which Are Radioactive or Blue, or Radioactive and Blue or Have Efferent Blue Lymphatics Leading up to the Sentinel Node(s) | Radioactive | 58 participants |
| Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue | The Number of Participants That Have Sentinel Nodes Which Are Radioactive or Blue, or Radioactive and Blue or Have Efferent Blue Lymphatics Leading up to the Sentinel Node(s) | Blue | 55 participants |
| Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue | The Number of Participants That Have Sentinel Nodes Which Are Radioactive or Blue, or Radioactive and Blue or Have Efferent Blue Lymphatics Leading up to the Sentinel Node(s) | Radioactive and Blue | 55 participants |
| Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue | The Number of Participants That Have Sentinel Nodes Which Are Radioactive or Blue, or Radioactive and Blue or Have Efferent Blue Lymphatics Leading up to the Sentinel Node(s) | Efferent blue lymphatics leading up to the SLN | 0 participants |
Secondary
Safety (Allergic Reaction to Blue Dye)
number of participants who had a systemic allergic reaction such as hives, shortness of breath, hypotension
Time frame: intraoperatively up to 6 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue | Safety (Allergic Reaction to Blue Dye) | 0 participants |
Secondary
Superficial Skin Necrosis
the number of participants who developed post-operative skin necrosis within 2 weeks of surgery
Time frame: 2 weeks postoperatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue | Superficial Skin Necrosis | 2 participants |