A Phase 2 interventional study of Methylene blue in Breast Cancer, sponsored by Louisiana State University Health Sciences Center in New Orleans. Completed at 2 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-06-20.
Sponsored by Louisiana State University Health Sciences Center in New Orleans · Phase 2, Interventional, and Diagnostic
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 62 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Louisiana State University Health Sciences Center in New Orleans is the lead sponsor of 70 studies on the registry; 12 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
One arm diagnostic
Drug: Methylene blue
1 mC1
Also known as: SNL biopsy, breast cancer biopsy
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
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
Superficial Skin Necrosis
the number of participants who developed post-operative skin necrosis within 2 weeks of surgery
Time frame: 2 weeks postoperatively
| Milestone | Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue |
|---|---|
| Started | 62 |
| Completed | 62 |
| Not completed | 0 |
| participants | Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue |
|---|---|
| Radioactive | 58 |
| Blue | 55 |
| Radioactive and Blue | 55 |
| Efferent blue lymphatics leading up to the SLN | 0 |
number of participants who had a systemic allergic reaction such as hives, shortness of breath, hypotension
| participants | Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue |
|---|---|
| Safety (Allergic Reaction to Blue Dye) | 0 |
the number of participants who developed post-operative skin necrosis within 2 weeks of surgery
| participants | Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue |
|---|---|
| Superficial Skin Necrosis | 2 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue | — | 0/62 (0%) | 2/62 (3.2%) |
| Event | Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue |
|---|---|
| superficial skin necrosisSkin and subcutaneous tissue disorders | 2/62 |
| Age, Categorical(Participants) | Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 55 |
| >=65 years | 7 |
| Sex: Female, Male(Participants) | Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue |
|---|---|
| Female | 62 |
| Male | 0 |
| Region of Enrollment(participants) | Sentinel Lymph Node Biopsy With Radiolabeled Methylene Blue |
|---|---|
| United States | 62 |
This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
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Louisiana State University Health Sciences Center in New Orleans