Trials / Unknown
UnknownNCT02982148
Methylene Blue Intradermal Injection for Sentinel Lymph Node Biopsy for Breast Cancer Patients
Comparison Between Intradermal Injection and Subcutaneous Injection With Methylene Blue for Sentinel Lymph Node Biopsy for Breast Cancer Patients
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 352 (estimated)
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed to compare the effectiveness of intradermal injection and subcutaneous injection with methylene blue for early-stage breast cancer patients who need sentinel lymph node biopsy.
Detailed description
After fully informing and consent, patients recruited would be randomized 1:1 to intradermal injection group and subcutaneous injection group. Investigators aimed to find out the difference in sentinel lymph nodes detected rate, blue lymphatic detected rate and complication incidence between the two groups.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | methylene blue intradermal injection | Methylene blue has been prove to be effective and safe as a blue dye for sentinel lymph node biopsy in early breast cancer patient. But it was also reported by some article that adverse skin lesions appeared after methylene blue injections for sentinel lymph node localization. But the effectiveness and safety of methylene blue intradermal injection has not yet been investigated. |
| DEVICE | methylene blue subcutaneous injection | Methylene blue subcutaneous injection has become one of the standard method for sentinel lymph node biopsy for breast cancer patients. In such case, we use this method to be an active comparator for the intradermal injection group. |
Timeline
- Start date
- 2015-05-01
- Primary completion
- 2017-01-01
- Completion
- 2017-01-01
- First posted
- 2016-12-05
- Last updated
- 2016-12-05
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02982148. Inclusion in this directory is not an endorsement.