Breast Cancer FemalePhase 4NCT02982148
Methylene Blue Intradermal Injection for Sentinel Lymph Node Biopsy for Breast Cancer Patients
A Phase 4 study testing methylene blue intradermal injection and methylene blue subcutaneous injection in people with Breast Cancer Female and Early-Stage Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer Female, Early-Stage Breast Cancer, Sentinel Lymph Node
- What is being tested?
- methylene blue intradermal injection and methylene blue subcutaneous injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 1 siteChina
- Study dates
- May 2015to Jan 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- who sign the informed consent form
- pathological diagnosed, without distant metastasis, early stage invasive breast cancer patients
- did not undergo neoadjuvant chemotherapy, endocrinotherapy or targeted therapy previously
- without breast and axillary surgery history
- Ejection fraction score in normal range accord to cardiac doppler
- Eastern Cooperative Oncology Group score ≤0-2
- axillary lymph node clinical negative
Who cannot join
- pregnancy
- any history of malignant tumor within five years
- diagnosis of multi-center, multi-focal or bilateral breast cancer
- history of breast tumor incision biopsy or vacuum-assisted biopsy
- methylene blue allergic
- appear with severe systematic disease or disfunction of any organ
Trial locations and contacts
1 site in 1 country.
Kai Chen, M.D. contact
China1 site, 1 recruiting
- Recruiting
Sun-Yat-Sen Memorial Hospital of Sun-Yat-Sen University
Guangzhou, Guangdong, 510120
Kai Chen, M.D., 86-15920164730, chenkai23@mail.sysu.edu.cn
Erwei Song, M.D., Ph.D.
About this study
Official title: Comparison Between Intradermal Injection and Subcutaneous Injection With Methylene Blue for Sentinel Lymph Node Biopsy for Breast Cancer Patients
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.
Read the 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.
- Being tested
- methylene blue intradermal injection, methylene blue subcutaneous injection
- Keywords
- sentinel lymph node biopsy, methylene blue, intradermal injection, subcutaneous injection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylene blue intradermal injectionDevice
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.
methylene blue subcutaneous injectionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| methylene blue intradermal injection | Experimental | For patients randomized to intradermal injection before surgery began, 0.5ml 0.4% methylene blue(1ml methylene blue mixed up with 1.5ml saline) would be injected sub-areola (12 o'clock , 3 o'clock , 6 o'clock , 9 o'clock) intradermally, 0.1ml respectively, or peritumoral depending on the tumor location, 10-15 minutes before skin incision. The breast was massaged for 5 minutes to facilitate the identification of blue lymphatic vessels and the lymph nodes. Receives: Device: methylene blue intradermal injection |
| methylene blue subcutaneous injection | Active comparator | For patients randomized to subcutaneous injection before surgery began, 0.5ml 100% methylene blue would be injected sub-areola subcutaneously(12 o'clock , 3 o'clock , 6 o'clock , 9 o'clock), 0.1ml respectively or peritumoral depending on the tumor location, 10-15 minutes before skin incision. The breast was massaged for 5 minutes to facilitate the identification of blue lymphatic vessels and the lymph nodes. Receives: Device: methylene blue subcutaneous injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
detective rate of sentinel lymph node
Right after each of the sentinel lymph node biopsy, the investigators would collect data of whether it was successful or not and the amount of sentinel lymph nodes that shown out by the certain intervention.
Measured: through study completion, an average of 1.5 year
Secondary outcomes (2)
detective rate of blue lymphatic
The researcher would record if the surgeons could see blue lymphatic during the procedure of locating sentinel lymph node in use of the certain intervention.
Measured: through study completion, an average of 1.5 year
incidence of adverse events
One month after surgery, researchers would record if any adverse events appeared by phone call follow-up.
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study startMay 2015
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 352 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fengxi Su, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Fengxi Su, M.D., Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982148
- Sponsor's protocol ID
- SLNB5010
- Status last verified
- Nov 2016
- First submitted
- 29 Nov 2016
- Last updated
- 5 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Stradling B, Aranha G, Gabram S. Adverse skin lesions after methylene blue injections for sentinel lymph node localization. Am J Surg. 2002 Oct;184(4):350-2. doi: 10.1016/s0002-9610(02)00945-5.
PubMed 12383900Teknos D, Ramcharan A, Oluwole SF. Pulmonary edema associated with methylene blue dye administration during sentinel lymph node biopsy. J Natl Med Assoc. 2008 Dec;100(12):1483-4. doi: 10.1016/s0027-9684(15)31552-2.
PubMed 19110921Abdollahi A, Jangjoo A, Dabbagh Kakhki VR, Rasoul Zakavi S, Memar B, Naser Forghani M, Mehrabibahar M, Sadeghi R. Factors affecting sentinel lymph node detection failure in breast cancer patients using intradermal injection of the tracer. Rev Esp Med Nucl. 2010 Mar-Apr;29(2):73-7. doi: 10.1016/j.remn.2009.10.001. Epub 2009 Nov 22.
PubMed 19931946Golshan M, Nakhlis F. Can methylene blue only be used in sentinel lymph node biopsy for breast cancer? Breast J. 2006 Sep-Oct;12(5):428-30. doi: 10.1111/j.1075-122X.2006.00299.x.
PubMed 16958960Gumus M, Gumus H, Jones SE, Jones PA, Sever AR, Weeks J. How long will I be blue? Prolonged skin staining following sentinel lymph node biopsy using intradermal patent blue dye. Breast Care (Basel). 2013 Jun;8(3):199-202. doi: 10.1159/000352092.
PubMed 24415970Scheutz F. Drug addicts and local analgesia--effectivity and general side effects. Scand J Dent Res. 1982 Aug;90(4):299-305. doi: 10.1111/j.1600-0722.1982.tb00741.x.
PubMed 6957969
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Intradermal Injection and Subcutaneous Injection With Methylene Blue for Sentinel Lymph Node Biopsy for Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT02982148
- Acronym / sponsor ID
- SLNB5010
- Keywords
- sentinel lymph node biopsy, methylene blue, intradermal injection, subcutaneous injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 352 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| methylene blue intradermal injection | Experimental | Device: methylene blue intradermal injectionFor patients randomized to intradermal injection before surgery began, 0.5ml 0.4% methylene blue(1ml methylene blue mixed up with 1.5ml saline) would be injected sub-areola (12 o'clock , 3 o'clock , 6 o'clock , 9 o'clock) intradermally, 0.1ml respectively, or peritumoral depending on the tumor location, 10-15 minutes before skin incision. The breast was massaged for 5 minutes to facilitate the identification of blue lymphatic vessels and the lymph nodes. |
| methylene blue subcutaneous injection | Active comparator | Device: methylene blue subcutaneous injectionFor patients randomized to subcutaneous injection before surgery began, 0.5ml 100% methylene blue would be injected sub-areola subcutaneously(12 o'clock , 3 o'clock , 6 o'clock , 9 o'clock), 0.1ml respectively or peritumoral depending on the tumor location, 10-15 minutes before skin incision. The breast was massaged for 5 minutes to facilitate the identification of blue lymphatic vessels and the lymph nodes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- who sign the informed consent form
- pathological diagnosed, without distant metastasis, early stage invasive breast cancer patients
- did not undergo neoadjuvant chemotherapy, endocrinotherapy or targeted therapy previously
- without breast and axillary surgery history
- Ejection fraction score in normal range accord to cardiac doppler
Key exclusion criteria (6 listed)
- pregnancy
- any history of malignant tumor within five years
- diagnosis of multi-center, multi-focal or bilateral breast cancer
- history of breast tumor incision biopsy or vacuum-assisted biopsy
- methylene blue allergic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methylene blue intradermal injectionMethylene 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 intradermal injection |
| methylene blue subcutaneous injectionMethylene 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. | Device | methylene blue subcutaneous injection |
Primary outcome
detective rate of sentinel lymph node
Time frame: through study completion, an average of 1.5 year
Right after each of the sentinel lymph node biopsy, the investigators would collect data of whether it was successful or not and the amount of sentinel lymph nodes that shown out by the certain intervention.
2 secondary outcomes
detective rate of blue lymphatic
Time frame: through study completion, an average of 1.5 year
incidence of adverse events
Time frame: 1 month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2016.
- Background: PubMed 12383900Stradling B, Aranha G, Gabram S. Adverse skin lesions after methylene blue injections for sentinel lymph node localization. Am J Surg. 2002 Oct;184(4):350-2. doi: 10.1016/s0002-9610(02)00945-5.
- Background: PubMed 19110921Teknos D, Ramcharan A, Oluwole SF. Pulmonary edema associated with methylene blue dye administration during sentinel lymph node biopsy. J Natl Med Assoc. 2008 Dec;100(12):1483-4. doi: 10.1016/s0027-9684(15)31552-2.
- Background: PubMed 19931946Abdollahi A, Jangjoo A, Dabbagh Kakhki VR, Rasoul Zakavi S, Memar B, Naser Forghani M, Mehrabibahar M, Sadeghi R. Factors affecting sentinel lymph node detection failure in breast cancer patients using intradermal injection of the tracer. Rev Esp Med Nucl. 2010 Mar-Apr;29(2):73-7. doi: 10.1016/j.remn.2009.10.001. Epub 2009 Nov 22.
- Background: PubMed 16958960Golshan M, Nakhlis F. Can methylene blue only be used in sentinel lymph node biopsy for breast cancer? Breast J. 2006 Sep-Oct;12(5):428-30. doi: 10.1111/j.1075-122X.2006.00299.x.
- Background: PubMed 24415970Gumus M, Gumus H, Jones SE, Jones PA, Sever AR, Weeks J. How long will I be blue? Prolonged skin staining following sentinel lymph node biopsy using intradermal patent blue dye. Breast Care (Basel). 2013 Jun;8(3):199-202. doi: 10.1159/000352092.
- Background: PubMed 6957969Scheutz F. Drug addicts and local analgesia--effectivity and general side effects. Scand J Dent Res. 1982 Aug;90(4):299-305. doi: 10.1111/j.1600-0722.1982.tb00741.x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kai Chen, M.D. contact
Fengxi Su, M.D. principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing methylene blue intradermal injection and methylene blue subcutaneous injection in people with Breast Cancer Female and Early-Stage Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai Chen, M.D. (86-15920164730), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detective rate of sentinel lymph node (time frame: through study completion, an average of 1.5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02982148, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2016.