Breast CancerPhase 3IMSLNB-CANPNCT01668914
Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Positive
A Phase 3 study testing IM-SLNB, 99mTc-SC and Histologic Examination in people with Breast Cancer, run by Shandong Cancer Hospital and Institute at 1 site in China.
Trial summary
In addition to the axillary lymph nodes, the internal mammary lymph nodes (IMLNs) drainage is another important lymphatic channel of the breast. The status of IMLNs also provides important prognostic information for breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- IM-SLNB, 99mTc-SC and Histologic Examination
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- Feb 2014to Dec 2017
- Phase
- Phase 3
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary breast cancer
- clinically axilla-positive
Who cannot join
- enlarged internal mammary nodes by imaging
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III Trail of Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Positive
In addition to the axillary lymph nodes, the internal mammary lymph nodes (IMLNs) drainage is another important lymphatic channel of the breast. The status of IMLNs also provides important prognostic information for breast cancer patients. The technical evolvements of sentinel lymph node biopsy (SLNB) and lymphoscintigraphy provided a less invasive method for assessing IMLNs than surgical dissection. Recently, many study concerning IMSLNB was performed in the patients with clinically negative axillary nodes. However, previous published studies concerning patients with breast cancer who all underwent a radical mastectomy have shown that IMLN metastases are mostly found concomitantly with axillary metastases. For this reason, IM-SLNB is even more important for clinically axillary node-negative patients. To our knowledge, this is the first attempt of the IM-SLNB in early breast cancer patients with clinically positive axillary nodes.
Read the detailed description
OBJECTIVES:
- Determine the impact of routinely performed internal mammary sentinel lymph node biopsy on the systemic and locoregional treatments plan.
- Evaluate the metastasis rate of internal mammary sentinel lymph nodes in patients with clinically axillary node-positive.
- Draw the learning curve of internal mammary sentinel lymph node biopsy.
OUTLINE:
3~18 hours before surgery, under ultrasonographic guidance, 0.5~1.0 mCi 99mTc-labeled sulfur colloid in sterile saline (total volume 0.2~2.0 mL) is injected intraparenchymally into 2 quadrants of breast. Subsequently, lymphoscintigraphy is performed 0.5~1.0 hour before surgery. internal mammary sentinel lymph node biopsy is performed during the surgery and the internal mammary sentinel lymph nodes were sent to histologic examination.
- Conditions
- Breast Cancer
- Being tested
- IM-SLNB, 99mTc-SC, Histologic Examination, LSG, Methylthioninium
- Keywords
- Breast Cancer, Clinically Axillary Node -Positive, Sentinel Lymph Node Biopsy, Internal Mammary
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IM-SLNBProcedure or surgery
Also called Internal Mammary Sentinel Lymph Node Biopsy
IM-SLNB is performed according to the pre-operative lymphoscintigraphy
99mTc-SCRadiation
Also called 99mTc-labeled Sulfur Colloid
Two syringes of 0.25~0.5 mCi 99mTc-SC in 0.2~1.0 mL volume were injected intraparenchymally into 2 quadrants of breast, at the 6 and 12 o'clock positions.
Histologic ExaminationDevice
Also called hematoxylin-eosin staining and immunohistochemistry
All IMSLNs were analyzed by histologic examination for future therapy planning.
LSGDevice
Also called Lymphoscintigraphy
lymphoscintigraphy was performed 0.5~1.0 hour before surgery
MethylthioniniumDrug
Four milliliters of methylthioninium was injected intraparenchymally around the primary tumor 10 min before surgery
| Study group | Role | What they receive |
|---|---|---|
| clinically positive axillary nodes | Experimental | 3~18 hours before surgery, under ultrasonographic guidance, 0.5~1.0 mCi 99mTc-SC in sterile saline (total volume 0.2~2.0 mL) is injected intraparenchymally into 2 quadrants of breast. Subsequently, LSG is performed 0.5~1.0 hour before surgery. Methylthioninium was injected intraparenchymally. IM-SLNB is performed during the surgery and the IMSLNs were sent to histologic examination Receives: Procedure: IM-SLNB; Radiation: 99mTc-SC; Device: Histologic Examination; Device: LSG; Drug: Methylthioninium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB
Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB
Measured: 1 year
Secondary outcomes (2)
Visualization Rate of IMSLNs
visualization rate of internal mammary hotspots in lymphoscintigraphy
Measured: 1 year
Metastasis Rate of IMSLNs
Metastasis Rate of internal mammary sentinel lymph node
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study startFeb 2014
- Primary completionSep 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongsheng Wang, Shandong Cancer Hospital and Institute
- Investigators
- Yong-sheng Wang, MD, Study chair, Shandong Cancer Hospital and InstitutePeng-fei Qiu, MD, Principal investigator, Shandong Cancer Hospital and InstituteYan-bing Liu, MD, Principal investigator, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668914
- Sponsor's protocol ID
- IMSN002
- Acronym
- IMSLNB-CANP
- Status last verified
- Apr 2018
- First submitted
- 16 Aug 2012
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Trail of Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Positive
- ClinicalTrials.gov ID
- NCT01668914
- Acronym / sponsor ID
- IMSLNB-CANP / IMSN002
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Clinically Axillary Node -Positive, Sentinel Lymph Node Biopsy, Internal Mammary
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 20 Aug 2012 (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.
In addition to the axillary lymph nodes, the internal mammary lymph nodes (IMLNs) drainage is another important lymphatic channel of the breast. The status of IMLNs also provides important prognostic information for breast cancer patients. The technical evolvements of sentinel lymph node biopsy (SLNB) and lymphoscintigraphy provided a less invasive method for assessing IMLNs than surgical dissection. Recently, many study concerning IMSLNB was performed in the patients with clinically negative axillary nodes. However, previous published studies concerning patients with breast cancer who all underwent a radical mastectomy have shown that IMLN metastases are mostly found concomitantly with axillary metastases. For this reason, IM-SLNB is even more important for clinically axillary node-negative patients. To our knowledge, this is the first attempt of the IM-SLNB in early breast cancer patients with clinically positive axillary nodes.
Detailed description
OBJECTIVES:
- Determine the impact of routinely performed internal mammary sentinel lymph node biopsy on the systemic and locoregional treatments plan.
- Evaluate the metastasis rate of internal mammary sentinel lymph nodes in patients with clinically axillary node-positive.
- Draw the learning curve of internal mammary sentinel lymph node biopsy.
OUTLINE:
3~18 hours before surgery, under ultrasonographic guidance, 0.5~1.0 mCi 99mTc-labeled sulfur colloid in sterile saline (total volume 0.2~2.0 mL) is injected intraparenchymally into 2 quadrants of breast. Subsequently, lymphoscintigraphy is performed 0.5~1.0 hour before surgery. internal mammary sentinel lymph node biopsy is performed during the surgery and the internal mammary sentinel lymph nodes were sent to histologic examination.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| clinically positive axillary nodes | Experimental | Procedure: IM-SLNB, Radiation: 99mTc-SC, Device: Histologic Examination, Device: LSG, Drug: Methylthioninium3~18 hours before surgery, under ultrasonographic guidance, 0.5~1.0 mCi 99mTc-SC in sterile saline (total volume 0.2~2.0 mL) is injected intraparenchymally into 2 quadrants of breast. Subsequently, LSG is performed 0.5~1.0 hour before surgery. Methylthioninium was injected intraparenchymally. IM-SLNB is performed during the surgery and the IMSLNs were sent to histologic examination |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- primary breast cancer
- clinically axilla-positive
Key exclusion criteria (1 listed)
- enlarged internal mammary nodes by imaging
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 |
|---|---|---|
| IM-SLNBAlso: Internal Mammary Sentinel Lymph Node BiopsyIM-SLNB is performed according to the pre-operative lymphoscintigraphy | Procedure or surgery | clinically positive axillary nodes |
| 99mTc-SCAlso: 99mTc-labeled Sulfur ColloidTwo syringes of 0.25~0.5 mCi 99mTc-SC in 0.2~1.0 mL volume were injected intraparenchymally into 2 quadrants of breast, at the 6 and 12 o'clock positions. | Radiation | clinically positive axillary nodes |
| Histologic ExaminationAlso: hematoxylin-eosin staining and immunohistochemistryAll IMSLNs were analyzed by histologic examination for future therapy planning. | Device | clinically positive axillary nodes |
| LSGAlso: Lymphoscintigraphylymphoscintigraphy was performed 0.5~1.0 hour before surgery | Device | clinically positive axillary nodes |
| MethylthioniniumFour milliliters of methylthioninium was injected intraparenchymally around the primary tumor 10 min before surgery | Drug | clinically positive axillary nodes |
Primary outcome
Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB
Time frame: 1 year
Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB
2 secondary outcomes
Visualization Rate of IMSLNs
Time frame: 1 year
Metastasis Rate of IMSLNs
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
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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.
Yong-sheng Wang, MD study chair
Shandong Cancer Hospital and Institute
Peng-fei Qiu, MD principal investigator
Shandong Cancer Hospital and Institute
Yan-bing Liu, MD principal investigator
Shandong Cancer Hospital and Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IM-SLNB, 99mTc-SC and Histologic Examination in people with Breast Cancer, run by Shandong Cancer Hospital and Institute 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 5 Apr 2018. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Whose Lymph Node Staging was Changed with IM-SLNB (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2018.