Breast CancerNCT03541278
Internal Mammary Sentinel Lymph Node Biopsy With Modified Injection Technique
A study testing MIT and IM-SLNB in people with Breast Cancer, run by Shandong Cancer Hospital and Institute at 1 site in China.
Trial summary
Internal Mammary Lymph Node (IMLN) and Axillary Lymph Node (ALN) are regarded as "the first station" of lymphatic drainage in breast cancer, serving as an important reference for lymph staging and decision-making. 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?
- MIT and IM-SLNB
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 31 Dec 2020
- Phase
- Interventional
- 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
- Patients with preoperative pathology confirmed invasive breast cancer;
- Clinical T1-3 N0-3 M0 (with positive fine-needle aspiration result in their clinical or ultrasonic suspicious axillary lymph node ; no clinical or radiologic evidence of distant metastases);
- Be able and willing to sign informed consent forms.
Who cannot join
- Patients with enlarged internal mammary nodes by imaging;
- Patients who have received neoadjuvant therapy (including neoadjuvant chemotherapy and / or endocrine therapy);
- Patients with a previous history of breast cancer (recurrence of breast cancer and contralateral breast cancer);
- Patients with a history of other malignancies;
- Patients who have had previous surgery in axillary or internal mammary;
- Patients in pregnancy and lactation;
- Patients participant in other clinical trials that will have an impact on the results of this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong Cancer Hospital and Institute
Jinan, Shandong, 250117
Yong-Sheng Wang, MD, +8613505409989, wangysh2008@aliyun.com
About this study
Official title: A Prospective Multicenter Clinical Trial of Internal Mammary Sentinel Lymph Node Biopsy With Modified Injection Technique for Early Breast Cancer
Internal Mammary Lymph Node (IMLN) and Axillary Lymph Node (ALN) are regarded as "the first station" of lymphatic drainage in breast cancer, serving as an important reference for lymph staging and decision-making. Although the concept of Internal Mammary Sentinel Lymph Node Biopsy (IM-SLNB) has been included in the AJCC guidelines since the 6th edition, technical bottlenecks and clinical benefits still remained to be the main reasons limiting its clinical application:
Technical bottlenecks: In previous clinical practice, the internal mammary visualization rate was very low (13% on average, 0% -37%) under the guidance of the traditional radionuclide injection technique, which became a technology bottleneck restricting the widespread of IM-SLNB. After continuous exploration, our center invented the "modified injection technique" of injecting the nuclide tracer into the mammary gland layer at 6 and 12 o'clock around the areolar under the guidance of ultrasound, as well as increasing the injection volume to increase the local tension. A high internal mammary imaging rate of 71% was obtained, which laid a foundation for the further study and clinical application of IM-SLNB.
Read more
Clinical benefits: The IM-SLNB is a method to assess IMLN metastatic status in a minimally invasive way, which may improve the system of regional staging and guide precise IMLN treatment. However, based on the current IM-SLNB indication, the internal mammary metastasis rate was only 8%-15%, and it only had little influence on treatment strategy, which led to the controversy of its clinical application. Previous studies of extended radical mastectomy showed that in ALN positive patients the IMLN metastasis rate was 28-52%, while in ALN negative patients the metastasis rate was only 5-17%. Therefore, the continuation of the previous A-SLNB indication (clinical ALN negative) to IM-SLNB is apparently not in line with the current clinical practice, but further evaluation of internal mammary metastasis status in clinical ALN positive patients may receive greater benefit.
This prospective multicenter study attempted to perform IM-SLNB with our modified injection technique both in clinical ALN negative and positive patients for the first time. Through analyzing metastasis rate of IMLN as well as the influences it had on decision making, we hoped to develop more accurate indication for IM-SLNB and guide the individualized precise treatment of IMLN.
Read the detailed description
Tracer injection and Lymphatic imaging: The radionuclide tracer (99mTc-Sulfur colloid) was prepared by the Nuclear Medicine Department and the sulfur colloid kit (equipped with a filter of 220 nm in diameter to control the size of colloidal particles) was prepared by Beijing Xinkesida company. All patients were injected with 99mTc-Sulfur colloid (1.0~1.2ml/29.6~55.5MBq) in periareolar parenchyma gland under the guidance of ultrasound using the "new injection technique" 3-18h before surgery. SPECT / CT lymphoscintigraphy was performed 30 min before surgery, and the radioactive concentration ("hot spot") near the sternum was defined as IMSLN positive.
IM-SLNB: After modified radical mastectomy / breast-conserving radical surgery, intraoperative γ-detector (Neoprobe 2000, Johnson\& Johnson Company) was used to locate IM-SLN, and intercostal IM-SLNB was performed: open pectoralis major muscle, expose the parasternal intercostal space at the corresponding intercostal level (if the patient underwent breast-conserving surgery and the tumor was located in the lateral quadrant, an additional 3 cm of skin incision was required), cut the intercostal muscle at radioactive concentration site parallel to the rib, search and locate IMSLN with gamma detector, dissect precisely to avoid injury of internal mammary arteries and veins, and then sent the removed tissue to routine pathological examination.
Pathologic diagnosis: IMSLN was divided into 2mm tissue fragments according to the long axis (short diameter < 2 mm, no division), every tissue fragment required one layer of routine HE staining pathological examination. In this study, metastasis > 0.2mm was defined as IMSLN positive, while solitary tumor cell was defined as IMSLN negative. Further IHC detection of CK-9 was required if the IMSLN was HE staining negative to exclude micrometastasis.
- Conditions
- Breast Cancer
- Being tested
- MIT, IM-SLNB
- Keywords
- Breast Cancer, Internal Mammary Lymph Node, Internal Mammary Sentinel Lymph Node Biopsy, Detection Rate
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MITProcedure or surgery
Also called Modified Injection Technique
periareolar intraparenchymal, high volume and ultrasonographic guidance
IM-SLNBProcedure or surgery
Also called Internal Mammary Sentinel Lymph Node Biopsy
IM-SLNB was performed for IMLN visualized patients
| Study group | Role | What they receive |
|---|---|---|
| IM-SLNB with MIT | Experimental | The radiotracer was injected with our modified injection technique (MIT) (periareolar intraparenchymal, high volume and ultrasonographic guidance). Internal mammary sentinel lymph node biopsy (IM-SLNB) was performed for patients with internal mammary visualized. Receives: Procedure: MIT; Procedure: IM-SLNB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visualization Rate
The internal mammary sentinel lymph node visualization rate with our modified injection techniques
Measured: 2 year
Secondary outcomes (4)
Success rate of IM-SLNB
Success rate of IM-SLNB in the IMSLN visualization patients who receive IM-SLNB
Measured: 2 year
Frequency and Severity of Complications with IM-SLNB
IM-SLNB complications in the patients who receive IM-SLNB
Measured: 2 year
Metastasis Rate of IMSLN
Metastasis rate of IMSLN in clinically axillary node-negative and clinically axillary node-positive patients
Measured: 2 year
Clinical Benefits
staging and treatment change rate
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start1 Jul 2018 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Cancer Hospital and Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Hospital of Qingdao University, Henan Cancer Hospital
- Responsible party
- Principal investigator, Yongsheng Wang, Shandong Cancer Hospital and Institute
- Investigators
- Yong-Sheng Yong-Sheng, MD, Study chair, Shandong Cancer Hospital and Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541278
- Sponsor's protocol ID
- PMCT-IMSLNB-MIT
- Status last verified
- May 2018
- First submitted
- 18 May 2018
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Qiu PF, Liu JJ, Liu YB, Yang GR, Sun X, Wang YS. A modified technology could significantly improve the visualization rate of the internal mammary sentinel lymph nodes in breast cancer patients. Breast Cancer Res Treat. 2012 Nov;136(1):319-21. doi: 10.1007/s10549-012-2203-5. Epub 2012 Sep 6. No abstract available.
PubMed 22956005
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Clinical Trial of Internal Mammary Sentinel Lymph Node Biopsy With Modified Injection Technique for Early Breast Cancer
- ClinicalTrials.gov ID
- NCT03541278
- Acronym / sponsor ID
- PMCT-IMSLNB-MIT
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Internal Mammary Lymph Node, Internal Mammary Sentinel Lymph Node Biopsy, Detection Rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Shandong Cancer Hospital and InstituteUniversity, hospital or other
- Collaborators
- The Affiliated Hospital of Qingdao University, Henan Cancer Hospital
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 30 May 2018 (actual)
- 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.
Internal Mammary Lymph Node (IMLN) and Axillary Lymph Node (ALN) are regarded as "the first station" of lymphatic drainage in breast cancer, serving as an important reference for lymph staging and decision-making. Although the concept of Internal Mammary Sentinel Lymph Node Biopsy (IM-SLNB) has been included in the AJCC guidelines since the 6th edition, technical bottlenecks and clinical benefits still remained to be the main reasons limiting its clinical application:
Technical bottlenecks: In previous clinical practice, the internal mammary visualization rate was very low (13% on average, 0% -37%) under the guidance of the traditional radionuclide injection technique, which became a technology bottleneck restricting the widespread of IM-SLNB. After continuous exploration, our center invented the "modified injection technique" of injecting the nuclide tracer into the mammary gland layer at 6 and 12 o'clock around the areolar under the guidance of ultrasound, as well as increasing the injection volume to increase the local tension. A high internal mammary imaging rate of 71% was obtained, which laid a foundation for the further study and clinical application of IM-SLNB.
Clinical benefits: The IM-SLNB is a method to assess IMLN metastatic status in a minimally invasive way, which may improve the system of regional staging and guide precise IMLN treatment. However, based on the current IM-SLNB indication, the internal mammary metastasis rate was only 8%-15%, and it only had little influence on treatment strategy, which led to the controversy of its clinical application. Previous studies of extended radical mastectomy showed that in ALN positive patients the IMLN metastasis rate was 28-52%, while in ALN negative patients the metastasis rate was only 5-17%. Therefore, the continuation of the previous A-SLNB indication (clinical ALN negative) to IM-SLNB is apparently not in line with the current clinical practice, but further evaluation of internal mammary metastasis status in clinical ALN positive patients may receive greater benefit.
This prospective multicenter study attempted to perform IM-SLNB with our modified injection technique both in clinical ALN negative and positive patients for the first time. Through analyzing metastasis rate of IMLN as well as the influences it had on decision making, we hoped to develop more accurate indication for IM-SLNB and guide the individualized precise treatment of IMLN.
Detailed description
Tracer injection and Lymphatic imaging: The radionuclide tracer (99mTc-Sulfur colloid) was prepared by the Nuclear Medicine Department and the sulfur colloid kit (equipped with a filter of 220 nm in diameter to control the size of colloidal particles) was prepared by Beijing Xinkesida company. All patients were injected with 99mTc-Sulfur colloid (1.0~1.2ml/29.6~55.5MBq) in periareolar parenchyma gland under the guidance of ultrasound using the "new injection technique" 3-18h before surgery. SPECT / CT lymphoscintigraphy was performed 30 min before surgery, and the radioactive concentration ("hot spot") near the sternum was defined as IMSLN positive.
IM-SLNB: After modified radical mastectomy / breast-conserving radical surgery, intraoperative γ-detector (Neoprobe 2000, Johnson\& Johnson Company) was used to locate IM-SLN, and intercostal IM-SLNB was performed: open pectoralis major muscle, expose the parasternal intercostal space at the corresponding intercostal level (if the patient underwent breast-conserving surgery and the tumor was located in the lateral quadrant, an additional 3 cm of skin incision was required), cut the intercostal muscle at radioactive concentration site parallel to the rib, search and locate IMSLN with gamma detector, dissect precisely to avoid injury of internal mammary arteries and veins, and then sent the removed tissue to routine pathological examination.
Pathologic diagnosis: IMSLN was divided into 2mm tissue fragments according to the long axis (short diameter < 2 mm, no division), every tissue fragment required one layer of routine HE staining pathological examination. In this study, metastasis > 0.2mm was defined as IMSLN positive, while solitary tumor cell was defined as IMSLN negative. Further IHC detection of CK-9 was required if the IMSLN was HE staining negative to exclude micrometastasis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IM-SLNB with MIT | Experimental | Procedure: MIT, Procedure: IM-SLNBThe radiotracer was injected with our modified injection technique (MIT) (periareolar intraparenchymal, high volume and ultrasonographic guidance). Internal mammary sentinel lymph node biopsy (IM-SLNB) was performed for patients with internal mammary visualized. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with preoperative pathology confirmed invasive breast cancer;
- Clinical T1-3 N0-3 M0 (with positive fine-needle aspiration result in their clinical or ultrasonic suspicious axillary lymph node ; no clinical or radiologic evidence of distant metastases);
- Be able and willing to sign informed consent forms.
Key exclusion criteria (7 listed)
- Patients with enlarged internal mammary nodes by imaging;
- Patients who have received neoadjuvant therapy (including neoadjuvant chemotherapy and / or endocrine therapy);
- Patients with a previous history of breast cancer (recurrence of breast cancer and contralateral breast cancer);
- Patients with a history of other malignancies;
- Patients who have had previous surgery in axillary or internal mammary;
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 |
|---|---|---|
| MITAlso: Modified Injection Techniqueperiareolar intraparenchymal, high volume and ultrasonographic guidance | Procedure or surgery | IM-SLNB with MIT |
| IM-SLNBAlso: Internal Mammary Sentinel Lymph Node BiopsyIM-SLNB was performed for IMLN visualized patients | Procedure or surgery | IM-SLNB with MIT |
Primary outcome
Visualization Rate
Time frame: 2 year
The internal mammary sentinel lymph node visualization rate with our modified injection techniques
4 secondary outcomes
Success rate of IM-SLNB
Time frame: 2 year
Frequency and Severity of Complications with IM-SLNB
Time frame: 2 year
Metastasis Rate of IMSLN
Time frame: 2 year
Clinical Benefits
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Background: PubMed 22956005Qiu PF, Liu JJ, Liu YB, Yang GR, Sun X, Wang YS. A modified technology could significantly improve the visualization rate of the internal mammary sentinel lymph nodes in breast cancer patients. Breast Cancer Res Treat. 2012 Nov;136(1):319-21. doi: 10.1007/s10549-012-2203-5. Epub 2012 Sep 6. No abstract available.
- Individual participant dataSharing planned: Undecided
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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 Yong-Sheng, MD study chair
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 study testing MIT and IM-SLNB 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 3 inclusion and 7 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 30 May 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.
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 Yong-Sheng Wang, MD (+8613505409989, wangysh2008@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visualization Rate (time frame: 2 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 NCT03541278, which also lists 1 linked publication.
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 30 May 2018.