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AzTrials

Breast CancerPhase 2IMSLNB-EBCPNCT01642511

Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Negative

A Phase 2 study testing 99mTc-labeled Sulfur Colloid, Axillary Sentinel Lymph Node Biopsy and Methylthioninium in people with Breast Cancer, run by Shandong Cancer Hospital and Institute at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In addition to the axillary lymph node, the internal mammary lymph node (IMLN) chain is also the first-echelon nodal drainage site for metastasis and provides important prognostic information in breast cancer patients. Read more about this study

Who is it for?
Ages 18 to 80 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
99mTc-labeled Sulfur Colloid, Axillary Sentinel Lymph Node Biopsy and Methylthioninium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
407 participants
Where
1 siteChina
Study dates
Jan 2012to Mar 2015
Phase
Phase 2
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 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • primary breast cancer
  • clinically axilla-negative

Who cannot join

  • enlarged internal mammary nodes by imaging

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

Other trials in China

About this study

Official title: Phase II Trail of Internal Mammary Sentinel Lymph Node Biopsy in Early Breast Cancer Patients With Clinically Axillary Node -Negative

In addition to the axillary lymph node, the internal mammary lymph node (IMLN) chain is also the first-echelon nodal drainage site for metastasis and provides important prognostic information in breast cancer patients. The internal mammary sentinel lymph node biopsy (IM-SLNB) provides a less invasive method of assessing the IMLN than surgical dissection. But the low visualization rate of IMSLN has been a restriction of IM-SLNB. This clinical trial is carried out to improve the visualization rate of IMSLN with modified techniques: (1) The radiotracer is injected intraparenchymally into 2~4 quadrants of breast. (2) The radiotracer is injected in a high volume. (3) The radiotracer should be injected under ultrasonographic guidance.

Read the detailed description

OBJECTIVES:

  • Compare the visualization rate of internal mammary sentinel lymph node in breast cancer patients with different injection technologies.
  • Evaluate the metastasis rate of internal mammary sentinel lymph nodes in patients with clinically axillary node -negative in these patients.
  • Evaluate the risk factors for internal mammary sentinel lymph node metastasis
  • Evaluate the success rate and the safety of internal mammary sentinel lymph node biopsy.
  • Draw the learning curve of internal mammary sentinel lymph node biopsy.

OUTLINE:

3~18 hours before surgery, 99mTc-labeled sulfur colloid was injected under ultrasonographic guidance in different patterns and injection methods were classified according to the number of injection quadrants. Subsequently, lymphoscintigraphy was performed 0.5~1.0 hour before surgery. During surgery, the sentinel lymph nodes (axillary or internal mammary) were identified by combining the use of intraoperative gamma detector and blue dye. The sentinel lymph nodes (axillary or internal mammary) were analyzed by hematoxylin-eosin staining and immunohistochemistry for future therapy planning.

Conditions
Breast Cancer
Being tested
99mTc-labeled Sulfur Colloid, Axillary Sentinel Lymph Node Biopsy, Methylthioninium, Lymphoscintigraphy, Axillary Lymph Node Dissection
Keywords
Breast Cancer, Sentinel Lymph Node Biopsy, Internal Mammary, Lymphoscintigraphy
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 99mTc-labeled Sulfur ColloidRadiation

    Also called 99mTc-SC

    Control Group: Each patient received the 1 intraparenchymal injection of 99mTc-SC (0.5~1.0 mCi/0.5mL) in the tumor quadrant. Study Group: 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.

  • Axillary Sentinel Lymph Node BiopsyProcedure or surgery

    Also called SLNB

    Sentinel lymph node biopsy

  • MethylthioniniumDrug

    Four milliliters of methylthioninium was injected subcutaneously above the primary tumor or around the biopsy cavity 10 min before surgery

  • LymphoscintigraphyDevice

    Also called LSG

    Sequential anterior and lateral gamma imaging was performed with patients lying prone and by injection side just before surgery using a digital gamma camera computer system (Toshiba GCA-901A/HG).

  • Axillary Lymph Node DissectionProcedure or surgery

    Also called ALND

    ALND was performed consequently if axillary SLNB was failure or axillary SLNs were positive.

  • Internal Mammary Sentinel Lymph Node BiopsyProcedure or surgery

    Also called IM-SLNB

    Internal mammary sentinel lymph node biopsy

Study groups in NCT01642511
Study groupRoleWhat they receive
Control GroupActive comparatorconventional technique: 99mTc-labeled Sulfur Colloid was injected into the tumor quadrant 3-24 hours before surgery, lymphoscintigraphy was performed 30min before surgery. Four milliliters of methylthioninium was injected subcutaneously above the primary tumor or around the biopsy cavity 10 min before surgery. Axillary sentinel lymph node biopsy and Internal mammary sentinel lymph node biopsy was performed during surgery. Axillary lymph node dissection was performed if ASLN was positive.
Receives: Radiation: 99mTc-labeled Sulfur Colloid; Procedure: Axillary Sentinel Lymph Node Biopsy; Drug: Methylthioninium; Device: Lymphoscintigraphy; Procedure: Axillary Lymph Node Dissection; Procedure: Internal Mammary Sentinel Lymph Node Biopsy
Study GroupExperimentalmodified technique: 99mTc-labeled Sulfur Colloid was injected into 2 quadrants of the breast 3-24 hours before surgery, lymphoscintigraphy was performed 30min before surgery. Four milliliters of methylthioninium was injected subcutaneously above the primary tumor or around the biopsy cavity 10 min before surgery. Axillary sentinel lymph node biopsy and Internal mammary sentinel lymph node biopsy was performed during surgery. Axillary lymph node dissection was performed if ASLN was positive.
Receives: Procedure: Axillary Sentinel Lymph Node Biopsy; Drug: Methylthioninium; Device: Lymphoscintigraphy; Procedure: Axillary Lymph Node Dissection; Procedure: Internal Mammary Sentinel Lymph Node Biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visualization rate of IMSLN

    Visualization rate of IMSLN between conventional and modified techniques

    Measured: 1 year

Secondary outcomes (3)

  1. Metastasis Rate of IMSLN

    Metastasis rate of IMSLN in clinically axillary node-negative patients with IM-SLNB

    Measured: 15 months

  2. Frequency and Severity of Complications with IM-SLNB

    IM-SLNB complications in the patients who receive IM-SLNB

    Measured: 1 year

  3. Success rate of IM-SLNB

    Success rate of IM-SLNB in the IMSLN visualization patients who receive IM-SLNB

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionNov 2014
  4. Study completionMar 2015

Resources

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 2
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
407 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01642511
Sponsor's protocol ID
IMSN001
Acronym
IMSLNB-EBCP
Status last verified
Apr 2018
First submitted
11 Jul 2012
Last updated
4 Apr 2018
Results posted
No
Data monitoring committee
No

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

  • Qiu P, Zhao R, Cong B, Yang G, Liu Y, Chen P, Sun X, Wang C, Wang Y. [Internal mammary sentinel lymph node biopsy in breast cancer: accurate staging and individualized treatment]. Zhonghua Zhong Liu Za Zhi. 2016 Jan;38(1):42-7. doi: 10.3760/cma.j.issn.0253-3766.2016.01.009. Chinese.

    PubMed 26796806

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 99mTc-labeled Sulfur Colloid, Axillary Sentinel Lymph Node Biopsy and Methylthioninium 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 4 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Visualization rate of IMSLN (time frame: 1 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 NCT01642511, which also lists 2 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 4 Apr 2018.

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