AzTrials
AzTrials

Lymphedema of Upper ArmNCT02691624

Study of the Change of Breast Cancer Patients' Upper Limb Lymphatic Drainage Pathway After Operation

An observational study of Lymphedema of Upper Arm, run by Peking University People's Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Lymphoscintigraphy is a noninvasive，accurate and effective imaging modality. In this study, it is used to investigate the imaging characteristics of patients'upper limb lymphatic drainage before operation, and the influence of operation on it. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Lymphedema of Upper Arm
How many people
100 participants
Where
1 siteChina
Study dates
Oct 2015to Dec 2021
Phase
Observational
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 Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: 100 breast cancer patients treated in Peking University People's Hospital Breast Center and agree to receive lymphoscintigraphy of upper extremity.

Who may be able to join

  • For inclusion in the study patients must fulfil all of the following criteria:
  • Diagnosed with breast cancer
  • There is no metastasis except axillary nodes
  • Agree to receive Lymphoscintigraphy of upper extremity

Who cannot join

  • Any of the following is regarded as a criterion for exclusion from the study:
  • Pregnancy or lactation
  • Inflammatory breast cancer
  • Disagree to receive Lymphoscintigraphy of upper extremity
  • History of axillary lymph node resection

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

Other trials in China

About this study

Lymphoscintigraphy is a noninvasive，accurate and effective imaging modality. In this study, it is used to investigate the imaging characteristics of patients'upper limb lymphatic drainage before operation, and the influence of operation on it.

Read the detailed description

The global burden of breast cancer continues to increase largely because of the aging and growth of the world population. More than 1.38 million women worldwide were estimated to be diagnosed with breast cancer in 2008, accounting for 23% of all diagnosed cancers in women. Given that the 5-year survival rate for breast cancer is now 90%, experiencing breast cancer is ultimately about quality of life. Women treated for breast cancer are facing a life-time risk of developing lymphedema, a chronic condition that occurs in up to 40% of this population and negatively affects breast cancer survivors' quality of life. It's becoming more and more important to do more research on the breast cancer-related lymphedema. Axillary reverse mapping (ARM) is a technique used to map arm lymphatic drainage during axillary lymph node dissection (ALND) and/or sentinel lymph node dissection (SLND). It's necessary for the investigators to understand the participants' upper limb lymphatic drainage before operation and what the investigators have done on it during operation. It can be easy to understand the influence of operation on the participants' upper limb lymphatic drainage, the possibility and safety of reserving lymph nodes draining the upper extremity lymph.

Keywords
Lymphedema of Upper Arm, Breast cancer, Breast cancer-related Lymphedema, Lymphoscintigraphy
Medical subject headings
Breast Neoplasms, Breast Cancer Lymphedema

What participants receive

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

Study groups in NCT02691624
Study groupRoleWhat they receive
sentinel lymph node biopsyPatients of the group is diagnosed with breast cancer and receive lymphoscintigraphy before operation, and will receive sentinel lymph node biopsy
axillary lymph node dissectionPatients of the group is diagnosed with breast cancer and receive lymphoscintigraphy before operation, and will receive axillary lymph node dissection

What is being measured

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

  1. Number and relationship with the sentinel lymph node of lymph nodes containing 99mTc-Dextran injected preoperatively to do upper limb lymphoscintigraphy and resected in the process of the sentinel lymph node biopsy

    Patients enrolled undertake upper limb lymphoscintigraphy before sentinel lymph node biopsy(SLNB).The lymph nodes draining upper extremity lymph will contain 99mTc-Dextran and can be detected by γ detector during operation. The number and relationship with the sentinel lymph node can be measured.

    Measured: During operation

  2. Number of lymph nodes containing 99mTc-Dextran injected preoperatively to do upper limb lymphoscintigraphy and resected in the process of the axillary lymph node dissection

    Patients enrolled undertake upper limb lymphoscintigraphy before axillary lymph node dissection(ALND).The lymph nodes draining upper extremity lymph can be detected by γ detector in the tissue resected and axilla after operation. The number of them can be measured.

    Measured: During operation

Secondary outcomes (2)

  1. Pathological result of lymph nodes containing 99mTc-Dextran injected preoperatively to do upper limb lymphoscintigraphy and resected in the process of the sentinel lymph node biopsy

    The pathological result of lymph nodes containing 99mTc-Dextran injected preoperatively to do upper limb lymphoscintigraphy and resected in the process of the sentinel lymph node biopsy will be reported in 5 days after operation

    Measured: in 5 days after operation

  2. Pathological result of lymph nodes containing 99mTc-Dextran injected preoperatively to do upper limb lymphoscintigraphy and resected in the process of the axillary lymph node dissection

    The pathological result of lymph nodes containing 99mTc-Dextran injected preoperatively to do upper limb lymphoscintigraphy and resected in the process of the axillary lymph node dissection will be reported in 5 days after operation

    Measured: in 5 days after operation

Timeline

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

  1. First posted25 Feb 2016 (estimated)
  2. Study startOct 2015
  3. Primary completionMay 2016
  4. Study completionDec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02691624
Sponsor's protocol ID
BCRLResearch001
Status last verified
Dec 2021
First submitted
17 Feb 2016
Last updated
27 Dec 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Fu MR. Breast cancer-related lymphedema: Symptoms, diagnosis, risk reduction, and management. World J Clin Oncol. 2014 Aug 10;5(3):241-7. doi: 10.5306/wjco.v5.i3.241.

    PubMed 25114841

  • Zhu YQ, Xie YH, Liu FH, Guo Q, Shen PP, Tian Y. Systemic analysis on risk factors for breast cancer related lymphedema. Asian Pac J Cancer Prev. 2014;15(16):6535-41. doi: 10.7314/apjcp.2014.15.16.6535.

    PubMed 25169483

  • Suami H, Taylor GI, Pan WR. The lymphatic territories of the upper limb: anatomical study and clinical implications. Plast Reconstr Surg. 2007 May;119(6):1813-1822. doi: 10.1097/01.prs.0000246516.64780.61.

    PubMed 17440362

  • Pavlista D, Eliska O. Analysis of direct oil contrast lymphography of upper limb lymphatics traversing the axilla -- a lesson from the past -- contribution to the concept of axillary reverse mapping. Eur J Surg Oncol. 2012 May;38(5):390-4. doi: 10.1016/j.ejso.2012.01.010. Epub 2012 Feb 14.

    PubMed 22336143

  • Thompson M, Korourian S, Henry-Tillman R, Adkins L, Mumford S, Westbrook KC, Klimberg VS. Axillary reverse mapping (ARM): a new concept to identify and enhance lymphatic preservation. Ann Surg Oncol. 2007 Jun;14(6):1890-5. doi: 10.1245/s10434-007-9412-x. Epub 2007 May 4.

    PubMed 17479341

  • Borri M, Schmidt MA, Gordon KD, Wallace TA, Hughes JC, Scurr ED, Koh DM, Leach MO, Mortimer PS. Quantitative Contrast-Enhanced Magnetic Resonance Lymphangiography of the Upper Limbs in Breast Cancer Related Lymphedema: An Exploratory Study. Lymphat Res Biol. 2015 Jun;13(2):100-6. doi: 10.1089/lrb.2014.0039. Epub 2015 Mar 16.

    PubMed 25774851

  • Liu NF, Lu Q, Liu PA, Yan ZX, Wu XF. [Comparison study of radionuclide lymphoscintigraphy and dynamic magnetic resonance lymphangiography for the diagnosis of extremity lymphedema]. Zhonghua Zheng Xing Wai Ke Za Zhi. 2011 Jul;27(4):241-5. Chinese.

    PubMed 22097305

  • Liu NF, Lu Q, Liu PA, Wu XF, Wang BS. Comparison of radionuclide lymphoscintigraphy and dynamic magnetic resonance lymphangiography for investigating extremity lymphoedema. Br J Surg. 2010 Mar;97(3):359-65. doi: 10.1002/bjs.6893.

    PubMed 20101589

  • Norman SA, Localio AR, Potashnik SL, Simoes Torpey HA, Kallan MJ, Weber AL, Miller LT, Demichele A, Solin LJ. Lymphedema in breast cancer survivors: incidence, degree, time course, treatment, and symptoms. J Clin Oncol. 2009 Jan 20;27(3):390-7. doi: 10.1200/JCO.2008.17.9291. Epub 2008 Dec 8.

    PubMed 19064976

  • International Society of Lymphology. The diagnosis and treatment of peripheral lymphedema: 2013 Consensus Document of the International Society of Lymphology. Lymphology. 2013 Mar;46(1):1-11.

    PubMed 23930436

  • Liu S, Wang N, Gao P, Liu P, Yang H, Xie F, Wang S, Liu M, Wang S. Using the axillary reverse mapping technique to screen breast cancer patients with a high risk of lymphedema. World J Surg Oncol. 2020 Jun 1;18(1):118. doi: 10.1186/s12957-020-01886-9.

    PubMed 32482174

Questions about this trial

What is this clinical trial studying?

An observational study of Lymphedema of Upper Arm, run by Peking University People's Hospital 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 4 inclusion and 5 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 27 Dec 2021. 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?

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 and relationship with the sentinel lymph node of lymph nodes containing 99mTc-Dextran injected preoperatively to do upper limb lymphoscintigraphy and resected in the process of the sentinel lymph node biopsy (time frame: During operation). The study lists 2 primary outcomes in all. 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 NCT02691624, which also lists 11 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 27 Dec 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in