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LymphadenectomyNCT02415725

Early Detection of Lymphedema After Cancer Treatments

A study testing Indocyanine Green in people with Lymphadenectomy and Breast Cancer, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Many clinical situations in oncologic surgery imply the need to dissect more or less extensively lymph node stations which are in direct relation with the lymphatic drainage of the anatomical region affected by cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphadenectomy, Breast Cancer
What is being tested?
Indocyanine Green
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteBelgium
Study dates
Sep 2014to Jan 2018
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who will undergo lymphadenectomy (either large lymphadenectomy or sentinel lymph node biopsy) for oncologic reason (gynaecologic, urologic or mammary cancer, melanoma and other skin cancer) without measurable or observable limb lymphedema.
  • Informed consent form signed.

Who cannot join

  • Allergy to iodine.
  • Incapaciy to give informed consent.
  • < 18 years.
  • Pregnancy or breastfeeding.
  • Coronary disease.
  • Advanced renal impairment.
  • Hyperthyroidism.

Trial locations and contacts

1 site in 1 country.

Belgium1 site, 1 recruiting
  • CHU St-Pierre - Clinique de Lymphologie

    Brussels, 1000

    Liesbeth Vandermeeren, MD, 00322535 ext. 3762, liesbethvandermeeren@hotmail.com

    Liesbeth Vandermeeren, MD

    Recruiting

Other trials in Belgium

About this study

Official title: Early Detection of Secondary Lymphedema After Cancer Treatments

Many clinical situations in oncologic surgery imply the need to dissect more or less extensively lymph node stations which are in direct relation with the lymphatic drainage of the anatomical region affected by cancer.

The dissected lymph nodes drain generally several regions, and their dissection reduces then the drainage capacity of all these regions, increasing the risk for the patient to develop a secondary lymphedema, shorter or longer after surgery.

Read more

Efficient treatments exist, but are difficult to implement and to continue for a long time.The later the treatment of the lymphedema begins, the heavier it is, both on the medical and socio-economic level.

The lymphofluoroscopy, shows that some oncologic patients, operated and free of apparent secondary lymphedema, present abnormalities of the lymphatic network.

The present study aims to confirm that it is now possible to detect secondary lymphedema at a subclinical stage.

Read the detailed description

Many clinical situations in oncologic surgery imply the need to dissect more or less extensively lymph node stations which are in direct relation with the lymphatic drainage of the anatomical region affected by cancer.

The dissected lymph nodes drain generally several regions, and their dissection reduces then the drainage capacity of all these regions, increasing the risk for the patient to develop a secondary lymphedema, shorter or longer after surgery.

The recent meta-analysis show that nearly 15% of patient operated for a cancer with lymph node dissection develop after 27 months from surgery a lymphedema of the limb corresponding to the operated region.

Radio- and chemotherapy may especially encumber the already reduced lymphatic capacity.

The impact on the health and the quality of life of the patient is very significant on the physical and psychological aspect, but also on social and economic aspect.

Efficient treatments exist, but are difficult to implement and to continue for a long time. They are considered as serious diseases which are expensive for the INAMI. Lymphedema is a chronic disease which needs repeated and continued treatments. The later the treatment of the lymphedema begins, the heavier it is, both on the medical and socio-economic level. Some patients even lose their job because of their functional infirmity.

Here the investigators remind that lymphedema is painless, even in its most spectacular cases.

Still currently, a lymphedema is diagnosed after it has developed, and only when the functional discomfort, or the physical appearance disturb the patient enough to go to consultation.

The lymphofluoroscopy (new emerging imaging technique in the field of lymphology) used since 3 years by the promoters of the present project, shows that some oncologic patients, operated and free of apparent secondary lymphedema, present abnormalities of the lymphatic network. These patients report heaviness sensations or sporadic paraesthesia which generally does not arouse suspicion of beginning lymphedema.

The present prospective, multidisciplinary and multicentric clinical study aims to confirm that it is now possible to detect secondary lymphedema at a subclinical stage. In a second step, prevention will be considered. Detection may be performed using a simple lymphofluoroscopic examination, which is a minimally invasive and inexpensive imaging technique. It allows to realize a mapping of the superficial lymphatic network and to identify the characteristics of the secondary lymphedema in the group of patients at risk to develop lymphedema after lymph node dissection.

Being tested
Indocyanine Green
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Indocyanine GreenDrug

    Also called ICG

    visualization of the architecture of superficial lymphatic network after Indocyanine Green injection

Study groups in NCT02415725
Study groupRoleWhat they receive
lymphofluoroscopyExperimentalIndocyanine Green intradermal injection before surgery, and after 3, 6 and 12 monthes
Receives: Drug: Indocyanine Green

What is being measured

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

  1. number of lymphatic vessels visualized

    Measured: 12 monthes

Timeline

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

  1. First posted14 Apr 2015 (estimated)
  2. Study startSep 2014
  3. Primary completionDec 2017 (estimated)
  4. Study completionJan 2018 (estimated)

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 N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02415725
Sponsor's protocol ID
2LEED-ICG
Status last verified
Mar 2015
First submitted
27 Mar 2015
Last updated
14 Apr 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Indocyanine Green in people with Lymphadenectomy and Breast Cancer, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.

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 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 14 Apr 2015. 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 Belgium. 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 Liesbeth Vandermeeren, MD (00322535 ext. 3762, liesbethvandermeeren@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

number of lymphatic vessels visualized (time frame: 12 monthes). 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 14 Apr 2015.

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