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.
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
- Recruiting
CHU St-Pierre - Clinique de Lymphologie
Brussels, 1000
Liesbeth Vandermeeren, MD, 00322535 ext. 3762, liesbethvandermeeren@hotmail.com
Liesbeth Vandermeeren, MD
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.
- Conditions
- Lymphadenectomy, Breast Cancer
- 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 group | Role | What they receive |
|---|---|---|
| lymphofluoroscopy | Experimental | Indocyanine 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.
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.
- First posted14 Apr 2015 (estimated)
- Study startSep 2014
- Primary completionDec 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphadenectomyStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liesbeth Vandermeeren, MD, Principal investigator, CHU St-Pierre
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Secondary Lymphedema After Cancer Treatments
- ClinicalTrials.gov ID
- NCT02415725
- Acronym / sponsor ID
- 2LEED-ICG
- Conditions
- Lymphadenectomy, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 14 Apr 2015 (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.
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.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lymphofluoroscopy | Experimental | Drug: Indocyanine GreenIndocyanine Green intradermal injection before surgery, and after 3, 6 and 12 monthes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- Allergy to iodine.
- Incapaciy to give informed consent.
- < 18 years.
- Pregnancy or breastfeeding.
- Coronary disease.
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 |
|---|---|---|
| Indocyanine GreenAlso: ICGvisualization of the architecture of superficial lymphatic network after Indocyanine Green injection | Drug | lymphofluoroscopy |
Primary outcome
number of lymphatic vessels visualized
Time frame: 12 monthes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
Related trials for Lymphadenectomy
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
Not yet recruiting
Comparison of Serratus Posterior Superior Intercostal Plane Block and Rhomboid Intercostal Block in Patients Undergoing Breast Cancer Surgery
Breast Cancer, Lymph Node Dissection
Not yet recruitingPhase 2
D2 Gastrectomy With or Without Para-Aortic Lymph Node Dissection After Chemoimmunotherapy for Gastric Cancer
Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
Not yet recruiting
Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
Breast Neoplasm Malignant Primary, Lymphedema Arm
Not yet recruitingObservational study
Lymph Node Dissection After Neoadjuvant Therapy for Gastric and EGJ Adenocarcinoma
Gastric Adenocarcinoma, Esophagogastric Junction Adenocarcinoma
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.
Liesbeth Vandermeeren, MD principal investigator
CHU St-Pierre
1 site in 1 country: see every site and its status.
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.