- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02415725
Early Detection of Lymphedema After Cancer Treatments
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Liesbeth Vandermeeren, MD
- Phone Number: 3762 00322535
- Email: liesbethvandermeeren@hotmail.com
Study Locations
-
-
-
Brussels, Belgium, 1000
- Recruiting
- CHU St-Pierre - Clinique de Lymphologie
-
Contact:
- Liesbeth Vandermeeren, MD
- Phone Number: 3762 00322535
- Email: liesbethvandermeeren@hotmail.com
-
Principal Investigator:
- Liesbeth Vandermeeren, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Allergy to iodine.
- Incapaciy to give informed consent.
- < 18 years.
- Pregnancy or breastfeeding.
- Coronary disease.
- Advanced renal impairment.
- Hyperthyroidism.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: lymphofluoroscopy
Indocyanine Green intradermal injection before surgery, and after 3, 6 and 12 monthes
|
visualization of the architecture of superficial lymphatic network after Indocyanine Green injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
number of lymphatic vessels visualized
Time Frame: 12 monthes
|
12 monthes
|
Collaborators and Investigators
Investigators
- Principal Investigator: Liesbeth Vandermeeren, MD, CHU ST-Pierre
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2LEED-ICG
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
Baylor Breast Care CenterRecruitingBreast Cancer | Breast Neoplasm | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Stage II | Breast Cancer Female | Breast Cancer Stage III | Estrogen Receptor-positive Breast Cancer | Hormone Receptor-positive Breast Cancer | Breast Cancer InvasiveUnited States
-
Innocrin PharmaceuticalCompletedBreast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the BreastUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)WithdrawnStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer
Clinical Trials on Indocyanine Green
-
University of PennsylvaniaCompletedIschemic Stroke | Traumatic Brain Injury | Subarachnoid Hemorrhage | Intracerebral Hemorrhage | Acute Anoxic EncephalopathyUnited States
-
Corporacion Parc TauliRecruitingAcute Cholecystitis | Bile Duct InjurySpain
-
Wei ChenEnrolling by invitation
-
Shanghai University of Traditional Chinese MedicineUnknownRheumatoid Arthritis | Lymph Node Mass | Lymphatic Vessel; DilatationChina
-
Birmingham Women's and Children's NHS Foundation...Not yet recruitingTracheo-Esophageal Fistula With Atresia of EsophagusUnited Kingdom
-
Bakirkoy Dr. Sadi Konuk Research and Training HospitalRecruitingSentinel Lymph NodeTurkey
-
NYU Langone HealthRecruitingRotator Cuff TearsUnited States
-
Rigshospitalet, DenmarkActive, not recruitingGastric CancerDenmark
-
Mayo ClinicWithdrawnGastric CancerUnited States
-
Institut de Cancérologie de LorraineCompleted