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Early Detection of Lymphedema After Cancer Treatments

Primary Purpose

Lymphadenectomy, Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Indocyanine Green
Sponsored by
Centre Hospitalier Universitaire Saint Pierre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lymphadenectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU St-Pierre - Clinique de LymphologieRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

lymphofluoroscopy

Arm Description

Indocyanine Green intradermal injection before surgery, and after 3, 6 and 12 monthes

Outcomes

Primary Outcome Measures

number of lymphatic vessels visualized

Secondary Outcome Measures

Full Information

First Posted
March 27, 2015
Last Updated
April 9, 2015
Sponsor
Centre Hospitalier Universitaire Saint Pierre
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1. Study Identification

Unique Protocol Identification Number
NCT02415725
Brief Title
Early Detection of Lymphedema After Cancer Treatments
Official Title
Early Detection of Secondary Lymphedema After Cancer Treatments
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Saint Pierre

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphadenectomy, Breast Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
lymphofluoroscopy
Arm Type
Experimental
Arm Description
Indocyanine Green intradermal injection before surgery, and after 3, 6 and 12 monthes
Intervention Type
Drug
Intervention Name(s)
Indocyanine Green
Other Intervention Name(s)
ICG
Intervention Description
visualization of the architecture of superficial lymphatic network after Indocyanine Green injection
Primary Outcome Measure Information:
Title
number of lymphatic vessels visualized
Time Frame
12 monthes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liesbeth Vandermeeren, MD
Phone
00322535
Ext
3762
Email
liesbethvandermeeren@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liesbeth Vandermeeren, MD
Organizational Affiliation
CHU St-Pierre
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU St-Pierre - Clinique de Lymphologie
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liesbeth Vandermeeren, MD
Phone
00322535
Ext
3762
Email
liesbethvandermeeren@hotmail.com
First Name & Middle Initial & Last Name & Degree
Liesbeth Vandermeeren, MD

12. IPD Sharing Statement

Learn more about this trial

Early Detection of Lymphedema After Cancer Treatments

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