Early Detection of Lymphedema After Cancer Treatments

NCT02415725 | Unknown

• 1 other identifier: 2LEED-ICG
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphadenectomy; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• number of lymphatic vessels visualized

  12 monthes

Study Arms (1)

lymphofluoroscopy

EXPERIMENTAL

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

Drug: Indocyanine Green

Interventions

Indocyanine Green DRUG

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

Also known as: ICG

lymphofluoroscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead

Study Sites (1)

CHU St-Pierre - Clinique de Lymphologie

Brussels, 1000, Belgium

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Liesbeth Vandermeeren, MD

  CHU St-Pierre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liesbeth Vandermeeren, MD

CONTACT

00322535; liesbethvandermeeren@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2015
• First Posted: April 14, 2015
• Study Start: September 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: April 14, 2015

Record last verified: 2015-03

Locations

BE (1)