Plain English Summary
Background and study aims
The lymphatic system is made up of a network of thin tubes called lymph vessels and lymph nodes. It is a key part of the body’s immune system, playing an important role in fighting infections and destroying old or abnormal cells (for example, cancer cells). Lymph nodes are found under the armpits, in the groin and also the neck. Breast cancer often spreads to other parts of the body though the lymphatic system., with cancer cells moving out from the tumour in the breast and into the surrounding lymph nodes. This can cause long term damage to the affected lymph node, stopping it from being able to drain properly. The resulting accumulation of fluid (lymph fluid) results in swelling, often of the arm. Knowledge of the upper limb lymphatic system is mainly based on lymphoscintigraphic studies (that is, studies using a imaging technique to look at the lymph nodes and see how well they are draining) performed in patients with breast cancer-related lymphedema (BCRL). While these studies provide information on the how the disease is affecting the body (pathophysiology) in BCRL, they cannot be used in studies interested in the normal functioning of the lymphatic system. The aim of this study is to evaluate, through lymphoscintigraphy, the function of lymphatics in individuals with an intact (normally functioning) lymphatic system.
Who can participate?
Patients suffering from melanoma (a type of skin cancer) and healthy volunteers.
What does the study involve?
Once informed consent has been given by the participants, they undergo a lymphoscintigraphy, which is a scan involving the injection of a small quantity of a radioactive substance called technetium-99m nanocolloid. The injection is made into the skin of the second webspace of each hand (the flashy area between thumb and forefinger) . Patients then lie down so that a gamma camera can be used to take pictures of the upper limbs. This data is then used to look at the functioning of their lymphatic system.
What are the possible benefits and risks of participating?
Patients are exposed to radiation, but at a dose very likely to place them at risk.
Where is the study run from?
University Hospital "P. Giaccone", Department of Surgical, Oncological and Oral Sciences, University of Palermo (Italy)
When is the study starting and how long is it expected to run for?
April 2013 to February 2016
Who is funding the study?
University of Palermo (Italy)
Who is the main contact?
Dr. Matteo Rossi
matt.rossi17@virgilio.it
Trial website
Contact information
Type
Scientific
Primary contact
Dr Matteo Rossi
ORCID ID
http://orcid.org/0000-0002-5265-8299
Contact details
University of Palermo
Department of Surgical
Oncological and Oral Sciences
Plastic and Reconstructive Surgery
Via del Vespro
129
Palermo
90129
Italy
00393334231812
matt.rossi17@virgilio.it
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1/2015
Study information
Scientific title
Evaluation of the upper limb lymphatic system: a prospective lymphoscintigraphic study in melanoma patients and healthy controls
Acronym
Study hypothesis
Current research on the upper limb lymphatic system mainly focuses on breast cancer patients with unilateral lymphedema. In the absence of a preoperative lymphoscintigraphy, the contralateral limb is used as a control, assuming that it is functionally intact. Criteria for lymphatic dysfunction include asymmetric and delayed (>10-30 minutes) transportation time of the radiopharmaceutical. Few lymphoscintigraphic studies have been conducted on patients before any axillary surgical treatment. The aim of this study is to evaluate, through lymphoscintigraphy, the function of lymphatics in individuals with an intact lymphatic system in order to answer the following questions:
1. Is the contralateral “healthy” arm of patients with BCRL be a reliable model to investigate the physiologic lymphatic function?
2. Is there any lymphoscintigraphic pattern that we can consider physiologic or pathologic and predisposing to lymphedema?
3. Is lymphoscintigraphy a reliable test to evaluate the susceptibility to lymphedema?
Ethics approval
University Hospital of Palermo Ethics Committee, 19/01/2016, ref: 1/2015
Study design
Prospective interventional study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Melanoma
Intervention
All subjects from the two groups will undergo lymphoscintigraphy according to the protocol described below:
1. 1 mCi (37 MBq) of 99mTc-labeled nanocolloidal albumin (Nanocoll) in a volume of 0.2 ml simultaneously injected intradermally in the second web space of both hands by two experienced nuclear radiologists
2. With the participant lying supine, gamma camera images of the upper limbs are obtained at 20, 60, and 120 minutes after injection.
In relation to the Time of Appearance of the Tracer (TAT), the lymphatic function of each upper limb are classified into three lymphoscintigraphic patterns: Type I= TAT: 20 minutes; Type II= TAT:60 minutes; type III= TAT: 120 minutes.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Upper limb lymphatic function measured through lymphoscintigraphy and using the Time of Appearance of the Tracer (TAT) to the axillary nodes at 20, 60 and 120 minutes
Secondary outcome measures
N/A
Overall trial start date
01/04/2013
Overall trial end date
29/02/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Study group: melanoma patients:
Inclusion criteria:
1. Recent histological diagnosis of trunk or upper limbs melanoma;
2. No history or clinical findings of lymphedema, venous incompetence or trauma on the upper limbs;
3. Candidates for sentinel lymph node biopsy (SLNB);
4. Age between 18 and 75 y.o.
5. BMI between 20 and 35 kg/m2
Control group: healthy volunteers:
1. Age between 18 and 75 years
2. BMI between 20 and 35 Kg/m2
3. Males and females
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
Study group: 20 patients (40 upper limbs); Control Group: 10 healthy volunteers (20 upper limbs)
Participant exclusion criteria
Study group: melanoma patients:
1. Lung, brain, bones metastasis
2. History or clinical findings of lymphedema, venous incompetence or trauma on the upper limbs.
3. Previous surgery on the upper limbs
4. Allergy to the radiotracer
Control group: healthy volunteers:
1. Pregnancy
2. Allergy to the radiotracer
Recruitment start date
01/05/2013
Recruitment end date
01/06/2015
Locations
Countries of recruitment
Italy
Trial participating centre
University of Palermo
Department of Surgical, Oncological and Oral Sciences
Plastic and Reconstructive Surgery
Via del Vespro, 129
Palermo
90129
Italy
Funders
Funder type
University/education
Funder name
Università degli Studi di Palermo
Alternative name(s)
Palermo University, University of Palermo
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
Italy
Results and Publications
Publication and dissemination plan
Planned publication of a study protocol and results paper in an international peer-reviewed scientific journal
Intention to publish date
30/10/2016
Participant level data
Not expected to be available
Basic results (scientific)
Publication list