Condition category
Cancer
Date applied
01/03/2016
Date assigned
11/03/2016
Last edited
11/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

University of Palermo

Sponsor details

Department of Surgical
Oncological and Oral Sciences
via del vespro
129
Palermo
90129
Italy

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Università degli Studi di Palermo

Alternative name(s)

University of Palermo, Palermo University

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes