Evaluation of the upper limb lymphatic system

Completed

• Conditions: Melanoma; Cancer; Malignant melanoma of skin

• Registration Number: ISRCTN12987051
• Lead Sponsor: niversity of Palermo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-11
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Study group: melanoma patients:

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pper 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