Prospective ultrasound based study of lymphatic vessels using ultrasound contrast agent

Phase 1

• Conditions: MedDRA version: 20.0Level: LLTClassification code 10025233Term: LymphedemaSystem Organ Class: 100000004866; MedDRA version: 20.0Level: LLTClassification code 10054561Term: Post-mastectomy lymphedema syndromeSystem Organ Class: 100000004863; MedDRA version: 20.0Level: LLTClassification code 10036389Term: Postmastectomy lymphedema syndromeSystem Organ Class: 100000004863; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2018-004389-33-FI
• Lead Sponsor: Olli Lahtinen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-20
• Last Update Posted: 13 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1st branch: 50 healthy volunteers with no prior upper arm surgery
2nd branch: 50 consecutive patients with known history of breast cancer or upper arm melanoma with possible known lymphedema.
3rd branch: 30 patients with prior history of breast cancer and possible lymphedema. All consecutive breast cancer patients having traditional lymphoscintigraphy as a part of their standard imaging are also recruited for this branch.
4th branch: 30 consecutive patients with newly diagnosed vulvar cancer to whom sentinel biopsy will be scheduled.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

1) Vulvar carcinoma patients who won’t have traditional lymphoscintigraphy (branch 4) 2) Vulvar carcinoma patients with prior lymphadenectomy in the groin area (branch 4) 3) People with egg allergy (all branches) 4) Patients to whom gadolinium contrast agent is contraindicated (branch 3) 5) Patients who have claustrophobia and can’t enter the MRI (branch 3). 6) Patients who have foreign material in their body which is contraindicated for MRI

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the feasibility of the contrast enhanced ultrasound (CEUS) imaging in lymphatic vessels and to evaluate the rate of finding lymphedema and compare CEUS with other imaging modalities.;Secondary Objective: No;Primary end point(s):