Prospective ultrasound based study of lymphatic vessels using ultrasound contrast agent

Contrast enhanced ultrasound a novel technique in lymphatic imaging – A Prospective study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-004389-33-FI

Enrollment

160

Registered

2020-05-20

Start date

2020-07-10

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MedDRA version: 20.0 Level: LLT Classification code 10025233 Term: Lymphedema System Organ Class: 100000004866 MedDRA version: 20.0 Level: LLT Classification code 10054561 Term: Post-mastectomy lymphedema syndrome System Organ Class: 100000004863 MedDRA version: 20.0 Level: LLT Classification code 10036389 Term: Postmastectomy lymphedema syndrome System Organ Class: 100000004863

Interventions

Trade Name: Sonazoid Pharmaceutical Form: Powder for suspension for injection INN or Proposed INN: PERFLUBUTANE CAS Number: 355-25-9

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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):	—

Countries

Finland

Contacts

Public ContactKuopio University Hospital

Olli Lahtinen

olli.lahtinen@kuh.fi

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026