The safety and efficacy of gadobutrol MR lymphography

Phase 2

Recruiting

• Conditions: lymphedema

• Registration Number: JPRN-jRCTs041220015
• Lead Sponsor: Yasunaga Yoshichika

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-02
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

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

Inclusion Criteria

(1) Patients with a diagnosis of secondary lymphedema of the lower or upper extremities who are scheduled for surgery.
(2) The planned procedure is lymphaticovenular anastomosis (LVA).
(3) International Society of Lymphology (ISL) stage II (early stage II, late stage II)
(4) Patients whose written consent has been obtained prior to enrollment
(5) Age: 20 years or older
(6) Performance Status (PS) Score: 0 or 1 according to Eastern Cooperative Oncology Group (ECOG) criteria

Exclusion Criteria

(1) Patients with contraindications to MRI imaging (non-MRI-compatible metals, body metals not confirmed as 3T MRI-compatible in the product document, claustrophobia)
(2) History of allergy to gadolinium-based contrastagent
(3) Patients undergoing treatment for bronchial asthma
(4) Patients with renal dysfunction (eGFR < 30mL/min/1.73m2)
(5) Others: Patients who, in the judgment of the physician, are considered to be inappropriate for this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of adverse events with gadobutrol MRL (pain during subcutaneous injection of gadobutrol,anaphylactic reaction for 7 days after the test, and skin disorder for 7 days after the test)

Secondary Outcome Measures

Name	Time	Method
(1) Height of the contrast reach point of gadobutrol MRL<br>(2) Depth of gadbutrol MRL-detected lymphatic vessels anastomosed in LVA surgery<br>(3) Thickness of gadbutrol MRL-detected lymphatic vessels anastomosed in LVA surgery<br>(4) Water volume reduction in the affected limb at1 year postoperatively<br>(5) Edema reduction rate at 1 year postoperatively(unilateral cases only)<br>(6) Number of cellulitis incidents in the affected limb during the first year postoperatively