The safety and efficacy of gadobutrol MR lymphography

JRCT ID: jRCTs041220015

Registered date:02/05/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: lymphedema
• Date of first enrollment: 06/06/2022
• Target sample size: 30
• Study type: Interventional

Intervention(s)

As a preoperative test for lymphaticovenular anastomosis (LVA), MR lymphangiography (MRL) is performed using gadobutrol as a contrast agent to measure the location of the contrast reach point and the location, depth, and thickness of the lymphatic vessels to be anastomosed.
At the time of LVA operation, indocyanine green (ICG) lymphography is performed as a conventionalmethod to measure the contrast reach point and compare it with MRL.
In addition, pain during subcutaneous injection of gadobutrol and the presence of anaphylactic reaction for 7 days after the test and skin disorder atthe injection site for 7 days after the test will be evaluated.

Outcome(s)

• Primary Outcome: 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

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Yasunaga Yoshichika