A pilot study to assess the safety of the ICG angiography for the evaluation of lymph duct morphology and function before and after pelvic lymphadenectomy in patients with gynecologic cancers.

JRCT ID: jRCTs031200114

Registered date:10/09/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: cervical cancer, corpus cancer, ovarian cancer
• Date of first enrollment: 10/09/2020
• Target sample size: 30
• Study type: Interventional
• Intervention(s): The subjects are administered the Indocyanine Green subcutaneously at pre-operation,1,3 and 9 months after operation.

Outcome(s)

• Primary Outcome: Safety evaluation of subcutaneous ICG injection (Adverse events, vital signs, clinical examination and clinical symptoms)

Secondary Outcome

1. The comparison of lymph duct morphology and function between pre-surgery and 1.3,9 month after surgery
2. The relationship between the rate of lymphedema and the lymph duct morphology and function at 1.3 and 9 month after surgery
3. The morphological and functional changes after surgery (1.3 and 9 months), compared to the pre-operative condition
4. The relationship between the pre-operative background and the rate of lymphedema at 1.3 and 9 month after surgery
5. The relationship between the operative findings and the rate of lymphedema at 1.3 and 9 month after surgery

Key inclusion & exclusion criteria

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

Include criteria

1) Age>20 years old, Sex: female
2) Cervical cancer or Corpus cancer or Ovarian cancer
3) Pelvic lymphadenectomy is scheduled.
4) Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2
5) Written informed consent
6) Adequate organ function (especially in bone marrow, liver and kidney): Meet the criteria as below within 14 days before registration.
1. WBC >= 3000 /mm3 and Neutrophil > 1500mm3
2. Platelet > 100,000/ mm3
3. AST, ALT < 2.5 times lower than the normal range
4. Total bilirubin < 1.5 times lower than the normal range
5. Serum albumin > 2.8g/dl
6. Serum creatinine < 1.5 times lower than the normal range

Exclude criteria

1)History of radiation therapy
2)History of chemotherapy
3)Allergy to ICG
4)Allergy to iodine
5)Others who are not suitable for this research

Related Information

• Primary Sponsor: Hirayama Takashi
• Source(s) of Monetary Support: Japan Society for the Promotion of Science