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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs031200114

Enrollment

Registered

2020-09-10

Start date

2020-11-17

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

cervical cancer, corpus cancer, ovarian cancer

Interventions

The subjects are administered the Indocyanine Green subcutaneously at pre-operation,1,3 and 9 months after operation.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion 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 2.8g/dl 6. Serum creatinine < 1.5 times lower than the normal range

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Safety evaluation of subcutaneous ICG injection (Adverse events, vital signs and physical findings)	—

Secondary

Measure	Time frame
1.To investigate the relationship between lymphedema development at 9 months postoperatively and lymphatic function (lymphatic transport velocity and presence of dermal backflow) as well as lymphatic morphology (vessel diameter, number of lymph duct, and presence of collateral pathways) 2. The comparison of lymph duct morphology and function between pre-surgery and 1.3,9 month after surgery 3. The relationship between the rate of lymphedema and the lymph duct morphology and function at 1.3 and 9 month after surgery 4. The morphological and functional changes after surgery (1.3 and 9 months), compared to the pre-operative condition 5. The relationship between the pre-operative background and the rate of lymphedema at 1.3 and 9 month after surgery 6. The relationship between the operative findings and the rate of lymphedema at 1.3 and 9 month after surgery	—

Measure

Time frame

1.To investigate the relationship between lymphedema development at 9 months postoperatively and lymphatic function (lymphatic transport velocity and presence of dermal backflow) as well as lymphatic morphology (vessel diameter, number of lymph duct, and presence of collateral pathways) 2. The comparison of lymph duct morphology and function between pre-surgery and 1.3,9 month after surgery 3. The relationship between the rate of lymphedema and the lymph duct morphology and function at 1.3 and 9 month after surgery 4. The morphological and functional changes after surgery (1.3 and 9 months), compared to the pre-operative condition 5. The relationship between the pre-operative background and the rate of lymphedema at 1.3 and 9 month after surgery 6. The relationship between the operative findings and the rate of lymphedema at 1.3 and 9 month after surgery

—

Contacts

Public ContactTakashi Hirayama

Juntendo University Hospital

thiraya@juntendo.ac.jp+81-3-3813-3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026