Indocyanine green and infrared fluorescence in sentinel lymph node mapping for endometrial cancer and cervical cancer: An exploratory study

JRCT ID: jRCTs031180426

Registered date:25/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Endometria cancer, Cervical cancer
• Date of first enrollment: 08/11/2016
• Target sample size: 90
• Study type: Interventional
• Intervention(s): The concentration of indocyanine green (ICG) is 2.5 mg/mL. For each patient, a 25 mg vial with ICG powder is diluted in 10 mL of sterile water. We routinely inject 4 mL of the ICG solution into the cervix divided in the 3 - and 9-o'clock positions, 1 mL deep into the stroma and 1 mL submucosally on the right and the left of the cervix. Additionally, in patients with endometrial cancer, 2 mL of ICG is injected into the myometrium divided into the lower uterine segment and uterine fundus (midline subserosa). A near-infrared fluorescence imaging system Photodynamic Eye (PDE - Neo, Hamamatsu Photonics, Hamamatsu, Japan) is used to detect the SNLs.

Outcome(s)

• Primary Outcome: The detection rate of SLN

Secondary Outcome

1.The sensitivity of sentinel lymph node (SLN)
2 A false negative rate of SLN
3. Negative predictive value of SLN
4. The accuracy of pathological diagnosis during surgery
5. The number and location of the SLNs
6. Adverse effects

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 70age old
• Gender: Female

Include criteria

1. Patients with endometrial cancer who are scheduled for retroperitoneal lymph node dissection or patients with stage 1A2 to 2A1 cervical cancer based on the International Federation of Gynecology and Obstetrics guidelines.
2. Over 20 years of age and under 70 years of age
3. Eastern Cooperative Oncology Group Performance status score 0-1
4. Patients who provide written informed consent

Exclude criteria

1.Prior medical history of chemical sensitivity to indocyanine green
2.Detection of obvious lymph node swelling using CT or MRI
3.Extra-uterine dissemination
4.Patients on dialysis
5.Patients determine to be ineligible for any other reason by the physician in-charge

Related Information

• Primary Sponsor: Usui Hirokazu
• Secondary ID(s): UMIN000024636