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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000024636
Enrollment
90
Registered
2016-11-01
Start date
2016-11-10
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 Endometrial cancer

Interventions

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 ce
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

Sponsors

Ciba University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Patients with endometrial cancer who are scheduled for retroperitoneal lymph node dissection or 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 provides written informed consent

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Detection rate of SLN

Secondary

MeasureTime frame
Sensitivity, false negative rate, and negative predictive value of SLN Accuracy of pathological diagnosis during surgery Adverse effects The number and location of the SLNs

Countries

Japan

Contacts

Public ContactAkira Mitsuhashi

Graduate School of Medicine, Chiba University Reproductive Medicine

antira@faculty.chiba-u.jp043-222-7171

Outcome results

None listed

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