Evaluation of Sentinel Lymph Node Biopsy in Patients with Early-Stage Endometrial Cancer

Evaluation of Sentinel Lymph Node Biopsy in Patients with Early-Stage Endometrial Cancer - SLN Mapping in Early Endometrial Cancer

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000061061

Enrollment

Registered

2026-04-01

Start date

2026-03-24

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

Early-Stage Endometrial Cancer

Interventions

Sentinel lymph node (SLN) identification is performed using a dual-tracer method combining the radioisotope (RI) technique with either the dye method or indocyanine green (ICG) fluorescence

notably, ICG standalone mapping is excluded from this protocol and would require a separate approved amendment. For the RI method, technetium-99m (99mTc) phytate (38-111 MBq) is injected pericervicall

s previous data in cervical cancer demonstrating 100% sensitivity and negative predictive value, systematic lymphadenectomy is omitted if an SLN is successfully identified. However, if an SLN cannot b

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Diagnosis: Histologically confirmed endometrial cancer. 2. Histological Type and Grade: Preoperative endometrial biopsy showing endometrioid carcinoma, Grade 1 or Grade 2. 3. Clinical Stage and Tumor Size: Preoperative imaging (CT and MRI) indicating Stage IA (FIGO 2008) with an estimated tumor diameter of 2 cm or larger. 4. Age: 18 years of age or older at the time of providing informed consent. 5. Informed Consent: Provision of written informed consent by the patient to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Severe Comorbidities: Presence of severe complications, including but not limited to hepatic, renal, or cardiac disease, bone marrow suppression, or active infection. 2. Drug Hypersensitivity: A history of hypersensitivity or allergic reactions to any of the drugs or agents used in this study (e.g., technetium-99m, Patent Blue, or ICG). 3. Ineligibility as Determined by Investigators: Any other condition that the principal investigator or sub-investigator deems inappropriate for participation in the study.

Design outcomes

Primary

Measure	Time frame
Sentinel Lymph Node (SLN) Detection Rate	—

Secondary

Measure	Time frame
Operating time, Incidence of adverse events, Disease-free survival (DFS), Overall survival (OS)	—

Countries

Japan

Contacts

Public ContactAkihito Horie

Medical Research Institute Kitano Hospital, PIIF Tazuke-Kofukai Obstetrics and Gynecology

akihito-horie@kitano-hp.or.jp06-6312-1221

Outcome results

None listed

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