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A randomized controlled and multicenter study of carbon nanoparticles and ICG fluorescence for sentinel lymph node biopsy in early stage endometrial cancer

A randomized controlled and multicenter study of carbon nanoparticles and ICG fluorescence for sentinel lymph node biopsy in early stage endometrial cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100045728
Enrollment
Unknown
Registered
2021-04-23
Start date
2021-04-30
Completion date
Unknown
Last updated
2021-12-06

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

Conditions

Endometrial Cancer

Interventions

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Sponsors

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.18-70 years old; 2.Diagnosed as endometrial cancer by pathological biopsy under hysteroscope or diagnostic curettage; 3.Clinically diagnosed stage I endometrial cancer; 4.Systemic imaging (thoracoabdominal enhanced CT or PET-CT) was used to assess the absence of retroperitoneal lymphatic metastasis and distant metastasis; 5.With ECOG<=2 points, hysterectomy and pelvic and para-aortic lymph node resection could be tolerated; 6.Volunteer to participate in the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1.Endometrial cancer patients suspected of cervical invasion or extrauterine tumor invasion by gynecological examination and imaging; 2.Allergic constitution, allergic to iodine or ICG skin test is positive; 3.Patients who has received radiotherapy or chemotherapy before enrollment; 4.History of primary malignancy other than endometrial cancer; 5.Patients combined with severe medical and surgical diseases, are unable to tolerate surgery; 6.Patients considered unsuitable for inclusion by the researchers; 7.Obvious dysfunction or chronic disease of heart, liver and kidney, or history of other malignant tumors.

Design outcomes

Primary

MeasureTime frame
Overall sentinel node detection rate;

Secondary

MeasureTime frame
Bilateral sentinel node detection rate;The number of detected sentinel nodes;Location of sentinel node;Sensitivity of sentinel node biopsy;False negative rate of sentinel lymph node biopsy;Sentinel lymph node biopsy negative predictive value;Duration of operation;Intraoperative bleeding volume;

Countries

China

Contacts

Public ContactLi Bin

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

libin@cicams.ac.cn+86 10 67788275

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026