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A randomized controlled comparison study of carbon nanoparticles and indocyanine green for sentinel lymph node biopsy in early stage cervical cancer

A randomized controlled comparison study of carbon nanoparticles and indocyanine green for sentinel lymph node biopsy in early stage cervical cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100054262
Enrollment
Unknown
Registered
2021-12-12
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-11-14

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

Conditions

Cervical cancer

Interventions

SLNB).
Gold Standard:Systematic pelvic lymph node dissection, and routine pathological examination of each dissected lymph node.
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Sponsors

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

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of cervical squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma by pathological biopsy; 2. The clinical stage is IB1 (FIGO 2018); 3. Whole body imaging (enhanced chest-abdominal-pelvic CT or PET-CT) assesses no distant metastasis; 4. Aged 18-70 years; 5. Physical strength score ECOG<=2 points, can tolerate extensive hysterectomy and pelvic lymph node dissection; 6. No obvious heart, liver, kidney chronic disease or dysfunction, and no history of other malignant tumors; 7. Voluntarily participate in the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Residual cervical cancer; 2. The pathological type is small cell carcinoma, neuroendocrine carcinoma and other special types; 3. Those who have received radiotherapy or chemotherapy before enrollment; 4. Allergic constitution, allergic to iodine; 5. ICG skin test positive; 6. Patients deemed unsuitable for inclusion by the investigator.

Design outcomes

Primary

MeasureTime frame
Overall sentinel node detection rate;

Secondary

MeasureTime frame
Bilateral sentinel node detection rate;Number of detected sentinel nodes;Location of sentinel node;Sensitivity of sentinel node biopsy;False negative rate of sentinel lymph node biopsy;Negative predictive value of sentinel lymph node biopsy;Duration of operation;Intraoperative bleeding volume;Tracer allergy;Operative complications;Low volume metastasis rate of lymph node;

Countries

China

Contacts

Public ContactLi Bin
libin@cicams.ac.cn+86 13801364117

Outcome results

None listed

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