Clinical trial · Interventional
Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer
Lymphatic Mapping and Sentinel Node Identification in Patients With Stage1B1 Cervical Carcinoma
NCT00070317CI-TRIAL-00030174terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This clinical trial is studying how well lymph node mapping and sentinel lymph node identification work in finding lymph node metastases in patients with stage IB1 cervical cancer. Diagnostic procedures, such as lymph node mapping and sentinel lymph node identification, performed before and during surgery, may improve the ability to detect lymph node metastases in patients who have cervical cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Adenocarcinoma | Cervical Adenocarcinoma | CURATED_BROADER | 0.80 |
| Cervical Adenosquamous Carcinoma | Cervical Adenosquamous Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Cervical Squamous Cell Carcinoma | Cervical Squamous Cell Carcinoma | CURATED_BROADER | 0.80 |
| Stage I Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Isosulfan Blue | Drug | — | UNRESOLVED |
| Lymphangiography | Procedure | — | UNRESOLVED |
| Lymph Node Mapping | Procedure | — | UNRESOLVED |
| Methylene Blue | Drug | — | UNRESOLVED |
| Radionuclide Imaging | Procedure | — | UNRESOLVED |
| Sentinel Lymph Node Biopsy | Procedure | — | UNRESOLVED |
| Technetium Tc-99m Sulfur Colloid | Radiation | — | UNRESOLVED |
| Therapeutic Conventional Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic
- description
- Patients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor 6 hours prior to or after induction of anesthesia right before surgery. Patients then undergo radical hysterectomy and complete pelvic and low para-aortic lymphadenectomy. Intraoperatively, patients undergo lymphatic mapping and sentinel lymph node identification using isosulfan blue or methylene blue injected at 4 locations in the cervix and a hand-held gamma counter.
- interventionNames
- Drug: Isosulfan Blue
- Procedure: Lymph Node Mapping
- Procedure: Lymphangiography
- Drug: Methylene Blue
- Procedure: Radionuclide Imaging
- Procedure: Sentinel Lymph Node Biopsy
- Radiation: Technetium Tc-99m Sulfur Colloid
- Procedure: Therapeutic Conventional Surgery
Primary outcomes (2)
- measure
- Sensitivity
- timeFrame
- At the time of surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of carcinoma of the cervix of 1 of the following cellular types: * Squamous cell carcinoma * Adenocarcinoma * Adenosquamous cell carcinoma * Stage IB1 disease (no greater than 4 cm) * No unequivocal evidence of metastases * Adequate surgical candidate * No known allergy to triphenylmethane compounds * No prior pelvic irradiation * No prior retroperitoneal surgery * More than 4 weeks since prior cold knife or loop electrosurgical excision procedure (LEEP) cone biopsy * Prior cone biopsy allowed provided current disease is stage IB1
References
Publications (0)
Data not yet available
No reference posted for this study.