Clinical trial · Interventional
Sentinel Lymph Node Detection in Early Cervical Cancer
- 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)
The primary objective of this study is to determine the feasibility of detecting the sentinel lymph node (SLN) in patients with early invasive cervical cancer using a combined radioisotope and blue dye technique. The investigators hypothesize that the sentinel lymph node (first node draining the tumour/cervix) for early stage cervical cancer represents the status of the regional lymph node basin (pelvic lymph nodes) and identification of a negative SLN would negate the need for complete pelvic lymphadenectomy.
Conditions
Conditions (1)
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 Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Preoperative and intraoperative SLN Mapping | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sentinel lymph node mapping
- description
- Patients who consent to the study will have preoperative and intraoperative SLN mapping performed. This will include injection of a radioisotope (Technetium 99) into the cervix and imaging (SPECT/CT) at Nuclear Medicine in the morning prior to surgery in an effort to identify the lymph node basin containing the sentinel nodes. Intraoperatively, blue dye will also be injected into the cervix to aid in location of the sentinel nodes.
- interventionNames
- Procedure: Preoperative and intraoperative SLN Mapping
Primary outcomes (1)
- measure
- Sensitivity of sentinel lymph node (SLN) detection in patients with early invasive cervical cancer using a combined radioisotope and blue dye technique.
- timeFrame
- Three years
Secondary outcomes (1)
- measure
- SLN status correspondence with the overall pelvic lymph node positivity (specificity) as determined by lymphadenectomy (gold standard).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women with invasive adenocarcinoma or squamous cell carcinoma of the cervix 2. Stages 1A1 (+LVSI), 1A2 and 1B1 (\< 4 cm) 3. If CT, MRI or PET have been performed preoperatively there must be no clear evidence of metastatic disease and/or parametrial involvement. 4. Patients who have signed an approved informed consent. 5. Patients who will undergo surgery that includes a radical hysterectomy and/or radical trachelectomy and bilateral lymphadenectomy via laparotomy, laparoscopy or robotic-assisted. Exclusion Criteria: 1. Patients with known allergy to triphenylmethane compounds 2. Pregnant patient 3. Patients with previous retroperitoneal surgery 4. Patients with previous history of pelvic/abdominal radiation 5. Patients with recurrent cervical cancer 6. Any patient treated with neoadjuvant chemotherapy and/or radiation
References
Publications (0)
Data not yet available