Clinical trial · Interventional
The Combination of Preoperative MRI and SLN in the Surgical Management of CC and EC
The Combination of Preoperative MRI and Sentinel Lymph Node Biopsy（SLN） in the Surgical Management of Cervical and Endometrial Cancer
NCT05942170CI-TRIAL-00067944unknownN/AClinicalTrials.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)
The aim of the study was to evaluate the diagnostic value of MRI and/or SLN mapping alone or in combination in cervical (CC) and endometrial cancer (EC) patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| MRI | — | UNRESOLVED | — |
| Sentinel Lymph Node Biopsy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ICG/ blue dye | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- SLN/MRI
- interventionNames
- Drug: ICG/ blue dye
Primary outcomes (4)
- measure
- Sensitivity of the preoperative MRI and SLN mapping, alone or in combination
- timeFrame
- 7 days
- description
- Clinical-pathologic characteristics were evaluated using basic descriptive statistics. The Sensitivity, of MRI, SLN biopsy, and the combination of MRI and SLN biopsy in identifying metastatic lymph nodes were calculated. A true positive was defined as a positive MRI or SLN in the presence of metastatic disease to the pelvic lymph nodes. A true negative was defined as a negative MRI and SLN in the absence of metastatic disease to the pelvic lymph nodes. A false positive was defined as a positive MRI in the absence of metastatic disease to the pelvic lymph nodes. A false negative was defined as a negative MRI or SLN in the presence of metastatic disease in the pelvic lymph nodes. Ninety-five percent confidence intervals (CIs) were calculated according to the standard normal distribution. These analyses were performed for the entire population. Statistical analysis was performed with GraphPad Prism 9.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 41 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * histopathological diagnosis of cervical cancer or endometrial cancer * complete case data * preoperative MRI examinations completed * initial treatment is surgical * all surgeries are entirely staged. Exclusion Criteria: * patients with suspected extrauterine involvement * allergic to tracers * previous history of surgery or radiotherapy to nodal areas * contraindication for surgical treatment (due to age or comorbidities).
References
Publications (0)
Data not yet available
No reference posted for this study.