Clinical trial · Observational
High-frequency Ultrasound for Intraoperative Lymph Node Assessment in Gynecological Cancer: From Surgery to Radiomics
High Frequency Ultrasound Imaging for Intraoperative Lymph Nodal Assessment in Gynecological Cancer: From Image-guided Surgery to Radiomics Applications
- 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)
Lymph node assessment is crucial in gynecological cancers (ovarian, endometrial, cervical, and vulvar), as nodal involvement significantly impacts prognosis and treatment. Despite high morbidity, systematic lymphadenectomy has been widely used for staging and treatment planning. However, in most cases, lymph nodes are free from metastasis, making the procedure unnecessary and exposing patients to severe complications such as lymphedema and infections. Sentinel lymph node (SLN) evaluation has emerged as a less invasive alternative, reducing unnecessary lymphadenectomies. However, SLN techniques face challenges, including detection failures, inaccurate frozen section analysis, and imaging limitations like false negatives in FDG PET/CT scans. The need for improved intraoperative imaging techniques is emphasized to enhance lymph node assessment, minimize surgical risks, and better tailor treatment approaches.
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 |
|---|---|---|---|
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Evaluation of HFUS Accuracy in Detecting Lymph Node Metastases in Gynecological Cancer
- timeFrame
- Days 20
- description
- The aim of this prospective trial is to report the sensivity, specificity, NPV, PPV and accuracy of HFUS in the metastasis detection (macro, micro and ITCs) from fresh, unstained ex vivo/in vivo lymph node samples.
Secondary outcomes (2)
- measure
- Minimum Size Detection Limit of HFUS Imaging
- timeFrame
- 2 minutes
- description
- To assess the lowest size detectable with the adopted imaging technique
- measure
- Development of a Radiomic Algorithm for Lymph Node Assessment
- timeFrame
- 6 months
- description
- To develop a radiomic algorithm for the assesment of the lymphn node status
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Women undergoing surgery for gynecological malignancies (ovarian, endometrial, cervical, and vulvar cancer) * Need for nodal excision (staging or cytoreductive reasons) * 18-99 years old * Absence of contemporary lymphatic diseases * Absence of previous oncological disease in the last 5 years * Willingness to participate in the study and to provide informed consent Exclusion Criteria: * Previous radiotherapy treatments * Previous chemotherapy treatments
References
Publications (0)
Data not yet available