Clinical trial · Interventional
Intra-Operative Lymphatic Mapping in Patients With Invasive Carcinoma of the Cervix or Endometrial Carcinoma
- 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 purpose of this study is to learn if a surgical technique called intraoperative lymphatic mapping can accurately identify the lymph node that is at greatest risk if endometrial or cervical cancer spreads to the lymph nodes. Early cervical cancer is usually treated by removing the cervix, tissue around the cervix, and the upper vagina. If needed, the uterus is also removed. The treatment also includes removing lymph nodes from the pelvis. Endometrial cancer is usually treated by removing the cervix, uterus, fallopian tubes and ovaries. The treatment also includes removing lymph nodes from the pelvis.
Conditions
Conditions (3)
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 |
| Cervical Carcinoma | Cervical Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lymphatic Mapping | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Other: Lymphatic Mapping
Primary outcomes (1)
- measure
- To determine the feasibility of identifying the sentinel lymph node in patients with endometrial and invasive cervical cancer using a combination of radioisotope and blue dye.
- timeFrame
- 7 years
Secondary outcomes (2)
- measure
- To determine the feasibility of locating sentinel nodes in the pelvis and/or paraaortic region with preoperative lymphoscintigraphy.
- timeFrame
- 7 years
- measure
- To document the location of the sentinel nodes in patients with invasive cervical cancer.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients with endometrial cancer diagnosed on endometrial biopsy or dilatation and curettage. * Patients with invasive cervical cancer diagnosed on cervical biopsy or cone biopsy. * Patients with a performance status of 0, 1, 2, or 3 by the Gynecologic Oncology Group criteria (Appendix). * Patients with stage I to \~IIA invasive cervical cancer disease according to the International Federation of Gynecology and Obstetrics (FIGO) clinical staging criteria (Appendix). * Patients with clinical stage I endometrial cancer * Patients who will undergo surgery to include a hysterectomy, radical hysterectomy and/or radical trachelectomy and bilateral lymphadenectomy via laparotomy or laparoscopy * Patients who have signed an approved informed consent. Exclusion Criteria: * Patients with history of prior pelvic or para-aortic lymphadenectomy. * Patients with stage IIB-IV invasive cervical cancer by FIGO criteria. * Patients with recurrent endometrial or cervical cancer. * Patients with prior pelvic radiation. * Any patient with endometrial or cervical cancer treated with neoadjuvant chemotherapy and radiation therapy. * Patients with a performance score of 4 by the Gynecologic Oncology Group criteria or who are not good surgical candidates (Appendix). * Patients with grossly infected primary tumors. * Patients with known allergy to triphenyl-ethane compounds. * Patients with known deficiency of Glucose-G-Phosphate Dehydrogenase. * Patients with known Hemolytic Anemia from Pyruvate Kinase and G6PD Deficiencies. * Severe Renal Disease.
References
Publications (0)
Data not yet available