Clinical trial · Interventional
Sentinel Node in Endometrial Cancer
Sentinel Node in Endometrial Cancer by Detection of Hybrid ([99mTc] Tc-albumin Nanocoloid-ICG). A Comparative Pilot Study Between the Lymphatic Map Derived From the Cervical Puncture Versus Myometrial
- 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)
Phase II, open-label, randomized pilot study. Patients will be randomized (1:1) to receive for sentinel node screening: 1. Radiotracer (RT) via cervical administration and TUMIR 2. Combination of RT with Indocyanine Green (RT + ICG) via cervical administration and TUMIR Patients will be followed up to 1 month after the last administration of radiotracer 70 patients will be included into the study.
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 |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| injection via TUMIR of [99mTc] Tc-albumin nanocoloid (6mCi, 8ml). | Diagnostic Test | — | UNRESOLVED |
| injection via TUMIR of the tracer [99mTc] Tc-albumin nanocoloid-ICG (6 mCi, 4 ml) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Radiotracer + TUMIR
- description
- TUMIR = transvaginal ultrsound-guided myometrial injection
- interventionNames
- Diagnostic Test: injection via TUMIR of the tracer [99mTc] Tc-albumin nanocoloid-ICG (6 mCi, 4 ml)
- type
- EXPERIMENTAL
- label
- (Radiotraces + ICG) + TUMIR
- description
- ICG =indocyanine green TUMIR = transvaginal ultrsound-guided myometrial injection
- interventionNames
- Diagnostic Test: injection via TUMIR of [99mTc] Tc-albumin nanocoloid (6mCi, 8ml).
Primary outcomes (1)
- measure
- Proportion of patients with intraoperative detection of sentinel nodes
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years. 2. Histological diagnosis of endometrial cancer with criteria of high risk according to the following criteria: - unfavorable histology according to FIGO (adenocarcinoma serous, clear cell, or carcinosarcoma) - nuclear grade 3 - suspected myometrial invasion\> 50% by resonance magnetic (MR) or transvaginal ultrasound 3. Women of childbearing age should have a transvaginal ultrasound who rule out pregnancy and must commit to using methods highly effective contraceptives (vasectomized couple and sexual abstinence) until the hysterectomy is performed. 4. Patient who gives written informed consent. Exclusion Criteria: 1. Pregnancy or lactation. 2. Suspected lymph node or distant metastatic disease in the preoperative study. 3. History of previous surgery or radiotherapy in the pelvic and paraortic lymphatic drainage areas or nodal involvement of any other etiology. 4. Body mass index (BMI) greater than 45 Kg / m2. 5. Patients who, in the researcher's opinion, are not suitable for participate, regardless of reason, including medical or clinical, or participants potentially at risk of not comply with the study procedures. 6. Known hypersensitivity to some of the active substances or excipients from RT or ICG (including previous history of hypersensitivity to products containing human albumin). 7. Hypersensitivity to sodium iodide. 8. Patients allergic to iodine. 9. Patients with clinical hyperthyroidism, thyroid adenomas autonomic and diffuse focal and autonomic disturbances of the gland thyroid.
References
Publications (1)
- DERIVEDvan Oosterom MN, Diaz-Feijoo B, Santisteban MI, Sanchez-Izquierdo N, Perissinotti A, Glickman A, Marina T, Torne A, van Leeuwen FWB, Vidal-Sicart S. Steerable DROP-IN radioguidance during minimal-invasive non-robotic cervical and endometrial sentinel lymph node surgery. Eur J Nucl Med Mol Imaging. 2024 Aug;51(10):3089-3097. doi: 10.1007/s00259-023-06589-3. Epub 2024 Jan 18. PMID 38233608