Patients with endometrial cancer who are going to undergo surgery for the primary tumor and lymph node study using lymphadenectomy and detection of the sentinel node MedDRA version: 21.0 Level: PT Classification code 10014733 Term: Endometrial cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: [99mTc]Tc-nanocoloide de albúmina-ICG
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: human albumin nanocolloids
Other descriptive name: TECHNETIUM (99MTC) HUMAN ALBUM
Sponsors
Fundació Clínic per a la Recerca Biomèdica
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years. 2. Histological diagnosis of endometrial cancer with high risk criteria according to the following criteria: - unfavorable histology according to FIGO (serous adenocarcinoma, clear cell or carcinosarcoma) - nuclear grade 3 - suspected myometrial invasion> 50% by magnetic resonance imaging (MRI) or transvaginal ultrasound 3. Women of childbearing age must have a transvaginal ultrasound that rules out pregnancy and must commit to using highly effective contraceptive methods (vasectomized partner and sexual abstinence) until the hysterectomy is performed. 4. Patient who gives written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
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 areas of pelvic and paraortic lymph node drainage or lymph node involvement of any other etiology. 4. Body mass index (BMI) greater than 45 Kg / m2. 5. Patients who, in the judgment of the investigator, are not eligible to participate, regardless of reason, including medical or clinical conditions, or participants potentially at risk of not complying with the study procedures. 6. Known hypersensitivity to some of the active substances or excipients of 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, autonomous thyroid adenomas, and diffuse focal and autonomic abnormalities of the thyroid gland.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the ratio of intraoperative sentinel node detection in endometrial cancer using the hybrid detection of RT and ICG ([99mTc] Tc-albumin nanocoloid-ICG);Secondary Objective: 1. To evaluate if the proportion of intraoperative detection of the sentinel node (GC) in endometrial cancer using the detection of the hybrid radiotracer [99mTc] Tc-albumin nanocoloid-ICG (hybrid RT) is higher than that obtained by injecting only the radiotracer [99mTc] Tc-albumin nanocoloid (RT). 2. To estimate the diagnostic capacity parameters of hybrid RT detection by transvaginal ultrasound-guided myometrial injection (TUMIR). 3. To compare the lymphatic map obtained by detection of the hybrid RT or by exclusive detection with RT according to the cervical injection route or the TUMIR. 4. Incidence of hypersensitivity reactions and adverse events related to tracer injection (hybrid RT and RT);Primary end point(s): Proportion of patients with intraoperative detection of GCs.;Timepoint(s) of evaluation of this end point: day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Number of sentinel lymph nodes (GC) biopsied during surgery after injection of the hybrid [99mTc] Tc-albumin nanocoloid-ICG (hybrid RT) or radiotracer [99mTc] Tc-albumin nanocoloid (RT) by myometrial injection guided by transvaginal ultrasound (TUMIR). 2. Number of sentinel lymph nodes with lymph node infiltration detected during surgery after injection of the hybrid RT or RT by transvaginal ultrasound-guided myometrial injection (TUMIR). 3. Number of lymph nodes with lymph node infiltration detected in the lymphadenectomy piece after injection of the hybrid RT or RT by transvaginal ultrasound-guided myometrial injection (TUMIR). 4. Number of false negative results after injection of hybrid RT or RT by transvaginal ultrasound-guided myometrial injection (TUMIR). False negatives will be defined as the number of patients with lymph node infiltration in at least one lymph node of the lymphadenectomy piece and sentinel node negative for lymph node infiltration. 5. Difference in the number of GC visualized after injection of the hybrid RT or RT between TUMIR lymphogammagraphy and cervical lymphogammagraphy. 6. Difference in the drainage pattern of each radiotracer (hybrid RT and RT) between cervical injection and transvaginal ultrasound-guided myometrial injection (TUMIR). 7. Causes of non-drainage of hybrid RT or RT in cervical injection or in transvaginal ultrasound-guided myometrial injection (TUMIR). 8. Difference between the proportion of paraortic GC detected after injection of each of the radiotracers (hybrid RT and RT) during surgery. 9. Proportion of patients with hypersensitivity reactions related to the injection of each of the two radiotracers (hybrid RT and RT). 10. Proportion of patients with adverse events related to the injection of one of the two radiotracers (hybrid RT and RT). 11. Surgical detection time of GCs during intraoperative detection after injection of each of the two radiotracers (hybrid RT and RT). 12. Histologica | — |
Countries
Spain
Contacts
Public ContactPilar Paredes
Hospital Clínic. Servicio de Medicina Nuclear
Outcome results
None listed