NCT04492995 - Sentinel Node in Endometrial Cancer | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

70

Conditions

Endometrial Cancer

Interventions

injection via TUMIR of the tracer [99mTc] Tc-albumin nanocoloid-ICG (6 mCi, 4 ml)DIAGNOSTIC_TEST

The day before the surgery, a new scan (planar and SPECT / CT) will be performed after the injection via TUMIR of the tracer \[99mTc\] Tc-albumin nanocoloid-ICG (6 mCi, 4 ml) or the injection via TUMIR of \[99mTc\] Tc-albumin nanocoloid (6mCi, 8ml). The two lymphatic maps will be compared and the number of sentinel nodes identified in each study and the territories of drainage and the difference between them (in number and territories) will be established. On the day of surgery, a cervical injection of methylene blue will be performed at the start of surgery according to usual methodology (2 ml diluted to 50%). Intraoperative detection of the sentinel nodes will take place by visual inspection, using the gammadetector probe and NIR optics. Sentinel node biopsies will be processed according to the usual processing methodology and analysis for the detection of metastases.

injection via TUMIR of [99mTc] Tc-albumin nanocoloid (6mCi, 8ml).DIAGNOSTIC_TEST

The day before the surgery, a new scan (planar and SPECT / CT) will be performed after the injection via TUMIR of the tracer \[99mTc\] Tc-albumin nanocoloid-ICG (6 mCi, 4 ml) or the injection via TUMIR of \[99mTc\] Tc-albumin nanocoloid (6mCi, 8ml). The two lymphatic maps will be compared and the number of sentinel nodes identified in each study and the territories of drainage and the difference between them (in number and territories) will be established. On the day of surgery, a cervical injection of methylene blue will be performed at the start of surgery according to usual methodology (2 ml diluted to 50%). Intraoperative detection of the sentinel nodes will take place by visual inspection, using the gammadetector probe and NIR optics. Sentinel node biopsies will be processed according to the usual processing methodology and analysis for the detection of metastases.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Clínic de Barcelona

Barcelona, Spain

RECRUITING

Outcomes

Primary Outcomes

Proportion of patients with intraoperative detection of sentinel nodes

Time frame: 1 month

Secondary Outcomes

Number of sentinel nodes biopsied during surgery after injection of the [99mTc] hybrid radiotracer Tc-albumin nanocoloid-ICG (hybrid RT) or albumin nanocoloid (RT) radiotracer [99mTc] by myometrial injection guided by transvaginal ultrasound (TUMIR).

Time frame: 1 month

Number of sentinel lymph nodes with lymph node infiltration detected during surgery after injection of hybrid RT or RT by guided myometrial injection by transvaginal ultrasound (TUMIR)

Time frame: 1 month

Number of lymph nodes with lymph node infiltration detected in the piece of lymphadenectomy after injection of hybrid RT or RT by TUMIR injection lymphadenectomy after injection of hybrid RT or RT by TUMIR injection

Time frame: 1 month

Number of false negative results after injection of the hybrid RT or RT by transvaginal ultrasound-guided myometrial injection (TUMIR).

Time frame: 1 month

Difference in the number of sentinel nodes visualized after injection of the hybrid RT or RT between TUMIR lymphogammagraphy and cervical lymphogammagraphy

Time frame: 1 month

Difference in the drainage pattern of each radiotracer (hybrid RT and RT) between the cervical injection and transvaginal ultrasound-guided myometrial injection (TUMIR).

Time frame: 1 month

Causes of non-drainage of the hybrid RT or RT in the cervical injection or in the Transvaginal ultrasound-guided myometrial injection (TUMIR).

Time frame: 1 month

Central Contacts

Pilar Paredes, MD

CONTACT

+34932275400 pparedes@clinic.cat

Sergi Vidal

CONTACT

+34932275400 svidal@clinic.cat