Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
70 participants
INTERVENTIONAL
2020-10-05
2023-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Radiotracer + TUMIR
TUMIR = transvaginal ultrsound-guided myometrial injection
injection via TUMIR of the tracer [99mTc] Tc-albumin nanocoloid-ICG (6 mCi, 4 ml)
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.
(Radiotraces + ICG) + TUMIR
ICG =indocyanine green TUMIR = transvaginal ultrsound-guided myometrial injection
injection via TUMIR of [99mTc] Tc-albumin nanocoloid (6mCi, 8ml).
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.
Interventions
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injection via TUMIR of the tracer [99mTc] Tc-albumin nanocoloid-ICG (6 mCi, 4 ml)
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).
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 Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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Judit Pich Martínez
OTHER
Responsible Party
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Judit Pich Martínez
Clinical Research Manager
Principal Investigators
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Pilar Paredes, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic of Barcelona
Sergi Vidal
Role: PRINCIPAL_INVESTIGATOR
Hospital Clinic of Barcelona
Locations
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Hospital Clínic de Barcelona
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Pilar Paredes, MD
Role: primary
References
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van 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.
Other Identifiers
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2020-001970-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
HYBRID-ENDONODE
Identifier Type: -
Identifier Source: org_study_id
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