Recruiting NCT05937620
Sentinel Node Detection With Technetium-99m Albumin Nanocolloid and ICG in Patients With Epithelial Ovarian Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 99mTC nanocolloid albumin injection, ICG injection.
- Who it may be relevant to
- Registry conditions: Ovarian Epithelial Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Sentinel Node Detection With Technetium-99m Albumin Nanocolloid and Indocyanine Green (ICG) in Patients With Epithelial Ovarian Cancer in Early Stages: Pilot Study
Overview
Study to evaluate the diagnostic precision of ICG and 99mTc nanocolloid albumin in sentinel lymph node detection in early ovarian epithelial cancer.
Interventions
- Diagnostic test 99mTC nanocolloid albumin injection
All patients will receive an injection of both tracers in order to detect the sentinel lymph node - Diagnostic test ICG injection
All patients will receive an injection of both tracers in order to detect the sentinel lymph node
Primary outcome measures
- Evaluation of the diagnostic efficiency of both tracers in sentinel lymph node detection [Time frame: Through study completion (an average of 36 months)]
Secondary outcome measures (12)
- Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to morphological characteristics [Time frame: Through study completion (an average of 36 months)]
- Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to pathology results. [Time frame: Through study completion (an average of 36 months)]
- Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to International Federation of Gynecology and Obstetrics (FIGO) stage [Time frame: Through study completion (an average of 36 months)]
- Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to biochemistry results. [Time frame: Through study completion (an average of 36 months)]
- Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to surgical approach [Time frame: Through study completion (an average of 36 months)]
- Evaluation of anatomical distribution of 99mTC draining [Time frame: Through study completion (an average of 36 months)]
- Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to morphological characteristics. [Time frame: Through study completion (an average of 36 months)]
- Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to pathology results. [Time frame: Through study completion (an average of 36 months)]
- Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to FIGO stage. [Time frame: Through study completion (an average of 36 months)]
- Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to biochemistry results. [Time frame: Through study completion (an average of 36 months)]
- Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to surgical approach. [Time frame: Through study completion (an average of 36 months)]
- Evaluation of the performance of intraoperative Near Infrared (NIR) camera in the display of ovarian lymphatic map according to morphological characteristics [Time frame: Through study completion (an average of 36 months)]
Eligibility criteria
Inclusion criteria
- Patients with adnexal mass diagnosed with high suspicion of malignancy that will undergo intraoperative biopsy or patients with already diagnosed epithelial cancer in early stages in a previous surgery and confirmed by pathology with complete staging indicated.
- Absence of retroperitoneal ganglionary affectation and metastatic disease evaluated by preoperative imaging techniques.
- Signing of informed consent by the patient or relative in charge.
- Women with childbearing potential must compromise to use highly effective contraceptive methods (partner vasectomized, sexual abstinence) until the end of the study (last study visit).
Exclusion criteria
- Patients <18 years
- Pregnancy or breastfeeding
- Epithelial ovarian tumors stage FIGO III or IV.
- Impossibility to obtain a biopsy from the tumor.
- History of previous vascular surgery (cava vein, aorta, iliac blood vessels) or radiotherapy in pelvic or para-aortic area.
- Sentinel lymph node biopsy will not be performed if intraoperative histologic study shows a benign ovarian tumor, low malignancy potential tumor or expansive mucinous histology.
- Patient not able to undergo surgery.
- Hypersensitivity to active principle, to sodium iodide or iodine allergy.
- Patients with clinic hyperthyroidism, thyroid autonomous adenomas or focal and diffused autonomous alteration of thyroid gland
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Spain · 1 center
- Laura Burunat — Barcelona
Identifiers
NCT: NCT05937620 · 2023-505667-37-00