Clinical trial NCT05937620: Sentinel Node Detection With Technetium-99m Albumin Nanocolloid and ICG in Patients With Epithelial Ovarian Cancer
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ovarian Epithelial Cancer
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Study to evaluate the diagnostic precision of ICG and 99mTc nanocolloid albumin in sentinel lymph node detection in early ovarian epithelial cancer.


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

Primary outcomes:
measure: Evaluation of the diagnostic efficiency of both tracers in sentinel lymph node detection
timeFrame: Through study completion (an average of 36 months)
Secondary outcomes:
measure: Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to morphological characteristics
timeFrame: Through study completion (an average of 36 months)
measure: Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to pathology results.
timeFrame: Through study completion (an average of 36 months)
measure: 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
timeFrame: Through study completion (an average of 36 months)
measure: Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to biochemistry results.
timeFrame: Through study completion (an average of 36 months)
measure: Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to surgical approach
timeFrame: Through study completion (an average of 36 months)
measure: Evaluation of anatomical distribution of 99mTC draining
timeFrame: Through study completion (an average of 36 months)
measure: Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to morphological characteristics.
timeFrame: Through study completion (an average of 36 months)
measure: Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to pathology results.
timeFrame: Through study completion (an average of 36 months)
measure: Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to FIGO stage.
timeFrame: Through study completion (an average of 36 months)
measure: Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to biochemistry results.
timeFrame: Through study completion (an average of 36 months)
measure: Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to surgical approach.
timeFrame: Through study completion (an average of 36 months)
measure: Evaluation of the performance of intraoperative Near Infrared (NIR) camera in the display of ovarian lymphatic map according to morphological characteristics
timeFrame: Through study completion (an average of 36 months)
measure: Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to pathology results.
timeFrame: Through study completion (an average of 36 months)
measure: Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to FIGO stage.
timeFrame: Through study completion (an average of 36 months)
measure: Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to biochemistry results.
timeFrame: Through study completion (an average of 36 months)
measure: Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to surgical approach.
timeFrame: Through study completion (an average of 36 months)
measure: Anatomical distribution of sentinel lymph node detected with ICG.
timeFrame: Through study completion (an average of 36 months)
measure: Anatomical distribution of sentinel lymph node detected with 99mTC albumin nanocolloid.
timeFrame: Through study completion (an average of 36 months)
measure: Comparison of lymph node detection with both tracers.
timeFrame: Through study completion (an average of 36 months)
measure: Evaluation of ultra-staging in micrometastases detection compared to conventional histology.
timeFrame: Through study completion (an average of 36 months)
measure: Evaluation of the complications associated with each technique.
timeFrame: Through study completion (an average of 36 months)
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Berta Diaz-Feijoo, Physician
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinic of Barcelona
name: Aureli Torné, Physician
role: PRINCIPAL_INVESTIGATOR
References: