Sentinel Node Detection With Technetium-99m Albumin Nanocolloid and ICG in Patients With Epithelial Ovarian Cancer

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-30

Study Completion Date

2026-10-31

Brief Summary

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

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Detailed Description

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Conditions

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Ovarian Epithelial Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Interventional arm

All patients will receive an injection of ICG and an injection of 99mTc nanocolloid albumin

Group Type EXPERIMENTAL

99mTC nanocolloid albumin injection

Intervention Type DIAGNOSTIC_TEST

All patients will receive an injection of both tracers in order to detect the sentinel lymph node

ICG injection

Intervention Type DIAGNOSTIC_TEST

All patients will receive an injection of both tracers in order to detect the sentinel lymph node

Interventions

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99mTC nanocolloid albumin injection

All patients will receive an injection of both tracers in order to detect the sentinel lymph node

Intervention Type DIAGNOSTIC_TEST

ICG injection

All patients will receive an injection of both tracers in order to detect the sentinel lymph node

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No