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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFundacion Clinic per a la Recerca Biomédica

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Patients <18 years

Pregnancy or breastfeeding

Epithelial ovarian tumors stage FIGO III or IV.

Impossibility to obtain a biopsy from the tumor.

Trial design

Design model

Single group

Treatments tested in this trial

  • 99mTC nanocolloid albumin injection

    Diagnostic test

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

  • ICG injection

    Diagnostic test

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

Treatment groups

62 Participants
are divided into 1 treatment group
Group A: Interventional armExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Evaluation of the diagnostic efficiency of both tracers in sentinel lymph node detection

Global detection rate of sentinel lymph node in patients having received both tracers.

Time frame
Through study completion (an average of 36 months)

Secondary outcomes

1

Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to morphological characteristics

Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by morphologic characteristics.

Time frame
Through study completion (an average of 36 months)
2

Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to pathology results.

Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by pathology results

Time frame
Through study completion (an average of 36 months)
3

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

Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by FIGO stage

Time frame
Through study completion (an average of 36 months)
4

Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to biochemistry results.

Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by biochemistry results

Time frame
Through study completion (an average of 36 months)

Other outcomes

Sponsors and contacts

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