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

Primary Purpose

Ovarian Epithelial Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
99mTC nanocolloid albumin injection
ICG injection
Sponsored by
Fundacion Clinic per a la Recerca Biomédica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ovarian Epithelial Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Interventional arm

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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
    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
    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
    Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to surgical approach
    Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by surgical approach
    Evaluation of anatomical distribution of 99mTC draining
    Detection rate of sentinel lymph node with 99mTC in the group of patients having received the tracer
    Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to morphological characteristics.
    Detection rate and false negative rate of intraoperative detector gamma probe,stratified by morphologic characteristics.
    Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to pathology results.
    Detection rate and false negative rate of intraoperative detector gamma probe,stratified by pathology results.
    Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to FIGO stage.
    Detection rate and false negative rate of intraoperative detector gamma probe,stratified by FIGO stage.
    Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to biochemistry results.
    Detection rate and false negative rate of intraoperative detector gamma probe,stratified by biochemistry results.
    Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to surgical approach.
    Detection rate and false negative rate of intraoperative detector gamma probe,stratified by surgical approach.
    Evaluation of the performance of intraoperative Near Infrared (NIR) camera in the display of ovarian lymphatic map according to morphological characteristics
    Detection rate and false negative rate of intraoperative NIR camera,stratified by morphological characteristics
    Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to pathology results.
    Detection rate and false negative rate of intraoperative NIR camera,stratified by pathology results.
    Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to FIGO stage.
    Detection rate and false negative rate of intraoperative NIR camera,stratified by FIGO stage.
    Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to biochemistry results.
    Detection rate and false negative rate of intraoperative NIR camera,stratified by biochemistry results.
    Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to surgical approach.
    Detection rate and false negative rate of intraoperative NIR camera,stratified by surgical approach.
    Anatomical distribution of sentinel lymph node detected with ICG.
    Anatomical location of sentinel lymph node according to ICG.
    Anatomical distribution of sentinel lymph node detected with 99mTC albumin nanocolloid.
    Anatomical location of sentinel lymph node according to 99mTC albumin nanocolloid.
    Comparison of lymph node detection with both tracers.
    Assessment of concordance of sentinel lymph node anatomical location detected with each tracer.
    Evaluation of ultra-staging in micrometastases detection compared to conventional histology.
    Pathology ultra-staging evaluation. The following classification will be considered according to the criteria of the American Joint Committee on Cancer (AJCC): Macrometastases: tumor infiltration > 2 mm in maximum diameter. Micrometastases: tumor infiltration between 0.2 and 2 mm in maximum diameter. Isolated tumor cells or isolated cell group (CTA, GCA): clusters of cells smaller than 0.2 mm
    Evaluation of the complications associated with each technique.
    Chirurgic and post-operative complications, directly or indirectly associated to the use of the tracers.

    Full Information

    First Posted
    June 20, 2023
    Last Updated
    September 15, 2023
    Sponsor
    Fundacion Clinic per a la Recerca Biomédica
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05937620
    Brief Title
    Sentinel Node Detection With Technetium-99m Albumin Nanocolloid and ICG in Patients With Epithelial Ovarian Cancer
    Acronym
    Melisa-II
    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

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    October 2026 (Anticipated)
    Study Completion Date
    October 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fundacion Clinic per a la Recerca Biomédica

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ovarian Epithelial Cancer

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    62 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Interventional arm
    Arm Type
    Experimental
    Arm Description
    All patients will receive an injection of ICG and an injection of 99mTc nanocolloid albumin
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    99mTC nanocolloid albumin injection
    Intervention Description
    All patients will receive an injection of both tracers in order to detect the sentinel lymph node
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    ICG injection
    Intervention Description
    All patients will receive an injection of both tracers in order to detect the sentinel lymph node
    Primary Outcome Measure Information:
    Title
    Evaluation of the diagnostic efficiency of both tracers in sentinel lymph node detection
    Description
    Global detection rate of sentinel lymph node in patients having received both tracers.
    Time Frame
    Through study completion (an average of 36 months)
    Secondary Outcome Measure Information:
    Title
    Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to morphological characteristics
    Description
    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)
    Title
    Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to pathology results.
    Description
    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)
    Title
    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
    Description
    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)
    Title
    Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to biochemistry results.
    Description
    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)
    Title
    Evaluation of diagnostic precision for the detection of sentinel lymph node detection in epithelial ovarian cancer in early stages according to surgical approach
    Description
    Diagnostic precision defined as global detection rate of sentinel lymph nodes and false negatives rate, stratified by surgical approach
    Time Frame
    Through study completion (an average of 36 months)
    Title
    Evaluation of anatomical distribution of 99mTC draining
    Description
    Detection rate of sentinel lymph node with 99mTC in the group of patients having received the tracer
    Time Frame
    Through study completion (an average of 36 months)
    Title
    Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to morphological characteristics.
    Description
    Detection rate and false negative rate of intraoperative detector gamma probe,stratified by morphologic characteristics.
    Time Frame
    Through study completion (an average of 36 months)
    Title
    Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to pathology results.
    Description
    Detection rate and false negative rate of intraoperative detector gamma probe,stratified by pathology results.
    Time Frame
    Through study completion (an average of 36 months)
    Title
    Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to FIGO stage.
    Description
    Detection rate and false negative rate of intraoperative detector gamma probe,stratified by FIGO stage.
    Time Frame
    Through study completion (an average of 36 months)
    Title
    Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to biochemistry results.
    Description
    Detection rate and false negative rate of intraoperative detector gamma probe,stratified by biochemistry results.
    Time Frame
    Through study completion (an average of 36 months)
    Title
    Evaluation of the performance of intraoperative detector gamma probe in the display of ovarian lymphatic map according to surgical approach.
    Description
    Detection rate and false negative rate of intraoperative detector gamma probe,stratified by surgical approach.
    Time Frame
    Through study completion (an average of 36 months)
    Title
    Evaluation of the performance of intraoperative Near Infrared (NIR) camera in the display of ovarian lymphatic map according to morphological characteristics
    Description
    Detection rate and false negative rate of intraoperative NIR camera,stratified by morphological characteristics
    Time Frame
    Through study completion (an average of 36 months)
    Title
    Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to pathology results.
    Description
    Detection rate and false negative rate of intraoperative NIR camera,stratified by pathology results.
    Time Frame
    Through study completion (an average of 36 months)
    Title
    Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to FIGO stage.
    Description
    Detection rate and false negative rate of intraoperative NIR camera,stratified by FIGO stage.
    Time Frame
    Through study completion (an average of 36 months)
    Title
    Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to biochemistry results.
    Description
    Detection rate and false negative rate of intraoperative NIR camera,stratified by biochemistry results.
    Time Frame
    Through study completion (an average of 36 months)
    Title
    Evaluation of the performance of intraoperative NIR camera in the display of ovarian lymphatic map according to surgical approach.
    Description
    Detection rate and false negative rate of intraoperative NIR camera,stratified by surgical approach.
    Time Frame
    Through study completion (an average of 36 months)
    Title
    Anatomical distribution of sentinel lymph node detected with ICG.
    Description
    Anatomical location of sentinel lymph node according to ICG.
    Time Frame
    Through study completion (an average of 36 months)
    Title
    Anatomical distribution of sentinel lymph node detected with 99mTC albumin nanocolloid.
    Description
    Anatomical location of sentinel lymph node according to 99mTC albumin nanocolloid.
    Time Frame
    Through study completion (an average of 36 months)
    Title
    Comparison of lymph node detection with both tracers.
    Description
    Assessment of concordance of sentinel lymph node anatomical location detected with each tracer.
    Time Frame
    Through study completion (an average of 36 months)
    Title
    Evaluation of ultra-staging in micrometastases detection compared to conventional histology.
    Description
    Pathology ultra-staging evaluation. The following classification will be considered according to the criteria of the American Joint Committee on Cancer (AJCC): Macrometastases: tumor infiltration > 2 mm in maximum diameter. Micrometastases: tumor infiltration between 0.2 and 2 mm in maximum diameter. Isolated tumor cells or isolated cell group (CTA, GCA): clusters of cells smaller than 0.2 mm
    Time Frame
    Through study completion (an average of 36 months)
    Title
    Evaluation of the complications associated with each technique.
    Description
    Chirurgic and post-operative complications, directly or indirectly associated to the use of the tracers.
    Time Frame
    Through study completion (an average of 36 months)

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Laura Burunat, Graduate
    Phone
    932275400
    Ext
    4198
    Email
    burunat@recerca.clinic.cat
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Berta Diaz-Feijoo, Physician
    Organizational Affiliation
    Hospital Clinic of Barcelona
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Aureli Torné, Physician
    Organizational Affiliation
    Hospital Clinic of Barcelona
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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