Ovarian Epithelial Cancer Clinical Trial
— Melisa-IIOfficial 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 to evaluate the diagnostic precision of ICG and 99mTc nanocolloid albumin in sentinel lymph node detection in early ovarian epithelial cancer.
Status | Not yet recruiting |
Enrollment | 62 |
Est. completion date | October 2026 |
Est. primary completion date | October 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Fundacion Clinic per a la Recerca Biomédica |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Through study completion (an average of 36 months) | |
Secondary | 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. | Through study completion (an average of 36 months) | |
Secondary | 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 | Through study completion (an average of 36 months) | |
Secondary | 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 | Through study completion (an average of 36 months) | |
Secondary | 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 | Through study completion (an average of 36 months) | |
Secondary | 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 | Through study completion (an average of 36 months) | |
Secondary | Evaluation of anatomical distribution of 99mTC draining | Detection rate of sentinel lymph node with 99mTC in the group of patients having received the tracer | Through study completion (an average of 36 months) | |
Secondary | 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. | Through study completion (an average of 36 months) | |
Secondary | 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. | Through study completion (an average of 36 months) | |
Secondary | 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. | Through study completion (an average of 36 months) | |
Secondary | 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. | Through study completion (an average of 36 months) | |
Secondary | 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. | Through study completion (an average of 36 months) | |
Secondary | 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 | Through study completion (an average of 36 months) | |
Secondary | 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. | Through study completion (an average of 36 months) | |
Secondary | 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. | Through study completion (an average of 36 months) | |
Secondary | 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. | Through study completion (an average of 36 months) | |
Secondary | 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. | Through study completion (an average of 36 months) | |
Secondary | Anatomical distribution of sentinel lymph node detected with ICG. | Anatomical location of sentinel lymph node according to ICG. | Through study completion (an average of 36 months) | |
Secondary | Anatomical distribution of sentinel lymph node detected with 99mTC albumin nanocolloid. | Anatomical location of sentinel lymph node according to 99mTC albumin nanocolloid. | Through study completion (an average of 36 months) | |
Secondary | Comparison of lymph node detection with both tracers. | Assessment of concordance of sentinel lymph node anatomical location detected with each tracer. | Through study completion (an average of 36 months) | |
Secondary | 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 |
Through study completion (an average of 36 months) | |
Secondary | Evaluation of the complications associated with each technique. | Chirurgic and post-operative complications, directly or indirectly associated to the use of the tracers. | Through study completion (an average of 36 months) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02096783 -
Scripted Sexual Health Informational Intervention in Improving Sexual Function in Patients With Gynecologic Cancer
|
N/A | |
Active, not recruiting |
NCT01456065 -
Safety of Active Immunotherapy in Subjects With Ovarian Cancer
|
Phase 1 | |
Recruiting |
NCT06404671 -
Timing of Surgery After Neoadjuvant Chemotherapy for Advanced Ovarian Cancer
|
N/A | |
Recruiting |
NCT05001282 -
A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRĪ±)
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT03220932 -
Cytoreductive Surgery and HIPEC in First or Secondary Platinum-resistant Recurrent Ovarian Epithelial Cancer
|
Phase 3 | |
Completed |
NCT02039388 -
Lavage of the Uterine Cavity for the Diagnosis of Serous Tubal Intraepithelial Carcinoma
|
N/A | |
Completed |
NCT02107950 -
Phase II Study DCVAC/OvCa Plus Carboplatin Gemcitabine Relapsed Platinum (Pt)-Sensitive Epithelial Ovarian Carcinoma
|
Phase 2 | |
Completed |
NCT02107937 -
Phase II Study DCVAC/OvCa Added to First Line Carboplatin and Paclitaxel Newly Diagnosed Epithelial Ovarian Carcinoma
|
Phase 2 | |
Completed |
NCT01806350 -
Pelvic Floor Muscle Training in Treating Urinary Incontinence in Gynecologic Cancer Survivors
|
N/A | |
Recruiting |
NCT03349463 -
Evaluation of Fluciclovine Uptake in Patients With Cervical, Ovarian Epithelial or Endometrial Cancers.
|
Phase 4 | |
Completed |
NCT04823871 -
Early Detection of High Grade Ovarian Cancer Using Uterine Lavage EHUD Study and Duplex Sequencing
|
N/A | |
Completed |
NCT02518256 -
Lavage of the Uterine Cavity for the Diagnosis of Ovarian and Tubal Carcinoma - Study of Sensitivity and Specificity
|
N/A | |
Active, not recruiting |
NCT03078400 -
Safety and Efficacy Study of Daily SPL-108 Injections In Conjunction With Paclitaxel in Women With Ovarian Cancer
|
Phase 1 | |
Not yet recruiting |
NCT02435186 -
p53 Gene in Treatment of Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer
|
Phase 2 | |
Completed |
NCT02489903 -
RRx-001 in Lung Cancer, Ovarian Cancer and Neuroendocrine Tumors Prior to Re-administration of Platinum Based Doublet Regimens (QUADRUPLE THREAT)
|
Phase 2 | |
Recruiting |
NCT04029909 -
A Clinical Study of Gimatecan in Advanced Ovarian Epithelial Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer
|
Phase 1 | |
Recruiting |
NCT05498597 -
AMT-151 in Patients With Selected Advanced Solid Tumours
|
Phase 1 | |
Suspended |
NCT02742428 -
Preoperative Ascites Drainage Versus Standard Care for Patients With Advanced Ovarian Cancer
|
N/A | |
Active, not recruiting |
NCT02981901 -
Optimisation of Disease Management in Patients With Epithelial Ovarian Cancer in France
|
||
Completed |
NCT02062697 -
Lavage of the Uterine Cavity for the Diagnosis of Ovarian and Tubal Carcinoma and Their Premalignant Changes.
|
N/A |