To hear about similar clinical trials, please enter your email below
Trial Title:
Sentinel Node Detection With Technetium-99m Albumin Nanocolloid and ICG in Patients With Epithelial Ovarian Cancer
NCT ID:
NCT05937620
Condition:
Ovarian Epithelial Cancer
Conditions: Official terms:
Carcinoma, Ovarian Epithelial
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
99mTC nanocolloid albumin injection
Description:
All patients will receive an injection of both tracers in order to detect the sentinel
lymph node
Arm group label:
Interventional arm
Intervention type:
Diagnostic Test
Intervention name:
ICG injection
Description:
All patients will receive an injection of both tracers in order to detect the sentinel
lymph node
Arm group label:
Interventional arm
Summary:
Study to evaluate the diagnostic precision of ICG and 99mTc nanocolloid albumin in
sentinel lymph node detection in early ovarian epithelial cancer.
Criteria for 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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
November 2023
Completion date:
October 2026
Lead sponsor:
Agency:
Fundacion Clinic per a la Recerca Biomédica
Agency class:
Other
Source:
Fundacion Clinic per a la Recerca Biomédica
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05937620
