Sentinel lymph node procedure for patients with early-stage cervical cancer MedDRA version: 21.1 Level: LLT Classification code 10008233 Term: Cervical cancer stage I System Organ Class: 100000004864 MedDRA version: 21.1 Level: LLT Classification code 10008234 Term: Cervical cancer stage II System Organ Class: 100000004864
Conditions
Interventions
Trade Name: VERDYE 25 mg (indocyanine green)
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Indocyanine green
CAS Number: 3599-32-4
Other descriptive name: IND
Sponsors
University Medical Center Utrecht
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Age =18 years and able to provide informed consent -A histopathologically proven primary malignancy of the cervix uteri -FIGO stage IA1-IB2 or IIA1 (according to the FIGO 2018 guidelines) -Radical surgery is planned including a SLN procedure Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 101 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Pregnancy or current breastfeeding (confirmation by a pregnancy test is the current standard of care) -Renal insufficiency stage 3 or 4 -Prior allergic reaction to ICG, 99mTc or patent blue -Prior severe allergic reaction to iodine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the bilateral sentinel lymph node (SLN) detection rate of intraoperative indocyanine green (ICG) with near-infrared fluoresence imaging compared to the current standard of care of technetium-99m nanocolloid (99mTc) and blue dye in patients with early-stage cervical cancer.;Secondary Objective: 1. To assess the overall SLN detection rate; 2. To assess sensitivity and false negative rate of ICG and 99mTc and blue dye, with pelvic lymph node dissection (PLND) as gold standard to confirm tumour positive lymph nodes (part of current standard-of-care); 3. To evaluate the number of SLNs identified with NIR fluorescence, radioactivity and blue staining. In addition, to evaluate the correlation (concordance) between NIR fluorescent, radioactive and blue stained SLNs, in terms of anatomical location of the detected SLN; 4. To evaluate adverse events of ICG, 99mTc and/or blue dye; 5. To assess the time to complete SLN detection with ICG versus 99mTc + blue dye (including the time to detect separate SLNs); 6. To perform a cost-effectiveness comparison of ICG versus 99mTc and blue dye SLN detection; 7. To assess patient satisfaction with the oncological care and procedure; 8. To evaluate the usability of fluorescence imaging (questionnaire filled in by the surgeons).;Primary end point(s): The intraoperative bilateral SLN detection with ICG versus a combination of 99mTc and blue dye in patients with cervical cancer undergoing a SLN procedure.;Timepoint(s) of evaluation of this end point: Intraoperative (fluorescent SLNs) and postoperative (pathological confirmation of SLNs). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Overall SLN detection rate; 2. Sensitivity and false negative rate of ICG and 99mTc and blue dye, with pelvic lymph node dissection (PLND) as gold standard to confirm tumour positive lymph nodes (part of current standard-of-care); 3. The number of SLNs identified with NIR fluorescence, radioactivity and blue staining. 4. The correlation (concordance) between NIR fluorescent, radioactive and blue stained SLNs, in terms of anatomical location of the detected SLN; 5. Adverse events of ICG, 99mTc and/or blue dye; 6. The time to complete SLN detection with ICG versus 99mTc + blue dye (including the time to detect separate SLNs); 7. Cost-effectiveness comparison of ICG versus 99mTc and blue dye SLN detection; 8. Patient satisfaction with the oncological care and procedure; 9. Surgical evaluation of the usability of fluorescence imaging measured with questionnaires.;Timepoint(s) of evaluation of this end point: 1. Intraoperative measurements, postoperative analysis 2. Postoperative pathological assessment 3. Intraoperative measurements, postoperative analysis 4. Intraoperative measurements, postoperative analysis 5. Intraoperative and postoperative observations 6. Intraoperative measurements 7. Postoperative analysis 8. Postoperative analysis with use of questionnaires 9. Postoperative analysis with use of questionnaires for surgeons | — |
Countries
Netherlands
Contacts
Public ContactResearcher
University Medical Center Utrecht
Outcome results
None listed