The bilateral sentinel node detection rate of fluorescent indocyanine green compared to 99mTc and blue dye in the sentinel node procedure in stage I-IIA cervical cancer

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28788

Enrollment

101

Registered

2020-10-30

Start date

2021-03-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical cancer

Interventions

SLN procedure with NIR fluorescence imaging after peritumoral injection of ICG (5mg) in adjunct to the current standard of care

Eligibility

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

Exclusion criteria

Exclusion criteria: - Pregnancy or current breastfeeding (confirmation by a pregnancy test is the current standard of care), because of the unknown risks of ICG on - Renal insufficiency stage 3 or 4, because of the increased risk of anaphylactic reaction - Prior allergic reaction to ICG, 99mTc or patent blue - Prior severe allergic reaction to iodine

Design outcomes

Primary

Measure	Time frame
The intraoperative bilateral SLN detection with ICG versus a combination of 99mTc and blue dye in patients with cervical cancer undergoing a SLN procedure.	—

Secondary

Measure	Time frame
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 (IN-PATSAT32 questionnaire); 9. Surgical evaluation of the usability of fluorescence imaging measured with questionnaires.	—

Measure

Time frame

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 (IN-PATSAT32 questionnaire); 9. Surgical evaluation of the usability of fluorescence imaging measured with questionnaires.

—

Contacts

Public ContactIlse Baeten

UMC Utrecht

i.g.t.baeten@umcutrecht.nl+31 88 75 530 68

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)