This study has been transitioned to CTIS with ID 2024-511966-36-00 check the CTIS register for the current data. To evaluate the bilateral SLN detection rate of intraoperative ICG with NIR fluorescence imaging compared to the current standard of…
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint of this study is bilateral SLN detection rate of the
different modalities (i.e. detection of at least one SLN in each hemipelvis).
Bilateral detection rate is defined as the proportion of patients with at least
one SLN detected in each hemipelvis.
Secondary outcome
Secondary endpoints include overall SLN detection rate (i.e. detection of at
least one SLN), diagnostic accuracy in terms of tumour positivity of the
different modalities (sensitivity and false negatives; defined as patients with
tumour-negative SLNs and tumour-positive non-SLNs), with pelvic lymph node
dissection (PLND) as gold standard to confirm tumour positive lymph nodes (part
of current standard-of-care), the number of SLNs detected, concordance of SLN
localisation with different modalities, cost-effectiveness in terms of costs
related to the percentage increase in bilateral detection rate, patient
satisfaction with the provided care, and usability of fluorescence guided
surgery.
Background summary
We hypothesize intraoperative indocyanine green (ICG) with near-infrared (NIR)
fluorescence imaging provides non-inferior bilateral detection rates of
sentinel lymph nodes (SLNs) in early stage cervical cancer compared with the
current standard of care, Technetium-99m nanocolloid (99mTc) with preoperative
SPECT-CT in combination with intraoperative blue dye. In daily practice,
switching to ICG offers advantages over the use of 99mTc and blue dye; ICG is
cheaper, non-radioactive, logistically more attractive, and leads to less
burden on the patient (shorter admission, injection under anaesthesia,
potentially less morbidity).
Study objective
This study has been transitioned to CTIS with ID 2024-511966-36-00 check the CTIS register for the current data.
To evaluate the bilateral SLN detection rate of intraoperative ICG with NIR
fluorescence imaging compared to the current standard of care of 99mTc (with
preoperative SPECT/CT) and blue dye.
Study design
We plan a cross-sectional, monocentre, non-inferiority study with a paired
comparison of both SLN modalities in a single sample of patients. Thus, all
patients undergo mapping with ICG and NIR fluorescence imaging followed by
mapping with 99mTc and blue dye. The surgeons will be blinded for the
pre-operative outcome of SPECT-CT to avoid biased detection with ICG.
Intervention
ICG with NIR fluorescence imaging.
Study burden and risks
As we compare strategies for SLN procedure that are already applied in current
daily practice (99mTc with blue dye) or on large scale in research setting for
cervical cancer (ICG), no additional risks or burdens are expected from these
interventions. Since ICG with NIR fluorescence imaging is used in adjunct to
the standard procedure, the total operation time might be slightly longer
(estimated at 15 minutes). The extra time will only be a small fraction of the
total duration of the operation (240 minutes) and will therefore entail only
minimal risks of prolonged anaesthesia. In very rare cases an allergic reaction
to ICG has been reported (< 1/10.000 cases). In order to minimize this risk,
patients with an severe allergy for iodine and those with a renal insufficiency
are excluded from this study.
Patients receive an additional questionnaire (EORTC IN-PATSAT32) regarding
patients* satisfaction with the oncological care and services.1 This
questionnaire is validated and the results can help us to place the outcome
measures in context of the patients* experience. No additional blood samples,
site visits or physical examinations are needed during this study.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
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
-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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2024-511966-36-00 |
| EudraCT | EUCTR2020-005134-15-NL |
| CCMO | NL75722.041.20 |
| Other | NL9011 |