E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Sentinel lymph node procedure for patients with early-stage cervical cancer |
Schildwachtklierprocedure in patiënten met baarmoederhalskanker |
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E.1.1.1 | Medical condition in easily understood language |
Sentinel lymph node procedure for patients with cervical cancer |
Schildwachtklierprocedure in patiënten met baarmoederhalskanker |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008233 |
E.1.2 | Term | Cervical cancer stage I |
E.1.2 | System Organ Class | 100000004864 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008234 |
E.1.2 | Term | Cervical cancer stage II |
E.1.2 | System Organ Class | 100000004864 |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Intraoperative (fluorescent SLNs) and postoperative (pathological confirmation of SLNs). |
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E.5.2 | 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. |
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E.5.2.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Standard of care for SLN detection with technetium-99m nanocolloid and blue dye |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LVLS |
Laatste bezoek van laatste proefpersoon |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |