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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitair Medisch Centrum Utrecht

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

26 Apr 2021 → 7 Aug 2025

Decision date (initial)

2024-05-10

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

UMC Utrecht

External identifiers

EU CT number

2024-511966-36-00

EudraCT number

2020-005134-15

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

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.

Secondary objectives 1

1. To assess the overall detection rate (defined as the proportion of patients in which at least one SLN is detected); - To assess sensitivity and false negative rate (FNR; defined as the proportion of patients with tumour-negative SLNs and tumour-positive non-SLNs divided by the total number of patients receiving SLN procedure) 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); - To evaluate the number of SLNs identified with NIR fluorescence, radioactivity and blue staining. In addition, to evaluate the correlation (concordance) between NIR fluorescent (ICG positive), radioactive (99mTc positive) and blue stained SLNs, in terms of anatomical location of the detected SLN; - Adverse events of ICG, 99mTc and/or blue dye; - The time to complete SLN detection with ICG versus 99mTc + blue dye (including the time to detect separate SLNs); - To perform a cost-effectiveness comparison of ICG versus 99mTc and blue dye SLN detection; - To assess patient satisfaction with the oncological care and procedure; - To evaluate the usability of fluorescence imaging (questionnaire filled in by the surgeons).

Conditions and MedDRA coding

cervical cancer stage I-IIA

Regulatory references

Scientific advice from competent authorities

Central Committee On Research Involving Human Subjects

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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 guidelines39); - Radical surgery is planned including a SLN procedure.

Exclusion criteria 1

1. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Bilateral detection rate of SLNs with ICG and NIR fluorescence imaging versus 99mTc with blue dye. A SLN is defined as the first lymph node(s) of each hemipelvis to receive afferent lymphatic drainage from the primary cervical tumour, identified by either ICG, gamma radiation using 99mTc or blue dye. Bilateral detection rate of a tracer/modality is defined as number of patients detected with at least one SLN in each hemipelvis divided by the total number of patients undergoing SLN procedure.

Secondary endpoints 3

1. Overall detection rate (defined as the proportion of patients in which at least one SLN is detected) - Sensitivity and FNR (defined as the proportion of patients with tumour-negative SLNs and tumour-positive non-SLNs divided by the total number of patients with lymph node metastasis) of ICG and 99mTc and blue dye, with PLND as gold standard to confirm tumour positive non-SLNs (part of current standard-of-care).
2. The number of SLNs identified with NIR fluorescence, radioactivity and blue staining. - Concordance between ICG and 99mTc with blue dye in terms of SLN localisation, by strictly reporting all localisations and whether positive with ICG, SPECT-CT (preoperatively), 99mTc,or blue dye, or a combination of these. - Adverse events of ICG, 99mTc and/or blue dye; - The time to complete SLN detection with ICG versus 99mTc + blue dye
3. Cost-effectiveness, defined as the costs of the procedure versus the yielded bilateral detection rate of the procedure; - Patient satisfaction with the oncological care and procedure measured with the validated EORTC IN-PATSAT32 questionnaire; - Surgical evaluation of fluorescent imaging (usability) measured with two short questionnaires tailored for the surgeons.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitair Medisch Centrum Utrecht

Sponsor organisation

Universitair Medisch Centrum Utrecht

Address

Heidelberglaan 100

City

Utrecht

Postcode

3584 CX

Country

Netherlands

Scientific contact point

Organisation

Universitair Medisch Centrum Utrecht

Contact name

C.G. Gerestein

Public contact point

Organisation

Universitair Medisch Centrum Utrecht

Contact name

C.G. Gerestein

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications