Fluorescent Indocyanine Green versus Technetium-99m and Blue Dye for Bilateral SENTinel Lymph Node Detection in Stage I-IIA Cervical Cancer (FluoreSENT): protocol for a non-inferiority study.


Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
13 09 2022
Historique:
entrez: 13 9 2022
pubmed: 14 9 2022
medline: 16 9 2022
Statut: epublish

Résumé

Nowadays, two predominant methods for detecting sentinel lymph nodes (SLNs) in cervical cancer are in use. The most conventional method is a combination of a radiotracer, technetium-99m ( We initiated a prospective non-inferiority study with a paired comparison of both SLN methods in a single sample of 101 patients with International Federation of Gynecology and Obstetrics (FIGO) stage IA-IB2 or IIA1 cervical cancer receiving primary surgical treatment. All patients undergo SLN mapping with ICG and NIR fluorescence imaging in adjunct to mapping with The current study is approved by the Medical Ethics Research Committee Utrecht (reference number 21-014). Findings arising from this study will be disseminated in peer-reviewed journals, academic conferences and through patient organisations. NL9011 and EudraCT 2020-005134-15.

Identifiants

pubmed: 36100304
pii: bmjopen-2022-061829
doi: 10.1136/bmjopen-2022-061829
pmc: PMC9472172
doi:

Substances chimiques

Coloring Agents 0
Technetium 7440-26-8
Indocyanine Green IX6J1063HV

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

e061829

Informations de copyright

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: RPZ is a proctor for robot-assisted surgery in gynaecological oncology on behalf of Intuitive Surgical.

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Auteurs

Ilse G T Baeten (IGT)

Department of Gynaecologic Oncology, Division of Imaging and Oncology, University Medical Center Utrecht, Utrecht, Netherlands i.g.t.baeten@umcutrecht.nl.

Jacob P Hoogendam (JP)

Department of Gynaecologic Oncology, Division of Imaging and Oncology, University Medical Center Utrecht, Utrecht, Netherlands.

Arthur J A T Braat (AJAT)

Department of Radiology and Nuclear Medicine, Division of Imaging and Oncology, University Medical Center Utrecht, Utrecht, Netherlands.

Wouter B Veldhuis (WB)

Department of Radiology and Nuclear Medicine, Division of Imaging and Oncology, University Medical Center Utrecht, Utrecht, Netherlands.

Geertruida N Jonges (GN)

Department of Pathology, Division of Laboratory, Pharmacy and Biomedical Genetics, University Medical Center Utrecht, Utrecht, Netherlands.

Ina M Jürgenliemk-Schulz (IM)

Department of Radiotherapy, Division of Imaging and Oncology, University Medical Center Utrecht, Utrecht, Netherlands.

Ronald P Zweemer (RP)

Department of Gynaecologic Oncology, Division of Imaging and Oncology, University Medical Center Utrecht, Utrecht, Netherlands.

Cornelis G Gerestein (CG)

Department of Gynaecologic Oncology, Division of Imaging and Oncology, University Medical Center Utrecht, Utrecht, Netherlands.

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