TY - JOUR
T1 - Fluorescent Indocyanine Green versus Technetium-99m and Blue Dye for Bilateral SENTinel Lymph Node Detection in Stage I-IIA Cervical Cancer (FluoreSENT)
T2 - protocol for a non-inferiority study
AU - Baeten, Ilse G T
AU - Hoogendam, Jacob P
AU - Braat, Arthur J A T
AU - Veldhuis, Wouter B
AU - Jonges, Geertruida N
AU - Jürgenliemk-Schulz, Ina M
AU - Zweemer, Ronald P
AU - Gerestein, Cornelis G
N1 - Publisher Copyright:
©
PY - 2022/9/13
Y1 - 2022/9/13
N2 - INTRODUCTION: 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 (
99mTc) and blue dye. More recently, another method for SLN mapping using indocyanine green (ICG) is becoming widely accepted. ICG is a fluorescent dye, visualised intraoperatively with near-infrared (NIR) fluorescence imaging, providing real-time visual navigation. The presumed advantages of ICG over
99mTc, that is, being cheaper, non-radioactive and logistically more attractive, are only valuable if its detection rate proves to be at least non-inferior. Before omitting the well-functioning and evidence-based combined approach of
99mTc and blue dye, we aim to provide prospective evidence on the non-inferiority of ICG with NIR fluorescence imaging.
METHODS AND ANALYSIS: 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
99mTc (including single photon emission computed tomography with X-ray computed tomography (SPECT/CT)) and blue dye. Surgeons start SLN detection with ICG while being blinded for the preoperative outcome of SPECT/CT to avoid biased detection with ICG. Primary endpoint of this study is bilateral SLN detection rate of both methods (ie, detection of at least one SLN in each hemipelvis). Since we compare strategies for SLN mapping that are already applied in current daily practice for different types of cancer, no additional risks or burdens are expected from these study procedures.
ETHICS AND DISSEMINATION: 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.TRIAL REGISTRATION NUMBER: NL9011 and EudraCT 2020-005134-15.
AB - INTRODUCTION: 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 (
99mTc) and blue dye. More recently, another method for SLN mapping using indocyanine green (ICG) is becoming widely accepted. ICG is a fluorescent dye, visualised intraoperatively with near-infrared (NIR) fluorescence imaging, providing real-time visual navigation. The presumed advantages of ICG over
99mTc, that is, being cheaper, non-radioactive and logistically more attractive, are only valuable if its detection rate proves to be at least non-inferior. Before omitting the well-functioning and evidence-based combined approach of
99mTc and blue dye, we aim to provide prospective evidence on the non-inferiority of ICG with NIR fluorescence imaging.
METHODS AND ANALYSIS: 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
99mTc (including single photon emission computed tomography with X-ray computed tomography (SPECT/CT)) and blue dye. Surgeons start SLN detection with ICG while being blinded for the preoperative outcome of SPECT/CT to avoid biased detection with ICG. Primary endpoint of this study is bilateral SLN detection rate of both methods (ie, detection of at least one SLN in each hemipelvis). Since we compare strategies for SLN mapping that are already applied in current daily practice for different types of cancer, no additional risks or burdens are expected from these study procedures.
ETHICS AND DISSEMINATION: 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.TRIAL REGISTRATION NUMBER: NL9011 and EudraCT 2020-005134-15.
KW - Coloring Agents
KW - Female
KW - Humans
KW - Indocyanine Green
KW - Lymphadenopathy
KW - Prospective Studies
KW - Sentinel Lymph Node Biopsy/methods
KW - Sentinel Lymph Node/diagnostic imaging
KW - Technetium
KW - Uterine Cervical Neoplasms/diagnostic imaging
KW - Nuclear radiology
KW - Gynaecological oncology
KW - ONCOLOGY
KW - Diagnostic radiology
KW - GYNAECOLOGY
UR - http://www.scopus.com/inward/record.url?scp=85137777720&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2022-061829
DO - 10.1136/bmjopen-2022-061829
M3 - Article
C2 - 36100304
SN - 2044-6055
VL - 12
SP - 1
EP - 8
JO - BMJ Open
JF - BMJ Open
IS - 9
M1 - e061829
ER -