RT Journal Article
SR Electronic
T1 TP002/#1431  Multicentric international imaging study to compare the dagnostic accuracy of ultrasound, DW/MRI and PET/CT in preoperative assessment of lymph node status in cervical cancer (CANNES)
JF International Journal of Gynecologic Cancer
JO Int J Gynecol Cancer
FD BMJ Publishing Group Ltd
SP A246
OP A246
DO 10.1136/ijgc-2023-IGCS.465
VO 33
IS Suppl 4
A1 Fruhauf, Filip
A1 Fischerova, Daniela
A1 Kocian, Roman
A1 Bizzarri, Nicolò
A1 Peréz, Reyes Oliver
A1 Cibula, David
YR 2023
UL http://ijgc.bmj.com/content/33/Suppl_4/A246.1.abstract
AB Introduction The objective of this study is to compare the overall accuracy of US, PET/CT and DW/MRI in preoperative assessment of lymph nodes (LNs) in cervical cancer. Primary end-point is the overall accuracy of imaging in detection of pelvic LN macrometastases and to prove non-inferioriy of US to other methods. Main secondary end-points include overall accuracy in detection of pelvic macro- and/or micrometastases (pN1) and paraaortic LN involvement.Methods All patients with histopathologically verified cervical cancer and eligible for surgery (minimally systematic PLND, PLN sampling/debulking or SLN biopsy) will be enrolled. Key exclusion criteria include FIGO stage IVA and IVB. Each patient will undergo three imaging methods performed by dedicated operators following standardized protocols within 6 weeks before surgery. Imaging will be conducted independently and blinded but surgeons will have all reports available as navigation. The surgical procedures will be done in line with institutional guidelines but all radiologically positive LNs must be removed. The final histopathological examination will be a primary reference standard and diagnostic performance of imaging will be assessed per patient and per site. If LNs are preoperatively classified as certainly or probably infiltrated but histopathological examination including ultrastaging is negative, imaging will be repeated after surgery. If radiologically positive LNs persist, it will be considered a secondary reference standard.Current Trial Status The aimed number of patients is 91. There are 3 contributing centers (Prague, Rome, Madrid). The first patient was enrolled in January/2021 and the last one is expected in December/2023. The final analysis with outcomes is planned in 2024.