Comparison of the Accuracy of US, MRI and PET/CT in the Assessment of LNs in Cervical Cancer.

Lymph node involvement is the most important negative prognostic factor in cervical cancer. Reliable preoperative lymph node assessment is of utmost importance to tailor the treatment. According to the current European guidelines local extent of the disease can be assessed by magnetic resonance imaging (MRI) or by ultrasound (US), if performed by properly trained sonographer. Positron emission tomography combined with computed tomography (PET/CT) is used as a reference standard for preoperative evaluation of lymph nodes. Another technique to assess nodes combining morphological and functional characteristics is diffusion-weighted MRI (DW/MRI). While US is considered the adequate alternative to MRI in local staging of cervical cancer, there is no relevant evidence of diagnostic performace of US in nodal assessment. However, retrospective analysis of diagnostic accuracy of US from our site brought promising results. Furthermore, there are no trials prospectively investigating these three imaging methods in the same study population. The CANNES study is a prospective multicenter trial comparing diagnostic accuracy of US, PET/CT and DW/MRI in preoperative assessment of pelvic lymph nodes in cervical cancer. The study is designed to establish new standard in preoperative assessment of pelvic lymph nodes in patients with cervical cancer. Ninety-one patients will be enrolled into the study within 36 months and each of them will undergo all three imaging methods. To avoid a bias all imaging examinations will be conducted independently and blinded among sonographers, radiologists and nuclear medicine physicians. By contrast, each surgeon will have all reports from imaging available before procedure to be used as a navigation. Surgical procedures will include sentinel lymph node biopsy, debulking/sampling or systematic dissection of pelvic nodes following current European guidelines.

Sex

Female

Minimum age

18 Years

Maximum age

80 Years

Inclusion Criteria:

* Histopathologically verified cervical cancer
* FIGO stage IA1 L1 (lymphovascular space involvement) - IIIC2
* Patient eligible for surgery (PLND, sampling or debulking of LNs, SLNB)
* PET/CT scan not contraindicated
* 18 \> Age \< 80
* Eastern Cooperative Oncology Group (ECOG) performance status grade \< 3
* Non-pregnant patient
* Informed consent signed

Exclusion Criteria:

* Tumor type other than primary cervical carcinomas
* Second malignant tumor under treatment
* FIGO stage IV (local spread to rectum or bladder, distant metastases)