MedTrace Logo

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

NCT05573451 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 91

Last updated 2024-09-25

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIAGNOSTIC_TEST

ultrasound - transvaginal/transrectal + transabdominal

Each patient undergoes at least ultrasound examination and PET-CT.

Sponsors & Collaborators

  • Charles University, Czech Republic

    collaborator OTHER

  • General University Hospital, Prague

    lead OTHER

Principal Investigators

  • Filip Fruhauf · General University Hospital

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-20
Primary Completion
2023-12-31
Completion
2024-12-31

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05573451 on ClinicalTrials.gov