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NCT05573451: CANNES

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

Active, enrolled Last updated 25 September 2024
What this trial tests

trial testing ultrasound - transvaginal/transrectal + transabdominal in Lymph Node Metastasis in 91 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
20 January 2021
Primary endpoint
31 December 2023
31 December 2024

Quick facts

Lead sponsorGeneral University Hospital, Prague
StatusActive, enrolled
Study typeOBSERVATIONAL
Enrollment91
Start date20 January 2021
Primary completion31 December 2023
Estimated completion31 December 2024
Sites1 location across Czechia

Drugs / interventions tested

Conditions studied

Sponsor

General University Hospital, Prague

Who can join

Adults 18 to 80, female only, with Lymph Node Metastasis or Cervical Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Staging by imaging in gynecologic cancer and the role of ultrasound: an update of European joint consensus statements.
    Fischerova D, Smet C, Scovazzi U, Sousa DN, et al · · 2024 · cited 23× · PMID 38438175 · DOI 10.1136/ijgc-2023-004609
  2. Prospective comparison of diagnostic accuracy of ultrasound, PET/CT and DW-MRI for preoperative assessment of pelvic lymph nodes in cervical cancer patients: results of the CANNES trial.
    Frühauf F, Fischerová D, Moro F, Kocián R, et al · · 2026 · PMID 42178785 · DOI 10.1002/uog.70241

Verify or expand the search:

Other recruiting trials for Lymph Node Metastasis

Currently open trials in the same condition.

Other General University Hospital, Prague trials

Trials by the same sponsor.

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Data sources for this page

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