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

NCT05573451 | Active Not Recruiting DMC

• 1 other identifier: NU21-03-00461
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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

Lymph Node Metastasis; Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Primary endpoint is comparison of the overall accuracy of ultrasound, PET/CT and DW/MRI in preoperative detection of pelvic lymph node macrometastases.

  Sensitivity, specificity, PPV, NPV, overall acuracy, AUC, LR+, LR- and p-value will be calculated for each imaging method per patient and per site (separately right and left pelvic lymph nodes).

  36 months

Secondary Outcomes (2)

• Comparison of overall accuracy of US, PET/CT and DW/MRI in detection of pelvic lymph node involvement according to the TNM and FIGO classification (including both macrometastases and micrometastases)

  36 months

• Comparison of overall accuracy of US, PET/CT and DW/MRI in assessment of para-aortic lymph node involvement.

  36 months

Interventions

ultrasound - transvaginal/transrectal + transabdominal DIAGNOSTIC_TEST

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

Also known as: PET-CT (positron emission tomography - computed tomography), DW-MRI (diffusion weighted magnetic resonance imaging)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with histopathologically confirmed cervical cancer will be clinically examined. As standard of care one of imaging method will be performed in preoperative local work-up - ultrasound or DW/MRI. Per protocol PET/CT will be added. Surgery (laparoscopy, laparotomy or robotic surgery) should always be performed within 6 weeks after the first imaging method. Surgical procedure must include SLNB or sampling/debulking of suspicious/enlarged pelvic lymph nodes (± inframesenteric PALND) or systematic PLND. Surgeons will have all reports from ultrasound, PET/CT and DW/MRI available before surgery to be used as a navigation.

You may qualify if:

• 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
• \> Age \< 80
• Eastern Cooperative Oncology Group (ECOG) performance status grade \< 3
• Non-pregnant patient
• Informed consent signed

You may not qualify if:

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

Sponsors & Collaborators

• General University Hospital, Prague: lead
• Charles University, Czech Republic: collaborator

Study Sites (1)

General University Hospital

Prague, Czechia

Location

MeSH Terms

Conditions

Lymphatic Metastasis; Uterine Cervical Neoplasms

Interventions

Positron Emission Tomography Computed Tomography; Diffusion Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope; Magnetic Resonance Imaging

Study Officials

• Filip Fruhauf

  General University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principial Investigator

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 10, 2022
• Study Start: January 20, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)