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Clinical Trial NCT05573451 (CANNES) for Lymph Node Metastasis, Cervical Cancer is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Comparison of the Accuracy of US, MRI and PET/CT in the Assessment of LNs in Cervical Cancer. (CANNES) 91

Active, not recruiting
Clinical Trial NCT05573451 (CANNES) is an observational study for Lymph Node Metastasis, Cervical Cancer that is active, not recruiting. It started on 20 January 2021 with plans to enroll 91 participants. Led by General University Hospital, Prague, it is expected to complete by 31 December 2024. The latest data from ClinicalTrials.gov was last updated on 25 September 2024.
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 wit...Show More
Detailed Description
CANNES is a single arm, multicenter, prospective imaging trial. Patients referred 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. The preference of imaging method of the first choice depends on the institutional practice. Eligible women meeting all inclusion criteria will b...Show More
Official Title

CANNES (Cervical Cancer Lymph Node Staging): a Prospective, Imaging Study to Compare the Diagnostic Accuracy of Ultrasound, MRI and PET/CT in the Preoperative Assessment of Lymph Nodes in Cervical Cancer.

Conditions
Lymph Node MetastasisCervical Cancer
Other Study IDs
  • CANNES
  • NU21-03-00461
NCT ID Number
NCT05573451
Start Date (Actual)
2021-01-20
Last Update Posted
2024-09-25
Completion Date (Estimated)
2024-12-31
Enrollment (Estimated)
91
Study Type
Observational
Status
Active, not recruiting
Arms / Interventions
Participant Group/ArmIntervention/Treatment
N/A
ultrasound - transvaginal/transrectal + transabdominal
Each patient undergoes at least ultrasound examination and PET-CT.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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)
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
Comparison of overall accuracy of US, PET/CT and DW/MRI in assessment of para-aortic lymph node involvement.
Sensitivity, specificity, PPV, NPV, overall acuracy, AUC, LR+, LR- and p-value will be calculated for each imaging method per patient.
36 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
  • 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

  • Tumor type other than primary cervical carcinomas
  • Second malignant tumor under treatment
  • FIGO stage IV (local spread to rectum or bladder, distant metastases)
General University Hospital, Prague logoGeneral University Hospital, Prague
Charles University, Czech Republic logoCharles University, Czech Republic84 active studies to explore
Study Responsible Party
Filip Fruhauf, Principal Investigator, Principial Investigator, General University Hospital, Prague
No contact data.
1 Study Locations in 1 Countries
General University Hospital, Prague, Czechia