NCT06487767

The Validity of the Use of Imaging in Cervical Cancer Staging

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University of Pretoria · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: —

Summary

The study wil aim to investigate the accuracy of imaging in the staging of women diagnosed with cervical cancer

Detailed description

Patients with cervical cancer undergoing surgery will also undergo PET-CT scan, CT scan, trans-abdominal ultrasound of the pelvis and abdomen to assess pelvic and para-aortic lymph node status, MRI and trans-vaginal ultrasound (TVUS) to assess tumour size and parametrial infiltration. As per the current unit protocol, patients will be assessed clinically for operability. The performance of the different imaging modalities will be measured against the histological status of the parametric and lymph nodes and tumour size as measured by the pathologists. CT, PET-CT, MRI and abdominal ultrasound will be reported as per the usual departmental process. Staff in the radiology department will be blinded for the different imaging modalities performed. TVUS will be performed in the unit by different gynaecological oncologists and fellows and at the time of the investigation will be blinded with regards to clinical findings and the reports of other imaging studies performed. The sensitivity, specificity, positive and negative predictive values will be calculated for the different imaging modalities.

Conditions

• Cervical Cancer Stage, Imaging Modalities

Interventions

Type	Name	Description
OTHER	Surgery	Surgery for operable cervical cancer

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2024-07-05
• Last updated: 2024-07-05

Locations

1 site across 1 country: South Africa