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NCT Number: NCT06487767

The Validity of the Use of Imaging in Cervical Cancer Staging

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

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women diagnosed with cervical cancer Able and willing to provide informed consent

Exclusion criteria

Previously treated for cervical cancer Unable to provide informed consent Patients with contra-indications to undergo surgical treatment

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Treatment and study plan

SURGERY

Other

Surgery for operable cervical cancer

Primary outcomes

  1. Sensitivity and specificity

    Time frame: 2 years

    Metrics of imaging

Study contacts

Contact information is provided by the study sponsor or research team.

Edwin F Mnisi, MMed (O&G)

CONTACT

[email protected]

+27766129797

Leon C Snyman, PhD

CONTACT

[email protected]

+27834621818

Sponsors and collaborators

Lead sponsor

University of Pretoria

Other

Collaborators

  • Dr Edwin Mnisi
  • Prof Mike Sathekge
  • Prof N Khan

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 5, 2024
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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