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The Validity of the Use of Imaging in Cervical Cancer Staging

U

University of Pretoria (UP)

Status

Not yet enrolling

Conditions

Cervical Cancer Stage, Imaging Modalities

Treatments

Other: Surgery

Study type

Observational

Funder types

Other

Identifiers

NCT06487767
704/2023

Details and patient eligibility

About

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

Full 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.

Enrollment

100 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Edwin F Mnisi, MMed (O&G); Leon C Snyman, PhD

Data sourced from clinicaltrials.gov

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