Apparent Diffusion Coefficient as a Prognostic Biomarker in Cervical Cancer

NCT01937533 | Completed

• 1 other identifier: 13/EE/0198 CCR3938
• Study Type: observational
• Target: 236
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to develop the technique of Diffusion-Weighted Magnetic Resonance Imaging(DW-MRI)for the assessment of stage 1 cervical cancers. An endovaginal receiver coil has been designed and developed at the Institute of Cancer Research and Royal Marsden NHS Foundation Trust for use at high field strengths(3T). This will be used to evaluate if DW-MRI at 3T can be used to differentiate different histological characteristics within whole tumours and so determine if the technique could be of prognostic value. The study hypothesis is that this technique will be able to differentiate tumours with histological features known to be associated with poor prognosis (tumour type, grade and lymphovascular space invasion).

Conditions

Cancer

Keywords

Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• To obtain histogram metrics(centiles, skew, kurtosis, entropy) for cervical cancer and compare them between histologically poor prognosis and good prognosis groups.

  Pixel by pixel analysis of ADC from tumour regions of interest will be used to derive histograms and the 10th, 25th, 50th, 75th and 90th centile values and histogram skew, kurtosis and entropy values for each tumour will be recorded. The number of regions will vary with tumour volume in each patient, given the mean size of lesions in patients studied in a pilot set, it is envisaged that we will analyse 1-5 regions of interest in each tumour. The data will be analysed separately by 2 observers who will be blinded to the histopathological characteristics and assuming good inter-observer agreement, an average of their results will be used for data analysis. The difference in mean centile ADC values of the distribution and the skewness, kurtosis and entropy values between squamous vs. adenocarcinoma, well/moderately differentiated vs. poorly differentiated tumour regions and the absence vs. the presence of lymphovascular space invasion in that region will be determined.

  1-2 months post imaging

Secondary Outcomes (1)

• Establish ADC values associated with poor prognosis tumours

  Duration of study, 2-3 years

Study Arms (1)

Cervical Cancer

Patients with presumed early cervical cancer being considered for curative surgery

Procedure: Magnetic Resonance Imaging using an endovaginal receiver coil

Interventions

Magnetic Resonance Imaging using an endovaginal receiver coil PROCEDURE

Cervical Cancer

Eligibility Criteria

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

Study Population

Primary Care Clinic

You may qualify if:

• All patients with presumed early stage cervical cancer being considered for curative surgery

You may not qualify if:

• Ferromagnetic metal implants
• claustrophobia (MRI incompatibility)

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead
• Cancer Research UK: collaborator

Study Sites (1)

The Institute of Cancer Research and Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Nandita deSouza, Professor

  ICR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Translational Imaging

Study Record Dates

• First Submitted: August 29, 2013
• First Posted: September 9, 2013
• Study Start: October 2, 2013
• Primary Completion: May 1, 2019
• Study Completion: May 31, 2019
• Last Updated: January 28, 2020

Record last verified: 2020-01

Locations

GB (1)