Apparent Diffusion Coefficient as a Prognostic Biomarker in Cervical Cancer

Diffusion-weighted MRI at 3T Using an Endovaginal Coil: Evaluating the Prognostic Value of the Apparent Diffusion Coefficient Distribution in Stage 1 Cervical Tumours

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).

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Procedure: Magnetic Resonance Imaging using an endovaginal receiver coil

• Study Type: Observational
• Enrollment (Actual): 236

Contacts and Locations

Study Locations

• United Kingdom
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • The Institute of Cancer Research and Royal Marsden NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Primary Care Clinic

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Ferromagnetic metal implants
• claustrophobia (MRI incompatibility)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cervical Cancer; Patients with presumed early cervical cancer being considered for curative surgery	Procedure: Magnetic Resonance Imaging using an endovaginal receiver coil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establish ADC values associated with poor prognosis tumours	The centile measures of the ADC values will be summarised using means and standard deviations if the data are normally distributed and medians and ranges if the data are non-normally distributed. The unpaired t-test will be used to analyse normally distributed data and the Mann Whitney U test for non-parametric data. Point estimates for the differences between centile ADC values and other summary measures for tumour type, grade and presence or absence of lymphovascular space invasion will be derived and 95% confidence intervals attached where appropriate. The Bonferroni correction method will be used to adjust significance levels for multiple comparisons. The key clinical question is whether or not the imaging can differentiate poor prognosis tumours from good prognosis ones from the histogram metrics.	Duration of study, 2-3 years

Collaborators and Investigators

• Sponsor: Institute of Cancer Research, United Kingdom
• Collaborators: Cancer Research UK

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2013
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: August 29, 2013
• First Submitted That Met QC Criteria: September 7, 2013
• First Posted (Estimate): September 9, 2013

Study Record Updates

• Last Update Posted (Actual): January 28, 2020
• Last Update Submitted That Met QC Criteria: January 27, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Magnetic Resonance Imaging
• Other Study ID Numbers: 13/EE/0198 CCR3938