CancerNCT01937533
Apparent Diffusion Coefficient as a Prognostic Biomarker in Cervical Cancer
An observational study of Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Cancer
- What is being tested?
- Magnetic Resonance Imaging using an endovaginal receiver coil
- Type of treatment
- Surgery or procedure
- How many people
- 236 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Oct 2013to 31 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Primary Care Clinic
Who may be able to join
- All patients with presumed early stage cervical cancer being considered for curative surgery
Who cannot join
- Ferromagnetic metal implants
- claustrophobia (MRI incompatibility)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Institute of Cancer Research and Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
About this study
Official title: 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).
- Conditions
- Cancer
- Being tested
- Magnetic Resonance Imaging using an endovaginal receiver coil
- Keywords
- Magnetic Resonance Imaging
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging using an endovaginal receiver coilProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Cervical Cancer | Patients with presumed early cervical cancer being considered for curative surgery Receives: Procedure: Magnetic Resonance Imaging using an endovaginal receiver coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-2 months post imaging
Secondary outcomes (1)
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.
Measured: Duration of study, 2-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2013 (estimated)
- Study start2 Oct 2013
- Primary completionMay 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Institute of Cancer Research, United KingdomThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK
- Responsible party
- Principal investigator, Nandita deSouza, Institute of Cancer Research, United Kingdom
- Investigators
- Nandita deSouza, Professor, Principal investigator, ICR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01937533
- Sponsor's protocol ID
- 13/EE/0198 CCR3938
- Status last verified
- Jan 2020
- First submitted
- 29 Aug 2013
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diffusion-weighted MRI at 3T Using an Endovaginal Coil: Evaluating the Prognostic Value of the Apparent Diffusion Coefficient Distribution in Stage 1 Cervical Tumours
- ClinicalTrials.gov ID
- NCT01937533
- Acronym / sponsor ID
- 13/EE/0198 CCR3938
- Conditions
- Cancer
- Keywords
- Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Collaborators
- Cancer Research UK
- Study start
- 2 Oct 2013 (actual)
- Primary completion
- May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 9 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervical Cancer | – | Procedure: Magnetic Resonance Imaging using an endovaginal receiver coilPatients with presumed early cervical cancer being considered for curative surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinic
Key inclusion criteria (1 listed)
- All patients with presumed early stage cervical cancer being considered for curative surgery
Key exclusion criteria (2 listed)
- Ferromagnetic metal implants
- claustrophobia (MRI incompatibility)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Imaging using an endovaginal receiver coil | Procedure or surgery | Cervical Cancer |
Primary outcome
To obtain histogram metrics(centiles, skew, kurtosis, entropy) for cervical cancer and compare them between histologically poor prognosis and good prognosis groups.
Time frame: 1-2 months post imaging
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 secondary outcome
Establish ADC values associated with poor prognosis tumours
Time frame: Duration of study, 2-3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nandita deSouza, Professor principal investigator
ICR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To obtain histogram metrics(centiles, skew, kurtosis, entropy) for cervical cancer and compare them between histologically poor prognosis and good prognosis groups. (time frame: 1-2 months post imaging). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020; AzTrials last refreshed its copy on 1 Nov 2026.