Prediction of Clinical Response and Outcome in Uterine Cervix Cancer

March 29, 2016 updated by: Maastricht Radiation Oncology

Predicting Clinical Response and Outcome After Definitive Irradiation With MRI-Guided Adaptive Brachytherapy in Uterine Cervix Cancer

Observational study based on the routine clinical treatment and diagnostic course, to correlate imaging features with outcome objectives. Outcome will evaluated as clinical response to the standard treatment and as recurrence and survival in the follow up. The study hypothesis is that data extracted form FDG-PETCT used in the routine clinical practice can predict outcomes following standard treatment.

Study Overview

Status

Completed

Conditions

Detailed Description

This study will prospectively collect patients undergoing to the standard diagnostic and treatment protocol in Maastro Clinic. Any difference in the normal procedure will be adopted. The aim is to extrapolate form the PET images some features of the metabolic tumor activity to associate with different outcomes and tumor behaviours.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6202NA
        • Philippe Lambin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Histologically proven cervical uterine cancer, undergoing to conventional radiotherapy.

Description

Inclusion Criteria:

  • Histologically confirmed cervix carcinoma (all subtypes)
  • Tumor Stages FIGO IB - IVA
  • Scheduled for primary curative radiotherapy (either or not combined with chemotherapy or hyperthermia)
  • pre treatment FDG PETCT
  • The patient is willing and capable to comply with study procedures
  • 18 years or older
  • Written informed consent to the treatment

Exclusion Criteria:

  • Recent (< 3 months) myocardial infarction
  • Uncontrolled infectious disease
  • Pregnant or breast feeding and/or not willing to take adequate contraceptive measures during the study
  • Previous surgery to the Cervix
  • Previous radiation to the Cervix

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of SUV-related tumor characteristics predicting recurrence
Time Frame: Changes of parameters will be calculated on the pretreatment scan, than in average 2.5 months after the last radiotherapy session, than at least each 6 month for the first 2 years, eventually shortening the interval if clinically needed
  • Standard Uptake Value Max (SUV- defined as the ratio of tissue radioactivity concentration (e.g. in MBq/kg=kBq/g) at time t, c(t), and the injected activity ( in MBq) at the time of injection (t=0) divided by the body weight in kg),
  • Metabolic Volume (MV) calculated in cc:volume of the evaluable metabolic activity on the PET scan calculated in a specific Region of Interest (ROI) semiautomatically delineated on the primary tumor in the uterine Cervix
Changes of parameters will be calculated on the pretreatment scan, than in average 2.5 months after the last radiotherapy session, than at least each 6 month for the first 2 years, eventually shortening the interval if clinically needed

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of SUV-related tumor characteristics predicting clinical overall response
Time Frame: Changes of parameters will be calculated on the pretreatment scan, and in average 2.5 months after the last radiotherapy session.
  • Standard Uptake Value Max (SUV- defined as the ratio of tissue radioactivity concentration (e.g. in MBq/kg=kBq/g) at time t, c(t), and the injected activity ( in MBq) at the time of injection (t=0) divided by the body weight in kg),
  • Ratio of Pre/Post treatment SUV MAX,
Changes of parameters will be calculated on the pretreatment scan, and in average 2.5 months after the last radiotherapy session.
Radiomics Features
Time Frame: Radiomics features will be evaluated on the preteratment CT-fdg PET scan in average at least 2 weeks after the end of the accrual.
  • We will apply a high throughput approach to convert medical images to minable data, where it is hypothesized that it will improve tumor characterization and treatment outcome prediction.
  • Extracted imaging features consist firstly of global properties, providing information on the first order histogram of voxel intensity values within the tumor VOI.
  • Local and regional textural features describing patterns and spatial distribution of voxel intensities, are calculated from respectively gray level co-occurrence and gray level run-length matrix representations. Images will be discretized before texture analysis, which allows for a direct comparison of all calculated textural features between patients. Co-occurrence and gray level run-length matrices are determined considering 26-connected voxels (i.e. voxels were considered to be neighbors in all 13 directions in three dimensions) and a distance of 1 between consecutive voxels. Features derived from the co-occurrence and gray
Radiomics features will be evaluated on the preteratment CT-fdg PET scan in average at least 2 weeks after the end of the accrual.
Interobserver variability of Gross Tumor Volume (GTV) contours
Time Frame: GTV's will be delineated 2 weeks after the end of accrual
  • GTV volume in cc contoured by 5 different observers on pretreatment scan: the difference in cc between each contour obtained will be scored
  • GTV Overlapping fraction rate: the overlapping rate of GTV volume between contours
GTV's will be delineated 2 weeks after the end of accrual

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht Radiation Oncology

Collaborators

Maastricht University Medical Center

Investigators

  • Principal Investigator: philippe Lambin, Maastro Clinic, The Netherlands

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

November 12, 2012

First Submitted That Met QC Criteria

January 7, 2013

First Posted (Estimate)

January 9, 2013

Study Record Updates

Last Update Posted (Estimate)

March 30, 2016

Last Update Submitted That Met QC Criteria

March 29, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CERVMA01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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