Prediction of Clinical Response and Outcome in Uterine Cervix Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Maastricht Radiation Oncology
Sponsor:
Collaborator:
Maastricht University Medical Center
Information provided by (Responsible Party):
Maastricht Radiation Oncology
ClinicalTrials.gov Identifier:
NCT01764217
First received: November 12, 2012
Last updated: January 7, 2013
Last verified: January 2013
  Purpose

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.


Condition
Cervix Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predicting Clinical Response and Outcome After Definitive Irradiation With MRI-Guided Adaptive Brachytherapy in Uterine Cervix Cancer

Resource links provided by NLM:


Further study details as provided by Maastricht Radiation Oncology:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    • 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


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    • 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,

  • 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. ] [ Designated as safety issue: No ]
    • 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

  • Interobserver variability of Gross Tumor Volume (GTV) contours [ Time Frame: GTV's will be delineated 2 weeks after the end of accrual ] [ Designated as safety issue: No ]
    • 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


Estimated Enrollment: 100
Study Start Date: July 2006
Estimated Study Completion Date: January 2013
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Histologically proven cervical uterine cancer, undergoing to conventional radiotherapy.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01764217

Contacts
Contact: Philippe Lambin, Prof 0031884455666 philippe.lambin@maastro.nl
Contact: Ludy Lutgens 003188445566 ludy.lutgens@maastro.nl

Locations
Netherlands
Philippe Lambin Recruiting
Maastricht, Limburg, Netherlands, 6202NA
Contact: Philippe Lambin    0031884455666    philippe.lambin@maastro.nl   
Contact: ludy Lutgens    0031884455666    ludy.lutgens@maastro.nl   
Sub-Investigator: ludy lutgens         
Sponsors and Collaborators
Maastricht Radiation Oncology
Maastricht University Medical Center
Investigators
Principal Investigator: philippe Lambin Maastro Clinic, The Netherlands
  More Information

No publications provided

Responsible Party: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT01764217     History of Changes
Other Study ID Numbers: CERVMA01
Study First Received: November 12, 2012
Last Updated: January 7, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Maastricht Radiation Oncology:
Cervix Cancer
SUV
Radiotherapy
Outcome Prediction
Imaging
PET

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on October 19, 2014