Prediction of Clinical Response and Outcome in Uterine Cervix Cancer

Cervix Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01764217
• Other study ID #: CERVMA01
• Status: Completed
• Phase: N/A
• First received: November 12, 2012
• Last updated: March 29, 2016
• Start date: July 2006
• Est. completion date: January 2013

Study information

• Verified date: March 2016
• Source: Maastricht Radiation Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2013
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cervix Cancer
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
Netherlands	Philippe Lambin	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht Radiation Oncology	Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of SUV-related tumor characteristics predicting recurrence	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	No
Secondary	Change of SUV-related tumor characteristics predicting clinical overall response	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.	No
Secondary	Radiomics Features	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.	No
Secondary	Interobserver variability of Gross Tumor Volume (GTV) contours	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	No