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


N/A
18 Years
N/A
Open (Enrolling)
Female
Cervix Cancer

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Change of SUV-related tumor characteristics predicting recurrence

Outcome Description:

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

Outcome 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

Safety Issue:

No

Principal Investigator

philippe Lambin

Investigator Role:

Principal Investigator

Investigator Affiliation:

MAASTRO Clinic

Authority:

Netherlands: Medical Ethics Review Committee (METC)

Study ID:

CERVMA01

NCT ID:

NCT01764217

Start Date:

July 2006

Completion Date:

January 2013

Related Keywords:

  • Cervix Cancer
  • Cervix Cancer
  • SUV
  • Radiotherapy
  • Outcome Prediction
  • Imaging
  • PET
  • Uterine Cervical Neoplasms

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