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Intra-Pelvic Organ Motion for Cervix Cancer Patient Using Imaging

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00957450
First received: August 11, 2009
Last updated: June 24, 2014
Last verified: June 2014

August 11, 2009
June 24, 2014
February 2008
February 2015   (final data collection date for primary outcome measure)
Measure inter-fraction organ movements associated with cervix cancer during the course of definitive radiotherapy. Characterise the impact of bladder and rectal filling on target motion during a course of definitive radiotherapy [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00957450 on ClinicalTrials.gov Archive Site
Model intra-pelvic organ motion during RT. Model tumour & normal tissue dose accumulation. Perform planning studies on the image data sets. Investigate the utility of tumour localisation surrogates using CBCT & MR imaging. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Intra-Pelvic Organ Motion for Cervix Cancer Patient Using Imaging
Validation Study of Modeled Intra-pelvic Organ Motion During External Beam Radiotherapy for Cervix Cancer Using Frequent Magnetic Resonance Imaging

Patients with cervix cancer having radiotherapy experience side-effects because the radiotherapy fields have to be quite large to account for tumour movement in the pelvis during treatment, this irradiates a lot of normal tissues. This study aims to characterize and model the tumour motion, as well as the motion of surrounding normal tissues, during treatment. By doing this, the investigators can look at ways to minimise tumour motion and spare more normal tissues. By tailoring the radiotherapy dose more accurately, the investigators will reduce the side-effects of treatment and improve local control of the tumour. By doing multiple magnetic resonance imaging (MRI) scans of the patients during treatment, the investigators can identify where the tumour and surrounding normal tissues are at that point in time. Collecting all the information from these scans, will allow the investigators to model the motion of the tumour and these pelvic organs, and investigate the best way to target the tumour while still sparing normal tissues.

At simulation: patients will have two MRI scans in addition to the standard planning CT scan. One MRI scan will be with bladder full, the other will be with bladder empty. During treatment: patients will have two or three MRI scans per week at their convenience. MRI scans will be scheduled close to radiotherapy treatment times to minimise inconvenience for the patient. On the same day they have an MRI scan, they will also have a CBCT at the time of treatment. None of the images will be used to alter or influence the treatment the patient is receiving. If the patient feels that the imaging schedule is too inconvenient, they will be given the option to reduce the frequency of the scanning or to withdraw from the study.All the images will be loaded onto a password secure server. The MRI scans will be fused to the planning CT scan using bone-to-bone matching. Tumour and intra-pelvic organs will be contoured on the MRI scans. The contours will be used to create surface meshes of each organ and with research software, we will be able to model the motion and deformation of these organs over the course of radiotherapy. Using this data, we will be able to simulate the dose impact of the organ motion on different intensity-modulated radiotherapy plans. We will also explore the impact of bladder & rectal filling on tumour motion.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

In this study, the organ motion of Patients with cervical cancer will be assessed. The study population will be selected from clinic.

Cervix Cancer
Not Provided
1

Impact of organ motion

Characterize the impact of normal organ motion in the pelvic on tumour movement, during treatment. This will be assessed in patients with pelvic cancer.

Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
February 2015
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age ≥ 18years
  • Biopsy confirmed cervix cancer
  • Not suitable for surgery
  • Suitable for radical radiotherapy
  • ECOG 0-2
  • Informed consent

Exclusion Criteria:

  • Patients unwilling or unable to give informed consent
  • Prior pelvic radiotherapy
  • Contraindications to MRI scan
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00957450
UHN REB 08-0043-CE
Yes
University Health Network, Toronto
University Health Network, Toronto
Not Provided
Principal Investigator: Michael Milosevic, MD Univesity Health Network, Princess Margaret Hospital
University Health Network, Toronto
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP