Intra-Pelvic Organ Motion for Cervix Cancer Patient Using Imaging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00957450
Recruitment Status : Active, not recruiting
First Posted : August 12, 2009
Last Update Posted : February 21, 2018
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
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.

Condition or disease
Cervix Cancer

Detailed Description:
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.

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation Study of Modeled Intra-pelvic Organ Motion During External Beam Radiotherapy for Cervix Cancer Using Frequent Magnetic Resonance Imaging
Study Start Date : February 2008
Actual Primary Completion Date : February 2017
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources


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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
In this study, the organ motion of Patients with cervical cancer will be assessed. The study population will be selected from clinic.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00957450

Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Principal Investigator: Michael Milosevic, MD Univesity Health Network, Princess Margaret Hospital

Responsible Party: University Health Network, Toronto Identifier: NCT00957450     History of Changes
Other Study ID Numbers: UHN REB 08-0043-CE
First Posted: August 12, 2009    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018

Keywords provided by University Health Network, Toronto:
cervix cancer
intra-pelvic organ motion
cervical cancer and CBCT

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