Intra-Pelvic Organ Motion for Cervix Cancer Patient Using Imaging - Full Text View

Sponsor:	University Health Network, Toronto
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00957450

Purpose

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
Cervix Cancer

Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cervical Cancer MRI Scans

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	20
Study Start Date:	February 2008
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00957450

Locations

Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2M9

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Principal Investigator:

Michael Milosevic, MD

Univesity Health Network, Princess Margaret Hospital

More Information

No publications provided

Responsible Party:	Dr. Michael Milosevic, Staff Radiation Oncologist, Clinician Scientist, University Health Network - Princess Margaret Hospital
ClinicalTrials.gov Identifier:	NCT00957450 History of Changes
Other Study ID Numbers:	UHN REB 08-0043-CE
Study First Received:	August 11, 2009
Last Updated:	August 10, 2010
Health Authority:	Canada: Ethics Review Committee

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

Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on February 09, 2012