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Feasibility of Using Real-time Cine-MRI for Treating Moving & Deforming Tumors

This study has been terminated.
(PI left)
Sponsor:
Collaborator:
The American Association of Physicists in Medicine
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01071434
First received: December 16, 2009
Last updated: December 5, 2012
Last verified: December 2012
  Purpose
This study aims to investigate and optimize imaging sequences and parameters of rapid real-time MRI in order to obtain adequate guidance for accurately and precisely delivering radiation to moving abdominal and thoracic tumors.

Condition Intervention
Pancreatic Cancer Liver Cancer Lung Cancer Lung Cancer Non-Small Cell Cancer (NSCLC) Lung Cancer Small Cell Lung Cancer (SCLC) Hepatobiliary Cancers Hepatobiliary Cancers Liver Hepatobiliary Cancers Hepatocellular Carcinoma (Hepatoma) Hepatobiliary Cancers Gallbladder Hepatobiliary Cancers Bile Duct Procedure: MR Imaging

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Investigating the Feasibility of Using Real-time Cine-MRI for Treating Moving and Deforming Tumors

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • investigate and optimize imaging sequences and parameters of rapid real-time MRI in order to obtain adequate guidance for accurately and precisely delivering radiation to moving abdominal and thoracic tumors. [ Time Frame: two hours ]

Enrollment: 5
Study Start Date: February 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Detailed Description:

Accurate dose delivery remains one of the weakest aspects of radiotherapy, especially in the case of thoracic and abdominal tumors, where significant patient motion occurs during dose delivery (intrafraction motion). Such motion results in geometric and dosimetric uncertainties that compromise treatment quality. Effective management of intrafraction motion is therefore key to realizing the full potential of modern image-guided radiation therapy (IGRT). While external markers have been found to be well-correlated with internal anatomy within an imaging session, there is no guarantee that these correlations will continue to exist and be constant throughout the course of the therapy. In general, implanted, radio-opaque seeds have been found to be more reliable than external markers. However, implantation of fiducials, whether radio-opaque or electromagnetic, is necessarily invasive and carries with it the risk of associated complications - an issue that becomes especially important for cancer patients with weakened immune systems. Currently, MR imaging is the only modality that is non-invasive and provides high quality volumetric information for the whole body.

The "ideal" intrafraction motion management requires complete spatio-temporal knowledge of the irradiated anatomy. However, to date, there is no clinical method of directly visualizing the tumor volume during dose delivery. Most techniques rely on external or internal surrogate markers which often provide (usually non-volumetric) information of limited accuracy and reliability. In addition, internal markers impose significant "costs" on the patient in terms of interventional complications and increased imaging dose. In this work, we investigate the feasibility of using in-room, fast cine MR imaging as a non-invasive means to provide real-time, soft-tissue-based, volumetric image guidance for continuous monitoring of the target and surrounding anatomy. To date, there has been no systematic investigation of the imaging requirements of an integrated MRI+linac for the specific task of real-time radiotherapy guidance.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Eligible disease(s)/stage(s) AJCC Stage I, II, III or IV lung, liver or pancreatic cancer of any histology to be treated using radiotherapy will be eligible for this study.
Criteria

Inclusion Criteria:3.1.1. Eligible disease(s)/stage(s) AJCC Stage I, II, III or IV lung, liver or pancreatic cancer of any histology to be treated using radiotherapy will be eligible for this study.

3.1.2. Allowable type and amount of prior therapy  Any types and amounts of prior therapy will be allowed for this study.

3.1.3. Age restriction and/or gender/ethnic restrictions Patients must be greater than or equal to 18 years of age. There are no gender or ethnic restrictions.

3.1.4. Life expectancy restrictions  None.

3.1.5. ECOG or Karnofsky Performance Status  Karnofsky performance status of 50 or greater

3.1.6. Requirements for organ and marrow function  None.

3.1.7. Ability to understand and the willingness to sign a written informed consent document.

3.1.8. Pain-free in supine position

Exclusion Criteria:3.2.1 Children (age <18)

3.2.2 Metallic implants, embedded metallic objects, implanted biomedical devices e.g., cardiac pacemakers

3.2.3 Women who are pregnant or trying to get pregnant

3.2.4 Pain in supine position

3.2.5 Karnofsky performance status < 50

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01071434

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
The American Association of Physicists in Medicine
Investigators
Principal Investigator: Amit Sawant Stanford University
Principal Investigator: Paul J Keall Stanford University
  More Information

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01071434     History of Changes
Other Study ID Numbers: VAR0042
SU-06112009-2702 ( Other Identifier: Stanford University )
Study First Received: December 16, 2009
Last Updated: December 5, 2012

Additional relevant MeSH terms:
Lung Neoplasms
Pancreatic Neoplasms
Carcinoma, Hepatocellular
Small Cell Lung Carcinoma
Liver Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on August 17, 2017