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

Lung Cancer Clinical Trial

Official title:

Investigating the Feasibility of Using Real-time Cine-MRI for Treating Moving and Deforming Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01071434
• Other study ID #: VAR0042
• Secondary ID: SU-06112009-2702
• Status: Terminated
• Phase: N/A
• First received: December 16, 2009
• Last updated: December 5, 2012
• Start date: February 2009
• Est. completion date: September 2010

Study information

• Verified date: December 2012
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Carcinoma, Non-Small-Cell Lung
• Hepatobiliary Cancers
• Hepatobiliary Cancers Bile Duct
• Hepatobiliary Cancers Gallbladder
• Hepatobiliary Cancers Hepatocellular Carcinoma (Hepatoma)
• Hepatobiliary Cancers Liver
• Liver Cancer
• Lung Cancer
• Lung Cancer Non-Small Cell Cancer (NSCLC)
• Lung Cancer Small Cell Lung Cancer (SCLC)
• Lung Neoplasms
• Pancreatic Cancer
• Pancreatic Neoplasms
• Small Cell Lung Carcinoma

Intervention

Procedure:
• MR Imaging

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	The American Association of Physicists in Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		two hours	No