Clinical trial NCT01071434: Feasibility of Using Real-time Cine-MRI for Treating Moving & Deforming Tumors
Official title: Investigating the Feasibility of Using Real-time Cine-MRI for Treating Moving and Deforming Tumors
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: 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
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: The American Association of Physicists in Medicine
First posted: 2010-02-19
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible disease(s)/stage(s) \&#61485;\&#61472;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.

Brief 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.

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 criteria: Inclusion Criteria:3.1.1. Eligible disease(s)/stage(s) \&#61485;\&#61472;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 \&#61485; Any types and amounts of prior therapy will be allowed for this study.

3.1.3. Age restriction and/or gender/ethnic restrictions \&#61485;\&#61472;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 \&#61485; None.

3.1.5. ECOG or Karnofsky Performance Status \&#61485; Karnofsky performance status of 50 or greater

3.1.6. Requirements for organ and marrow function \&#61485; 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

Primary outcomes:
measure: 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.
timeFrame: two hours
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Amit Sawant
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Paul J Keall
role: PRINCIPAL_INVESTIGATOR
References: