Soft Tissue Detection on MRI, Cone Beam CT and Fan Beam CT and Integration of Functional MRI
NCT ID: NCT01859338
Last Updated: 2018-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
26 participants
OBSERVATIONAL
2012-03-06
2017-01-24
Brief Summary
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Detailed Description
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I. Establish the technical feasibility of MRI for performing functional soft-tissue targeting of radiotherapy in the pelvis and thorax. (Group I) II. Acquire clinical MR imaging data to evaluate image quality tradeoffs and operational parameter settings. (Group I) III. Validate the selection of MRI technique factors by comparing visibility of soft tissue structures in MRIs, cone beam (CB)CTs and fan beam (FB)CTs of the same patient. (Group II) IV. Assess the feasibility of using deformable image registration to map contours from FBCT to MRI, CBCT to MRI, MRI to MRI and vice versa. (Group II) V. Compare morphologic and functional changes in target and normal structures, visualized on MRI, CBCT and FBCT images, in response to radiation therapy and identify opportunities for treatment adaptation. (Group II)
OUTLINE:
Patients undergo MRI and FBCT at baseline, within the first 3 weeks of radiotherapy and between week 4 and 6 of radiotherapy. Patients with lung cancer may undergo 4 dimensional (4D) CBCT on the same day as the second and third MRI and FBCT.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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MRI, CBCT, FBCT
Patients undergo MRI and fan beam CT (FBCT) at baseline, within the first 3 weeks of radiotherapy and between week 4 and 6 of radiotherapy. Patients with lung cancer may undergo 4D cone beam x-ray CT (CBCT) on the same day as the second and third MRI and FBCT.
cone-beam computed tomography
Undergo CBCT
magnetic resonance imaging
Undergo MRI
computed tomography
Undergo fan beam computed tomography
Interventions
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cone-beam computed tomography
Undergo CBCT
magnetic resonance imaging
Undergo MRI
computed tomography
Undergo fan beam computed tomography
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* All patients must give written informed consent on a form that includes Health Insurance Portability and Accountability Act (HIPAA) authorization; patient therapy will not be directed by enrollment in this study; participation in this study will not preclude patient participation in additional therapy protocols; subjects will all be recruited from patients undergoing radiotherapy at one of the Virginia Commonwealth University (VCU)-affiliated radiotherapy clinics
Exclusion Criteria
* Patients with metal implants including pace makers and defibrillators
* Patients with cerebral aneurysm clips or middle ear implant
* Patients with pain pump, a programmable shunt, or non-surgical metal (i.e. a foreign body)
* Claustrophobic patients
* Prior radiotherapy to body area under investigation
* No vulnerable populations will be enrolled (prisoners, children, pregnant females, or institutionalized individuals); women of childbearing potential will undergo a pregnancy test
18 Years
ALL
No
Sponsors
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Virginia Commonwealth University
OTHER
Responsible Party
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Principal Investigators
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Elisabeth Weiss, MD
Role: PRINCIPAL_INVESTIGATOR
Massey Cancer Center
Locations
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Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States
Countries
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Other Identifiers
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NCI-2013-00847
Identifier Type: REGISTRY
Identifier Source: secondary_id
MCC-13777
Identifier Type: OTHER
Identifier Source: secondary_id
HM13777
Identifier Type: -
Identifier Source: org_study_id
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