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Soft Tissue Detection on MRI, Cone Beam CT and Fan Beam CT and Integration of Functional MRI

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ClinicalTrials.gov Identifier: NCT01859338
Recruitment Status : Terminated (Slow accrual)
First Posted : May 21, 2013
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
This clinical trial studies magnetic resonance imaging (MRI), cone beam computed tomography (CT), and fan beam CT in detecting soft tissue in patients with prostate and lung cancer undergoing radiation therapy. Comparing results of diagnostic procedures done before and during radiation therapy may help doctors predict a patient's response to treatment and help plan the best treatment.

Condition or disease Intervention/treatment
Lung Cancer Prostate Cancer Radiation: cone-beam computed tomography Radiation: magnetic resonance imaging Radiation: computed tomography

Detailed Description:

PRIMARY OBJECTIVES:

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.


Study Type : Observational
Actual Enrollment : 26 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Evaluation of Soft Tissue Detection on MRI, Cone Beam CT and Fan Beam CT and Integration of Functional MR Imaging Into Radiotherapy Planning
Study Start Date : March 6, 2012
Actual Primary Completion Date : January 18, 2017
Actual Study Completion Date : January 24, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Radiation: cone-beam computed tomography
Undergo CBCT
Other Name: CBCT

Radiation: magnetic resonance imaging
Undergo MRI
Other Names:
  • MRI
  • NMR imaging
  • NMRI
  • nuclear magnetic resonance imaging

Radiation: computed tomography
Undergo fan beam computed tomography
Other Name: tomography, computed




Primary Outcome Measures :
  1. Technical feasibility of MRI for performing functional soft-tissue targeting of radiotherapy in the pelvis and thorax [ Time Frame: up to 6 weeks ]
    Make a preliminary comparison of soft tissue structures delineated from MRI to those identified based on cone beam CT (CBCT) and fan beam CT (FBCT). In addition, variations in the soft tissue identification from repeated MR imaging will be compared to morphological imaging.

  2. Clinical MR imaging data in evaluating image quality tradeoffs and operational parameter settings [ Time Frame: Up to 6 weeks ]
    Image quality will be assessed by evaluating the utility of various comparative image quality quantifiers such as signal-to-noise ratio (SNR), resolution, and reproducibility of soft-tissue structure identification.


Secondary Outcome Measures :
  1. Visibility of soft tissue structures in MRIs, CBCTs and FBCTs of the same patient [ Time Frame: Up to 6 weeks ]
    Compared using a paired t-test.

  2. Deformable image registration to map contours from FBCT to MRI, CBCT to MRI, MRI to MRI and vice versa [ Time Frame: Up to 6 weeks ]
    Compared using a paired t-test.

  3. 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 [ Time Frame: Up to 6 weeks ]
    Compared using a paired t-test.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are treated in the Massey Cancer Center Radiation Therapy will be recruited for this observational study.
Criteria

Inclusion Criteria:

  • Patients with lung cancer visible on CT who are scheduled to receive radiation treatment to the area of the primary tumor will be eligible for this study - Renal function tests (blood urea nitrogen [BUN], creatinine [Cr], glomerular filtration rate [GFR]) within 30 days of MRI with GFR > 59 mL/min
  • 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 requiring continuous supplemental oxygen
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01859338


Locations
United States, Virginia
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Elisabeth Weiss, MD Massey Cancer Center

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01859338     History of Changes
Other Study ID Numbers: HM13777
NCI-2013-00847 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MCC-13777 ( Other Identifier: Massey Cancer Center )
First Posted: May 21, 2013    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No