MRI, Cone Beam CT, and Fan Beam CT in Detecting Soft Tissue in Patients With Prostate and Lung Cancer Undergoing Radiation Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Virginia Commonwealth University
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01859338
First received: May 7, 2013
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

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 Intervention
Lung Cancer
Prostate Cancer
Procedure: cone-beam computed tomography
Procedure: magnetic resonance imaging
Procedure: computed tomography

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Technical feasibility of MRI for performing functional soft-tissue targeting of radiotherapy in the pelvis and thorax [ Time Frame: up to 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Clinical MR imaging data in evaluating image quality tradeoffs and operational parameter settings [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
    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:
  • Visibility of soft tissue structures in MRIs, CBCTs and FBCTs of the same patient [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
    Compared using a paired t-test.

  • 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 ] [ Designated as safety issue: No ]
    Compared using a paired t-test.

  • 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 ] [ Designated as safety issue: No ]
    Compared using a paired t-test.


Estimated Enrollment: 20
Study Start Date: March 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supportive care (MRI, CBCT, FBCT)
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 4D CBCT on the same day as the second and third MRI and FBCT.
Procedure: cone-beam computed tomography
Undergo CBCT
Procedure: magnetic resonance imaging
Undergo MRI
Other Names:
  • MRI
  • NMR imaging
  • NMRI
  • nuclear magnetic resonance imaging
Procedure: computed tomography
Undergo fan beam computed tomography
Other Name: tomography, computed

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  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: NCT01859338

Locations
United States, Virginia
Virginia Commonwealth University/Massey Cancer Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Elisabeth Weiss    804-828-9463    eweiss@mcvh-vcu.edu   
Principal Investigator: Elisabeth Weiss         
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Elisabeth Weiss Massey Cancer Center
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01859338     History of Changes
Other Study ID Numbers: HM13777, NCI-2013-00847, MCC-13777
Study First Received: May 7, 2013
Last Updated: May 14, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Thoracic Neoplasms
Lung Neoplasms
Prostatic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 31, 2014