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

Terminated

• Conditions: Prostate Cancer; Lung Cancer
• Interventions: Radiation: cone-beam computed tomography; Radiation: magnetic resonance imaging; Radiation: computed tomography

• Registration Number: NCT01859338
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-03-06
• Study First Submitted: 2013-05-07
• Study First Submitted QC: 2013-05-17
• Study First Posted: 2013-05-21
• Primary Completion: 2017-01-18
• Study Completion: 2017-01-24
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-06
• Last Update Posted: 2018-03-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MRI, CBCT, FBCT	computed tomography	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.
MRI, CBCT, FBCT	cone-beam computed tomography	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.
MRI, CBCT, FBCT	magnetic resonance imaging	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.

Primary Outcome Measures

Name	Time	Method
Clinical MR imaging data in evaluating image quality tradeoffs and operational parameter settings	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.
Technical feasibility of MRI for performing functional soft-tissue targeting of radiotherapy in the pelvis and thorax	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.

Secondary Outcome Measures

Name	Time	Method
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	Up to 6 weeks	Compared using a paired t-test.
Visibility of soft tissue structures in MRIs, CBCTs and FBCTs of the same patient	Up to 6 weeks	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	Up to 6 weeks	Compared using a paired t-test.

Trial Locations

Locations (1)

Virginia Commonwealth University/Massey Cancer Center; 🇺🇸 Richmond, Virginia, United States