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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01859338
• Other study ID #: HM13777
• Secondary ID: NCI-2013-00847MC
• Status: Terminated
• Phase: N/A
• First received: May 7, 2013
• Last updated: March 6, 2018
• Start date: March 6, 2012
• Est. completion date: January 24, 2017

Study information

• Verified date: March 2018
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 26
• Est. completion date: January 24, 2017
• Est. primary completion date: January 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Prostate Cancer

Intervention

Radiation:
• cone-beam computed tomography
Undergo CBCT
• magnetic resonance imaging
Undergo MRI
• computed tomography
Undergo fan beam computed tomography

Locations

Country	Name	City	State
United States	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical feasibility of MRI for performing functional soft-tissue targeting of radiotherapy in the pelvis and thorax	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.	up to 6 weeks
Primary	Clinical MR imaging data in evaluating image quality tradeoffs and operational parameter settings	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.	Up to 6 weeks
Secondary	Visibility of soft tissue structures in MRIs, CBCTs and FBCTs of the same patient	Compared using a paired t-test.	Up to 6 weeks
Secondary	Deformable image registration to map contours from FBCT to MRI, CBCT to MRI, MRI to MRI and vice versa	Compared using a paired t-test.	Up to 6 weeks
Secondary	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	Compared using a paired t-test.	Up to 6 weeks