Clinical Evaluation of Soft Tissue Detection on MRI, Cone Beam CT and Fan Beam CT and Integration of Functional MR Imaging Into Radiotherapy Planning
18 Years
N/A
Both
Lung Cancer, Prostate Cancer
Trial Information
Clinical Evaluation of Soft Tissue Detection on MRI, Cone Beam CT and Fan Beam CT and Integration of Functional MR Imaging Into Radiotherapy Planning
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Technical feasibility of MRI for performing functional soft-tissue targeting of radiotherapy in the pelvis and thorax
Outcome Description:
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.
Outcome Time Frame:
up to 6 weeks
Safety Issue:
No
Principal Investigator
Elisabeth Weiss
Investigator Role:
Principal Investigator
Investigator Affiliation:
Massey Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
HM13777
NCT ID:
NCT01859338
Start Date:
March 2012
Completion Date:
March 2016
Related Keywords:
- Lung Cancer
- Prostate Cancer
- Lung Neoplasms
- Prostatic Neoplasms
Name | Location |
|---|---|
| Virginia Commonwealth University/Massey Cancer Center | Richmond, Virginia 23298 |
