Clinical trial NCT01859338: Soft Tissue Detection on MRI, Cone Beam CT and Fan Beam CT and Integration of Functional MRI
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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Lung Cancer
Prostate Cancer
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2013-05-21
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Technical feasibility of MRI for performing functional soft-tissue targeting of radiotherapy in the pelvis and thorax
timeFrame: up to 6 weeks
measure: Clinical MR imaging data in evaluating image quality tradeoffs and operational parameter settings
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Visibility of soft tissue structures in MRIs, CBCTs and FBCTs of the same patient
timeFrame: Up to 6 weeks
measure: Deformable image registration to map contours from FBCT to MRI, CBCT to MRI, MRI to MRI and vice versa
timeFrame: Up to 6 weeks
measure: 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
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University/Massey Cancer Center
state: Virginia
Study officials:
affiliation: Massey Cancer Center
name: Elisabeth Weiss, MD
role: PRINCIPAL_INVESTIGATOR
References: