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

NCT01859338 | Terminated DMC

• 3 other identifiers: HM13777NCI-2013-00847MCC-13777
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Visibility of soft tissue structures in MRIs, CBCTs and FBCTs of the same patient

  Up to 6 weeks

• Deformable image registration to map contours from FBCT to MRI, CBCT to MRI, MRI to MRI and vice versa

  Up to 6 weeks

• 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

Study Arms (1)

MRI, CBCT, FBCT

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.

Radiation: cone-beam computed tomography; Radiation: magnetic resonance imaging; Radiation: computed tomography

Interventions

cone-beam computed tomography RADIATION

Undergo CBCT

Also known as: CBCT

MRI, CBCT, FBCT

magnetic resonance imaging RADIATION

Undergo MRI

Also known as: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging

MRI, CBCT, FBCT

computed tomography RADIATION

Undergo fan beam computed tomography

Also known as: tomography, computed

MRI, CBCT, FBCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Prostatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Elisabeth Weiss, MD

  Massey Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2013
• First Posted: May 21, 2013
• Study Start: March 6, 2012
• Primary Completion: January 18, 2017
• Study Completion: January 24, 2017
• Last Updated: March 7, 2018

Record last verified: 2018-03

Locations

US (1)