Diffusion-weighted MRI for Individualized Radiation Therapy Planning of Lung Cancer

NCT02059889 | Withdrawn DMC

• 4 other identifiers: MCC-13-09531HM20000190MCC20000190NCI-2014-00113
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial studies diffusion-weighted magnetic resonance imaging (MRI) in identifying and localizing tumors in patients with non-small cell lung cancer undergoing radiation therapy. Diagnostic procedures such as diffusion weighted MRI may help identify where active cancer is to improve the targeting accuracy of radiotherapy. Comparing results of diagnostic procedures done before, during, and after radiation therapy may help determine how the location and volume of tumors changes over time and predict how the tumor will respond to therapy.

Conditions

Recurrent Non-small Cell Lung Cancer; Stage IIA Non-small Cell Lung Cancer; Stage IIB Non-small Cell Lung Cancer; Stage IIIA Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer

Keywords

Lung

Outcome Measures

Primary Outcomes (4)

• Measurement of gross tumor volume and involved lymph nodes

  A paired sample t-test could be applied to test the difference between MRI, CT, and PET-CT contours. Parameters used for comparison will include volume size, volume overlap, such as Dice similarity coefficients and Jaccard index, and surface distance maps including Hausdorff distance.

  Up to 3 months

• Change in functional response

  Patients will be classified into responders and non-responders based on their PET signal which will serve as the reference method for response assessment. Although this is a little different from the three group analysis of variance (ANOVA) used in the power calculation, it is expected that there will be similar high power when the partial responders and non-responders are combined. Receiver operating characteristic (ROC) analysis will be used to define a threshold of apparent diffusion coefficient (ADC) change to stratify between metabolic responders vs. non-responders.

  Baseline to 3 months

• Spatial concordance of multimodality imaging for whole image registration

  A paired sample t-test will be used.

  Up to 3 months

• Temporospatial registrations of radioresistant sub-volumes

  A paired sample t-test will be used. ROC analysis will be performed only for radioresistant sub-volumes to identify which diffusion weighted-MRI functional signal thresholds correlate with levels of tumor activity defined on PET.

  Up to 3 months

Secondary Outcomes (1)

• Change in ADC

  Baseline to 4 weeks

Study Arms (1)

Diagnostic (diffusion-weighted MRI, 4D CT, FDG-PET)

EXPERIMENTAL

Patients undergo 15 imaging studies: 5 chest CT scans, 5 chest MRI scans, 5 PET scans. Each scan will be obtained before treatment begins, weeks 2 and 4 during radiation therapy, 3 months and 1 year following radiation therapy. THe chest CT obtained pre-treatment, at 3 months post treatment and 1 year post treatment are considered routine and would be obtained regardless of study participation. The pre-treatment PET scan is also considered routine. All other scans are being done for the purposes of this research.

Device: diffusion-weighted magnetic resonance imaging; Device: 4-dimensional computed tomography; Radiation: fludeoxyglucose F 18; Device: FDG-PET

Interventions

diffusion-weighted magnetic resonance imaging DEVICE

Undergo diffusion-weighted MRI

Also known as: diffusion-weighted MRI

Diagnostic (diffusion-weighted MRI, 4D CT, FDG-PET)

4-dimensional computed tomography DEVICE

Undergo 4D CT

Also known as: 4D-CT

Diagnostic (diffusion-weighted MRI, 4D CT, FDG-PET)

fludeoxyglucose F 18 RADIATION

Undergo FDG-PET

Also known as: 18FDG, 2-F18-fluoro-2-deoxyglucose, 63503-12-8, FDG, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, fluorodeoxyglucose F 18, Fluorodeoxyglucose F18

Diagnostic (diffusion-weighted MRI, 4D CT, FDG-PET)

FDG-PET DEVICE

Undergo FDG-PET

Also known as: FDG-PET, PET, PET scan, tomography, emission computed

Diagnostic (diffusion-weighted MRI, 4D CT, FDG-PET)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be able to undergo MRI imaging; contrast application will be determined according to institutional guidelines; patients with lung cancer or locally recurrent lung cancer (following surgery) who are scheduled to receive external beam radiation therapy for at least 6 weeks
• Tumor visible on planning CT scan
• Negative pregnancy test for women of childbearing potential prior to study entry

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)

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Diffusion Magnetic Resonance Imaging; Four-Dimensional Computed Tomography; Fluorodeoxyglucose F18; Positron-Emission Tomography; Tomography

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Image Interpretation, Computer-Assisted; Imaging, Three-Dimensional; Radiographic Image Enhancement; Radiography; Tomography, X-Ray; Deoxyglucose; Deoxy Sugars; Carbohydrates; Tomography, Emission-Computed; Image Enhancement; Photography; Radionuclide Imaging; Diagnostic Techniques, Radioisotope

Study Officials

• Elisabeth Weiss, MD

  Massey Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2014
• First Posted: February 11, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 16, 2016

Record last verified: 2016-12

Locations

US (1)