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

Stage IIIB Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02059889
• Other study ID #: MCC-13-09531
• Secondary ID: HM20000190MCC200
• Status: Withdrawn
• Phase: N/A
• First received: February 7, 2014
• Last updated: December 15, 2016
• Start date: July 2014
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

PRIMARY OBJECTIVES:

I. Assess diffusion-weighted MRI as an early predictor for tumor response in patients with non-small cell lung cancer (NSCLC).

II. Establish the potential of individualized radiotherapy targeting of radioresistant tumor sub-volumes.

OUTLINE:

Patients undergo diffusion-weighted MRI within 4 weeks of radiation start (baseline), during the second week of radiation therapy, during the fourth week of radiation therapy, and at 3 months after radiation therapy (post-treatment). Patients also undergo standard of care 4-dimensional (4D) computed tomography (CT) and fludeoxyglucose F 18 (FDG)-positron emission tomography (PET) at the same time points.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 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

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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• 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

Intervention

Device:
• diffusion-weighted magnetic resonance imaging
Undergo diffusion-weighted MRI
• 4-dimensional computed tomography
Undergo 4D CT

Radiation:
• fludeoxyglucose F 18
Undergo FDG-PET

Device:
• FDG-PET
Undergo FDG-PET

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	Spatial concordance of multimodality imaging for whole image registration	A paired sample t-test will be used.	Up to 3 months	No
Primary	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	No
Secondary	Change in ADC	Fourth week ADC change will be compared to metabolic response defined by the fourth week PET using three group ANOVA and ROC analysis.	Baseline to 4 weeks	No