Clinical Trials Directory

Trials / Completed

CompletedNCT03077113

Pilot Study of Regional Lung Ventilation

Pilot Study of Regional Lung Ventilation: Comparing Ventilation Images Computed From 4D CTs vs. Traditional Nuclear Medicine Ventilation Images

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
3 (actual)
Sponsor
H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is a prospective study of ventilation image comparison for lung functional information incorporation in thoracic cancer treatment planning.

Detailed description

Investigators hypothesize that a high resolution regional ventilation image (HRVI) based on 4D-CT imaging will correlate with the current low resolution state-of-the-art (SPECT-CT), which is the conventional way of measuring ventilation. HRVI may be a tool that could be widely used throughout the radiation therapy community because most radiation oncologists routinely employ 4D-CT technology in their own clinics. Investigators plan to test this hypothesis by comparing ventilation patterns on SPECT-CT images to HRVIs using a DICE analysis. As SPECT ventilation imaging is not included in our standard care, this study thus is designed as a pilot study. Based on published data, the difference between the two methods for calculating the regional ventilation in the lower 50% ventilation volume is expected to have a standard deviation of about 0.1. Therefore, the 95% confidence interval for the difference in the regional ventilation between SPECT-CT and 4D-CT pre-treatment would have a width of no more than 0.14 if 10 patients are enrolled and as small as 0.10 when 20 patients are registered.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TEST4-D CT ScanThe 4-D CT scan shows how the tumor moves when patients breathe so that motion can be taken into account when planning the radiation. This is the usual way of planning lung radiation and everyone in this study will be planned using a 4-D CT scan.
DIAGNOSTIC_TESTSPECT-CT ScanIt may be possible to make a more accurate plan by using a SPECT-CT scan for planning that would result in less damage to healthy lung tissue. This is not yet proven. A SPECT-CT scan uses a special camera to detect radioactivity to produce pictures which can lead to more precise information.

Timeline

Start date
2012-10-15
Primary completion
2015-04-16
Completion
2016-08-23
First posted
2017-03-10
Last updated
2017-03-13

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03077113. Inclusion in this directory is not an endorsement.