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
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | 4-D CT Scan | The 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_TEST | SPECT-CT Scan | It 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.