Pilot Study of Regional Lung Ventilation
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|ClinicalTrials.gov Identifier: NCT03077113|
Recruitment Status : Completed
First Posted : March 10, 2017
Last Update Posted : March 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Diagnostic Test: 4-D CT Scan Diagnostic Test: SPECT-CT Scan||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Regional Lung Ventilation: Comparing Ventilation Images Computed From 4D CTs vs. Traditional Nuclear Medicine Ventilation Images|
|Actual Study Start Date :||October 15, 2012|
|Actual Primary Completion Date :||April 16, 2015|
|Actual Study Completion Date :||August 23, 2016|
Ventilation Images for Comparison
Standard of Care: 4-D CT scan will be used to make a radiation treatment plan.
SPECT-CT Scan: This second scan will be done on another day to make a treatment plan for comparison to the first plan.
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.
Other Name: 4-D computed tomography
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.
Other Name: Single-photon emission computed tomography
- Rate of Correlation of Ventilation Images [ Time Frame: Up to 1 year ]The primary objective is to compare the regional ventilation using SPECT-CT and that as determined from the pre-treatment 4D-CT routinely collected at simulation in lung/abdominal patients (standard of care). 50% of the lower portion lung image will be used for the purpose of determining the regional ventilation for this protocol.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077113
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Thomas Dilling, M.D.||H. Lee Moffitt Cancer Center and Research Institute|