Ignite Creation Date:
2024-05-06 @ 8:28 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02745548
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2016-04-08
Brief Title:
Bronchial Mapping GCC 1635
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Investigating Radiation-Induced Injury to Airways and Pulmonary Vasculature in Lung Stereotactic Ablative Body Radiotherapy SAbR
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In order to better understand radiation-induced lung toxicity the investigator proposes a novel functional avoidance approach that incorporates central as well as peripheral BSS segments in the treatment planning process in order to quantify and account for their respective radiosensitivities Specifically the investigator proposes a systematic study that involves acquiring pre- and post-SAbR high-resolution CT and SPECT VQ scans from lung cancer patients who receive radiotherapy followed by auto-segmentation of the BSS elements using virtual bronchoscopy
Detailed Description:
Very few recent lung cancer therapies have had as positive an impact on public health as lung SAbR Lung SAbR involves the precise administration of very high biologically potent doses 54-70 Gy in 3-5 fractions The most recent update of the Radiation Therapy Oncology Group RTOG 0236 Phase II multi-center lung SAbR trial showed 5-year primary tumor control 90 in inoperable Stage I NSCLC patients with tumors 5cm However the use of such highly potent doses puts patients at risk for collateral toxicity including radiation pneumonitis and radiation injury to airways causing stenosis atelectasis and ultimately fibrosis A review of 35 early-stage NSCLC SAbR clinical studies found that the reported maximum values of Grade 3 toxicities were between 10-28 In the RTOG 0236 trial 17 patients presented Grade 3 toxicities Furthermore toxicity has been shown to increase dramatically for centrally-located andor larger 5cm early-stage tumors Due to these concerns in current clinical practice the use of high-dose-per-fraction lung SAbR is routinely indicated only for a small percentage 3 - 4 of the NSCLC population - inoperable early-stage patients with small peripheral lesions Inoperable patients with early-stage central andor larger tumors higher stage andor multiple lesions and pulmonary oligometastases metastatic disease that is limited in number of lesions and sites are either treated with conventional radiotherapy andor chemotherapy 30 - 40 5-year survival or not treated median survival 1 year
The segmented structures will be imported into a clinical radiotherapy treatment planning system in order to calculate dose to individual BSS elements Follow-up CT images and follow-up SPECT VQ scans will be used to characterize the radiosensitivity of these structures and spatially map the potential radiation-induced loss of lung function Eventually using this information the investigator will investigate treatment planning strategies that help limit radiation dose and consequent damage to BSS elements thereby reducing lung toxicity The investigator hypothesizes that - Anatomically variable radiation injury to the bronchial tree and pulmonary vasculature is an important determinant of post-SAbR pulmonary toxicity and residual pulmonary function
The segmented structures will be imported into a clinical radiotherapy treatment planning system in order to calculate dose to individual BSS elements Follow-up CT images and follow-up SPECT VQ scans will be used to characterize the radiosensitivity of these structures and spatially map the potential radiation-induced loss of lung function Eventually using this information the investigator will investigate treatment planning strategies that help limit radiation dose and consequent damage to BSS elements thereby reducing lung toxicity The investigator hypothesizes that - Anatomically variable radiation injury to the bronchial tree and pulmonary vasculature is an important determinant of post-SAbR pulmonary toxicity and residual pulmonary function
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None