Ignite Creation Date:
2024-05-06 @ 1:34 AM
Last Modification Date:
2024-10-26 @ 11:06 AM
Study NCT ID:
NCT01843673
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2013-04-26
Brief Title:
Image-Guided Adaptive Radiotherapy for in Detecting Tumors During Treatment in Patients With Head and Neck Cancer
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Image-Guided Adaptive Radiotherapy for Head And Neck Cancer Patient Image Acquisition
Status:
COMPLETED
Status Verified Date:
2016-05
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:
This clinical trial studies image-guided adaptive radiotherapy in detecting tumors during treatment in patients with head and neck cancer Image-guided adaptive radiotherapy uses high quality imaging technology to detect the tumor and normal organs during treatment It is not yet known which imaging technique provides the best image for guidance during treatment with radiation therapy Comparing results of imaging procedures done before during and after radiotherapy may help doctors plan the best treatment
Detailed Description:
I To conduct a clinical imaging study utilizing three novel in-room imaging systems Oblique Brainlab ExacTrac images Orthogonal Varian kilovoltage kV On-board Imaging OBI image and Varian cone-beam computed tomography CBCT imaging to assess their performance in reducing inter- and intrafractional setup errors relative to weekly megavoltage MV electronic portal imaging device EPID images using both bony landmarks and soft tissue changes for head and neck cancer HNC patients undergoing external beam radiation therapy RT
II To assess the accuracy of CBCT imaging for measuring systematic soft tissue changes in the head and neck HN area relative to conventional high resolution contrast enhanced fan-beam computed tomography CT FBCT as a standard
III To assess the systematic and random soft tissue motion errors using daily CBCT imaging relative to bony-landmark alignment to evaluate the benefit of soft tissue imaging during radiotherapy
IV To quantify soft tissue changes during an entire course of radiotherapy eg tumor shrinkage using daily CBCT imaging
V To determine the feasibility of using measured set up and soft-tissue motion uncertainties in conjunction with volume changes observed on serial CBCT images for offline adaptive replanning of HNC patients using available planning tools
VI To quantify the benefits of adaptive image-guided radiotherapy IGRT in HN patients in terms of target coverage and normal tissue avoidance
VII To determine the feasibility of mounting a phase III trial to assess the clinical benefits of image-guided adaptive radiotherapy IGART in terms of acute and late toxicities and tumor control
VIII To build a HNC patient database for future validation of IGART processes using deformable image registration and Virtual Clinical Trials VCTs
OUTLINE
Patients undergo FBCT once before treatment and once weekly for a total of 6-7 scans dual CBCT up to 5 times weekly for a total of 33-35 scans 2-dimensional 2-D x-ray with Varian kV OBI 5 times weekly for a total of 33-35 scans 2-D x-ray with Brain Lab ExacTrac 5 times weekly for a total of 33-35 scans 2-D x-ray with Varian MV OBI once weekly for a total of 6-7 scans and EPID imaging up to 5 times weekly for a total of 33-35 scans while undergoing IGART
II To assess the accuracy of CBCT imaging for measuring systematic soft tissue changes in the head and neck HN area relative to conventional high resolution contrast enhanced fan-beam computed tomography CT FBCT as a standard
III To assess the systematic and random soft tissue motion errors using daily CBCT imaging relative to bony-landmark alignment to evaluate the benefit of soft tissue imaging during radiotherapy
IV To quantify soft tissue changes during an entire course of radiotherapy eg tumor shrinkage using daily CBCT imaging
V To determine the feasibility of using measured set up and soft-tissue motion uncertainties in conjunction with volume changes observed on serial CBCT images for offline adaptive replanning of HNC patients using available planning tools
VI To quantify the benefits of adaptive image-guided radiotherapy IGRT in HN patients in terms of target coverage and normal tissue avoidance
VII To determine the feasibility of mounting a phase III trial to assess the clinical benefits of image-guided adaptive radiotherapy IGART in terms of acute and late toxicities and tumor control
VIII To build a HNC patient database for future validation of IGART processes using deformable image registration and Virtual Clinical Trials VCTs
OUTLINE
Patients undergo FBCT once before treatment and once weekly for a total of 6-7 scans dual CBCT up to 5 times weekly for a total of 33-35 scans 2-dimensional 2-D x-ray with Varian kV OBI 5 times weekly for a total of 33-35 scans 2-D x-ray with Brain Lab ExacTrac 5 times weekly for a total of 33-35 scans 2-D x-ray with Varian MV OBI once weekly for a total of 6-7 scans and EPID imaging up to 5 times weekly for a total of 33-35 scans while undergoing IGART
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2013-00846 | REGISTRY | None | None |
| HM11639 | OTHER | Virginia Commonwealth University IRB | None |