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MRI Adaptive Replanning Using ViewRay

NCT02950792 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-08-25

No results posted yet for this study

Summary

Current dose escalation regimens with and without chemotherapy have failed to achieve improved local control and overall survival over standard of care therapy to date. Difficulties with dose escalation have been largely due to dose limiting toxicities of surrounding normal organs, in particular to the normal lung parenchyma, and esophagus. Real time, online adaptive planning using magnetic resonance imaging (MRI) could achieve significant volume reduction of primary lung disease over the course of therapy, thereby reducing dose to normal structures, and providing a mechanism in which to dose escalate safely, and more effectively with accurate target delineation.

The investigators hypothesize that MRI based adaptive planning will provide a novel method to dose escalate safely with acceptable organ at risk doses. In addition, further improvements in radiotherapy targeting accuracy, normal tissue avoidance, and conformality of target-tissue coverage will be achieved through the use of 4D real-time tracking which is derived by deformably registering daily MR and planning MR (MRsim) and Computed Tomography Simulator (CTsim) with advanced non-rigid image-registration tools.

Conditions

Interventions

DEVICE

ViewRay MRI

ViewRay Magnetic Resonance Imaging

RADIATION

Stereotactic Body Radiation Therapy Boost

In the (week 5), all patients will have a week 5 MRI and Four-dimensional computed tomography (4D CT) for purposes of planning Phase II boost. Gross tumors \< 5 cm will receive a MR-based adaptive replanning Stereo boost of 80 Gy - 90 Gy (20 Gy-30 Gy in 5 fractions). Gross tumors \< 5cm will receive an MR-based adaptive replan fractionated boost to 74 Gy at 2.4 Gy/day. Individualized radiation therapy prescription to primary tumor will maintain organs at risk (OAR) constraints to lung including mean lung dose (MLD) \< 20 Gy with V20 \< 37%. Simultaneously, MRI-based adaptive replanning boost of 12 Gy in 5 fractions (2.4 Gy/day) will be given to gross lymph nodes. Final doses prescribed will be limited by doses to all OARs.

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Adrian Ishkanian, MD · University of Miami

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-31
Primary Completion
2017-08-08
Completion
2017-08-08
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02950792 on ClinicalTrials.gov