Dual-Energy CT on Plan Quality, Dose-delivery Accuracy, and Simulated Outcomes of Patients Treated With Proton or Photon Therapy

NCT03403361 | Terminated Results DMC FDA Device

• 2 other identifiers: 2017111491R01CA212638
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this protocol is to refine the accuracy of proton beam therapy (PT) by the use of dual energy computed tomography (DECT), in conjunction with novel iterative image reconstruction algorithms, to more precisely determine the tissue properties through which the proton beam path travels.

Conditions

Lung Cancer; Brain Cancer; Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Dose Difference in 99% Planning Target Volume (PTV) Coverage Between Single Energy CT and Dual Energy CT

  Day 1

Study Arms (1)

Dual-Energy CT scan

EXPERIMENTAL

Patients enrolling in this study will undergo additional sequential DECT scan in addition to their routine SECT or DECT scan.

Device: Siemens Somatom Definition Edge; Device: Philips Brilliance Big Bore CT/simulator

Interventions

Siemens Somatom Definition Edge DEVICE

In addition to acquiring medically-routine datasets, each patient subject will be scanned sequentially at two or three different beam energies (80 or 90 kVp, 100 kVp, 120 kVp, and 140 kVp) as part of this research study.

Dual-Energy CT scan

Philips Brilliance Big Bore CT/simulator DEVICE

In addition to acquiring medically-routine datasets, each patient subject will be scanned sequentially at two or three different beam energies (80 or 90 kVp, 100 kVp, 120 kVp, and 140 kVp) as part of this research study.

Dual-Energy CT scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of histologically proven primary or metastatic cancer requiring thoracic radiation therapy OR radiation therapy to the head and neck or brain
• At least 18 years of age.
• Planning to undergo proton or photon beam radiation therapy as part of the clinical management of the diagnosed cancer.
• Able to understand and willing to sign an IRB-approved written informed consent document.

You may not qualify if:

• Implanted metallic objects in the region to be scanned excepting dental prostheses
• IV or oral contrast medium within 24 hours prior to DECT image acqusition
• Pregnant.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Lung Neoplasms; Brain Neoplasms; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. Clifford Robinson
• Organization: Washington University School of Medicine

clifford.robinson@wustl.edu

314-362-8567

Study Officials

• Clifford Robinson, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 18, 2018
• Study Start: June 1, 2018
• Primary Completion: August 11, 2022
• Study Completion: August 11, 2022
• Last Updated: March 1, 2024
• Results First Posted: March 1, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)