CClinicalTrials.gg
TerminatedNCT03403361Updated Mar 1, 2024Results posted

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

An interventional study of Siemens Somatom Definition Edge and Philips Brilliance Big Bore CT/simulator in Lung Cancer, Brain Cancer and Head and Neck Cancer, sponsored by Washington University School of Medicine. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-01.

Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Diagnostic

Why this study was terminated
Low accrual
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Lung Cancer
  • Brain Cancer
  • Head and Neck Cancer

Browse trials for

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility Criteria:

Inclusion criteria

Inclusion Criteria:

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Dual-Energy CT scan

    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

  • DeviceSiemens Somatom Definition Edge

    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.

  • DevicePhilips Brilliance Big Bore CT/simulator

    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.

05

What researchers measure

Primary outcomes

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

    Time frame: Day 1

06

Results

Posted Mar 1, 2024

Participant flow

Participant flow — Overall Study
MilestoneDual-Energy CT Scan
Started36
Completed20
Not completed16
Withdrew: Not imaged due to issues during the pandemic16

Outcome measures

PrimaryDose Difference in 99% Planning Target Volume (PTV) Coverage Between Single Energy CT and Dual Energy CT
Time frame:
Day 1
Reported as:
Mean · percentage relative to prescribed dose
Dose Difference in 99% Planning Target Volume (PTV) Coverage Between Single Energy CT and Dual Energy CT
percentage relative to prescribed doseDual-Energy CT Scan
Head and Neck Patients0.9 ± 1.8
Lung Patients1.0 ± 2.8

Adverse events

Collected over Adverse events and all-cause mortality were followed for 1 day.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Dual-Energy CT Scan0/20 (0%)0/20 (0%)0/20 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Dual-Energy CT Scan
Median66.5 (22 to 86)
Sex: Female, Male
Sex: Female, Male(Participants)Dual-Energy CT Scan
Female15
Male21
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Dual-Energy CT Scan
Hispanic or Latino2
Not Hispanic or Latino34
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Dual-Energy CT Scan
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American5
White30
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Dual-Energy CT Scan
United States36
07

Study locations

1 site
  • Washington University School of Medicine
    Saint Louis, Missouri 63110, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Oct 5, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03403361
Lead sponsor
Washington University School of Medicine
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jan 18, 2018
Start date
Jun 1, 2018
Primary completion
Aug 11, 2022
Completion
Aug 11, 2022
Results posted
Mar 1, 2024
Last update
Mar 1, 2024

Study contacts

Clifford Robinson, M.D.
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion