NCT02722109

Brief Summary

Researchers want to compare proton stopping ratios, used for proton beam therapy planning, calculated based on single energy CT and dual energy CT images; with the intension of improve upon the proton range determination.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2016

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 29, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 10, 2018

Status Verified

January 1, 2018

Enrollment Period

1.3 years

First QC Date

March 15, 2016

Last Update Submit

January 9, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Stopping power ratio differences

    For each patient the stopping power will be calculated based on both single and dual energy CT. The treatment of the patient will not be affected in any way of this study, the patient will receive the same treatment whether or not the patient volunteers to participate in this study. And the outcome of the calculations performed in this study will have no influence for the patient. The calculations of the stopping power differences for each patient will as far as possible be done right after acquisition of the CT images, but the exact time point is not important. We will set as a deadline that the calculation for each patient is done within 2 months of acquisition of the CT images of the patient. The entire study will be finished within 2 years, and the results will be tried published in a peer-reviewed journal.

    2 months

Interventions

No intervention will be done

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Patients with a identified tumor referred to curativ intended external beam radiotherapy * Patients, for who are scheduled for a control CT scan during their treatment course * Patients above 18 years of age * Participation will take place on a voluntary basis It is estimated that annually around 1,000 patients will meet the above inclusion criteria

You may qualify if:

  • Cancer patients who are scheduled for a control CT scan

You may not qualify if:

  • Under 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • Engelsman M, Schwarz M, Dong L. Physics controversies in proton therapy. Semin Radiat Oncol. 2013 Apr;23(2):88-96. doi: 10.1016/j.semradonc.2012.11.003.

    PMID: 23473685BACKGROUND
  • Knopf AC, Lomax A. In vivo proton range verification: a review. Phys Med Biol. 2013 Aug 7;58(15):R131-60. doi: 10.1088/0031-9155/58/15/R131. Epub 2013 Jul 17.

    PMID: 23863203BACKGROUND
  • Johnson TR. Dual-energy CT: general principles. AJR Am J Roentgenol. 2012 Nov;199(5 Suppl):S3-8. doi: 10.2214/AJR.12.9116.

    PMID: 23097165BACKGROUND
  • Hunemohr N, Krauss B, Tremmel C, Ackermann B, Jakel O, Greilich S. Experimental verification of ion stopping power prediction from dual energy CT data in tissue surrogates. Phys Med Biol. 2014 Jan 6;59(1):83-96. doi: 10.1088/0031-9155/59/1/83. Epub 2013 Dec 12.

    PMID: 24334601BACKGROUND
  • Bourque AE, Carrier JF, Bouchard H. A stoichiometric calibration method for dual energy computed tomography. Phys Med Biol. 2014 Apr 21;59(8):2059-88. doi: 10.1088/0031-9155/59/8/2059. Epub 2014 Apr 2.

    PMID: 24694786BACKGROUND
  • Hall EJ. Henry S. Kaplan Distinguished Scientist Award 2003. The crooked shall be made straight; dose-response relationships for carcinogenesis. Int J Radiat Biol. 2004 May;80(5):327-37. doi: 10.1080/09553000410001695895.

    PMID: 15223765BACKGROUND
  • Paganetti H. Range uncertainties in proton therapy and the role of Monte Carlo simulations. Phys Med Biol. 2012 Jun 7;57(11):R99-117. doi: 10.1088/0031-9155/57/11/R99. Epub 2012 May 9.

  • Hudobivnik N, Schwarz F, Johnson T, Agolli L, Dedes G, Tessonnier T, Verhaegen F, Thieke C, Belka C, Sommer WH, Parodi K, Landry G. Comparison of proton therapy treatment planning for head tumors with a pencil beam algorithm on dual and single energy CT images. Med Phys. 2016 Jan;43(1):495. doi: 10.1118/1.4939106.

  • Hansen DC, Seco J, Sorensen TS, Petersen JB, Wildberger JE, Verhaegen F, Landry G. A simulation study on proton computed tomography (CT) stopping power accuracy using dual energy CT scans as benchmark. Acta Oncol. 2015;54(9):1638-42. doi: 10.3109/0284186X.2015.1061212. Epub 2015 Jul 29.

  • Yang M, Virshup G, Clayton J, Zhu XR, Mohan R, Dong L. Theoretical variance analysis of single- and dual-energy computed tomography methods for calculating proton stopping power ratios of biological tissues. Phys Med Biol. 2010 Mar 7;55(5):1343-62. doi: 10.1088/0031-9155/55/5/006. Epub 2010 Feb 10.

  • Schneider U, Pedroni E, Lomax A. The calibration of CT Hounsfield units for radiotherapy treatment planning. Phys Med Biol. 1996 Jan;41(1):111-24. doi: 10.1088/0031-9155/41/1/009.

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Cai Grau, Professor

    Aarhus University Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.Sc., PhD student

Study Record Dates

First Submitted

March 15, 2016

First Posted

March 29, 2016

Study Start

August 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

January 10, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

There is no plan to share data with other centers