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Cancer(DUAL)NCT02722109

Dual Energy CT: A New Method for Better Dose Calculation in Proton Beam Therapy

An observational study of Cancer, run by Aarhus University Hospital.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
How many people
14 participants
Where
No sites listed yet
Study dates
Aug 2016to Dec 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • Cancer patients who are scheduled for a control CT scan

Who cannot join

  • Under 18 years of age

About this study

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.

Read the detailed description

The main goal of this study is to compare proton stopping ratios, used for proton beam therapy planning, calculated based on single energy CT and dual energy CT images.

The calculation methods for proton stopping power ratios differs for the two types of CT images, and researchers want to investigate if the proton stopping power ratio can be estimated more accurately by using dual energy CT. A more accurate stopping power ratio calculation gives a more accurate proton range determination in the patient tissue, which again will lead to a better knowledge of the dose distribution in the patient undergoing cancer treatment with proton beam irradiation.

Knowing the accurate dose distribution allows for an uncertainty margin reduction around the tumor, which will result in less normal tissue being irradiated and thereby the risk of side effects is reduced without risking an under-dosage of the tumor.

Conditions
Cancer
Being tested
No intervention
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    No intervention will be done

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionDec 2017
  4. Study completionDec 2017

Why it stopped: Not enough patients signed up

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02722109
Sponsor's protocol ID
VEK52217
Acronym
(DUAL)
Status last verified
Jan 2018
First submitted
15 Mar 2016
Last updated
10 Jan 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No: There is no plan to share data with other centers

Publications

  • 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.

    PubMed 23473685

  • 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.

    PubMed 23863203

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

    PubMed 23097165

  • 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.

    PubMed 24334601

  • 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.

    PubMed 24694786

  • Hall EJ; New Collective Author. 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.

    PubMed 15223765

  • 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.

    PubMed 22571913

  • 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.

    PubMed 26745942

  • 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.

    PubMed 26219959

  • 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.

    PubMed 20145291

  • 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.

    PubMed 8685250

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer, run by Aarhus University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Not enough patients signed up). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stopping power ratio differences (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02722109, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2018.

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