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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02722109
Other study ID # VEK52217
Secondary ID
Status Terminated
Phase N/A
First received March 15, 2016
Last updated January 9, 2018
Start date August 2016
Est. completion date December 2017

Study information

Verified date January 2018
Source Aarhus University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 14
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Cancer patients who are scheduled for a control CT scan

Exclusion Criteria:

- Under 18 years of age

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention
No intervention will be done

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Aarhus University Hospital

References & Publications (11)

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. Erratum in: Phys Med Biol. 2014 Sep 21;59(18):5611-2. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Hansen DC, Seco J, Sørensen 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 — View Citation

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 i — View Citation

Hünemohr N, Krauss B, Tremmel C, Ackermann B, Jäkel 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. — View Citation

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

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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: 1 — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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