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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025273
Receipt No. R000029064
Scientific Title Establishment of adaptive radiotherapy by deformable image registration using planning-CT and cone-beam CT
Date of disclosure of the study information 2016/12/15
Last modified on 2017/12/18

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Basic information
Public title Establishment of adaptive radiotherapy by deformable image registration using planning-CT and cone-beam CT
Acronym Establishment of adaptive radiotherapy by deformable image registration using planning-CT and cone-beam CT
Scientific Title Establishment of adaptive radiotherapy by deformable image registration using planning-CT and cone-beam CT
Scientific Title:Acronym Establishment of adaptive radiotherapy by deformable image registration using planning-CT and cone-beam CT
Region
Japan

Condition
Condition Head and neck cancer, prostate cancers, lung cancer, liver cancer, cervical cancer
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate deformable image registration using planning-CT and cone-beam CT for adaptive radiotherapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes This study compares dose distribution with CT and CBCT. We evaluate the clinical efficacy of this method based on these results.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 We use imaging data collected for IGRT during treatment, such as cone beam CT. Therefore, it is non-invasive study.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria Patients scheduled to be treated with image guided radiotherapy at our facility are selected.
Key exclusion criteria Except above condition.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriko Kotoura
Organization Hyogo College of Medicine College Hospital
Division name Department of Radiological Technology
Zip code
Address 1-1, Mukogawa-cho, Nishinomiya-shi, Hyogo, Japan
TEL 0798-45-6259
Email rt4562@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masao Tanooka
Organization Hyogo College of Medicine College Hospital
Division name Department of Radiological Technology
Zip code
Address 1-1, Mukogawa-cho, Nishinomiya-shi, Hyogo, Japan
TEL 0798-45-6259
Homepage URL http://www.hyo-med.ac.jp/department/radd/page0103.html
Email tanooka@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization Hyogo College of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications https://www.scirp.org/journal/PaperInformation.aspx?PaperID=73421
Number of participants that the trial has enrolled
Results
Deformable image registration (DIR) has been an important component in adaptive radiotherapy (ART). Our goal was to examine the accuracy of ART using the dice similarity coefficient (DSC) and to determine the optimal timing of replanning. A total of 22 patients who underwent volume modulated arc therapy (VMAT) for head and neck (H&N) cancers were prospectively analyzed. The planning target volume (PTV) was to receive a total of 70 Gy in 33 fractions. A second planning CT scan (rescan) was performed at the 15th fraction. The DSC was calculated for each structure on both CT scans. The continuous variables to predict the need for replanning were assessed. The optimal cut-off value was determined using receiver operating characteristic (ROC) curve analysis. In the correlation between body weight loss and DSC of each structure, weight loss correlated negatively with DSC of the whole face (rs = -0.45) and the face surface (rs = -0.51). Patients who required replanning tended to have experienced rapid weight loss. The threshold DSC was 0.98 and 0.60 in the whole face and the face surface, respectively. Patients who showed low DSC in the whole face and the face surface required replanning at a significantly high rate (P < 0.05 and P < 0.01). Weight loss correlated with DSC in both the whole face and the face surface (P < 0.05 and P < 0.05). The DSC values in the face predicted the need for replanning. In addition, weight loss tended to correlate with DSC. DIR during ART was found to be a useful tool for replanning.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 20 Day
Last follow-up date
2017 Year 12 Month 14 Day
Date of closure to data entry
2017 Year 12 Month 14 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 14 Day
Last modified on
2017 Year 12 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029064

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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