| CTRI Number |
CTRI/2019/01/017294 [Registered on: 28/01/2019] Trial Registered Prospectively |
| Last Modified On: |
23/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To provide optimized radiation level values for head & neck and pelvic cancer radiotherapy CT Planning. |
|
Scientific Title of Study
|
Establishing diagnostic reference levels and optimization of radiation dose for head and neck and pelvic computed tomography protocols in radiation therapy planning |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
shreekripa |
| Designation |
Asst. Prof in Medical Physics |
| Affiliation |
MAHE |
| Address |
Dept of Radiotherapy and Oncology, SOAHS, KMC, MAHE, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9844990988 |
| Fax |
|
| Email |
rao.shreekripa@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
shreekripa |
| Designation |
Asst. Prof in Medical Physics |
| Affiliation |
MAHE |
| Address |
Dept of Radiotherapy and Oncology, SOAHS, KMC, MAHE, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9844990988 |
| Fax |
|
| Email |
rao.shreekripa@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
shreekripa |
| Designation |
Asst. Prof in Medical Physics |
| Affiliation |
Manipal Academy of Higher Education (MAHE) |
| Address |
Dept of Radiotherapy and Oncology, SOAHS, KMC, Manipal Academy of Higher Education, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9844990988 |
| Fax |
|
| Email |
rao.shreekripa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Source is Grants by The Director,
R&DD, AERB
Niyamak Bhavan,
Anushakti Nagar,
Mumbai-400 094.
Application submitted to AERB |
|
|
Primary Sponsor
|
| Name |
Atomic Energy Regulatory board AERB |
| Address |
The Director,
R&DD, Atomic Energy Regulatory board (AERB),
Niyamak Bhavan,
Anushakti Nagar,
Mumbai-400 094.
|
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shreekripa |
Kasturba Hospital |
Room No 13, CT Room, Dept of Radiotherapy and Oncology, , Kasturba Hospital, KMC, MAHE, Manipal Udupi KARNATAKA |
9844990988
rao.shreekripa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KH and KMC Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D||Radiation Therapy, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Cancer patients referred for CT head and neck and pelvic region with age 18 and above
|
|
| ExclusionCriteria |
| Details |
Un co-operative patients, Patients with dental fillings, Patients with metal prosthesis. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Standardization of Radiotherapy Planning CT head and Neck and pelvic protocol and optimization of dose can be achieved by using the reference DRLs. |
Within 1.5 years of time outcome will be assessed and estimated |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study will be useful in reduction of radiation-induced effects. |
Within 1.5 years of time the outcome will be assessed and estimated |
|
|
Target Sample Size
|
Total Sample Size="215" Sample Size from India="215"
Final Enrollment numbers achieved (Total)= "430"
Final Enrollment numbers achieved (India)="430" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
06/02/2019 |
| Date of Study Completion (India) |
31/01/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="4" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
2 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Study Procedure Before initiating scan, the participant will be explained about the study and written informed consent will be obtained. The age and sex of the participants will be recorded, the following parameters will be collected from CT console for CT examination of head and neck and pelvic such as Tube potential, Tube current, Scan time, Rotation time, Slice thickness, Slice beam collimation, Pitch, Total slices, Field of view, start couch level and end couch level, Reconstruction algorithm that will be used. The patients will be in supine position on flat couch and immobilization device fixed to particular area of scan with reference markers, head first into the gantry. Centre the table height such that the external auditory meatus is at the center of the gantry. Scanning will be performed using present Onco scan protocol. CT dose quantities The two dosimetric quantities namely CTDIvol and DLP will be recorded from dose info for each patient at the end of scan from CT console. CTDIvol will be given in milligray (mGy) and describes the average dose for a volume in either sequential or a helical sequence. DLP will be given in milligray centimeters (mGy.cm) and it is combination of CTDIvol and the scan length that described the total radiation dose received by the patients undergoing CT scans. Effective dose will be calculated using formula: E= k x DLP E= effective dose, K= conversion factor, DLP= Dose Length Product Phase II: Study Procedure Optimizing CT radiation dose with respect to CT acquisition parameters would ideally accomplished by conducting the studies based on observer. Initially this can be performed by acquiring CT image of Phantom with different combination of kV and mAs. To find balance between CT image quality and radiation dose, the scans will be acquiring with a Catphan 503 at specified parameters like Rotation time – 0.5 s/1sec Slice thickness – 2.5 mm/ 3mm / 5mm Pitch – 0.813 mAs and kV – all combinations available in CT scanner After CT acquisition the data will be reconstructed using different algorithms. The reconstructed images will be reviewed by experienced Oncologists and Medical Physicists. By using optimal parameters obtained by analysis of phantom data will be used to create protocols based on optimum parameters. |