| CTRI Number |
CTRI/2024/03/063947 [Registered on: 11/03/2024] Trial Registered Prospectively |
| Last Modified On: |
08/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
CT image analysis for head and neck cancer patients with dry mouth after radiation treatment |
|
Scientific Title of Study
|
CT based Radiomic analysis of radiation induced xerostomia in head and neck
cancer radiotherapy patients |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saikiran P |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions/Manipal Academy of Higher Education |
| Address |
Department of Medical Imaging Technology, Manipal College of Health Professions, Manipal Academy of Higher Education, Udupi, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9791197526 |
| Fax |
|
| Email |
saikiran.p@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saikiran P |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions/Manipal Academy of Higher Education |
| Address |
Department of Medical Imaging Technology, Manipal College of Health Professions, Manipal Academy of Higher Education, Udupi, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9791197526 |
| Fax |
|
| Email |
saikiran.p@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saikiran P |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions/Manipal Academy of Higher Education |
| Address |
Department of Medical Imaging Technology, Manipal College of Health Professions, Manipal Academy of Higher Education, Udupi, Karnataka, India
Udupi
KARNATAKA
576104
India |
| Phone |
9791197526 |
| Fax |
|
| Email |
saikiran.p@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical college and hospital, Manipal |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
MAHE, Tiger circle, Madhav Nagar, Manipal, Karnataka, India -576104 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saikiran P |
Kasturba Medical College and Hospital |
Room No:2, 128 slice Incisive CT scanner, Department of Radiodiagnosis and Imaging,Kasturba Medical College and Hospital, Manipal, Udupi, Karnataka 576104
Udupi
KARNATAKA |
9791197526
saikiran.p@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Hospital, Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C041||Malignant neoplasm of lateral floor of mouth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with head and neck cancer treated with curative intent on follow-up of at least 6 months
Clinically no evidence of recurrence disease
No active treatment of cancer
Non-metastatic disease at the time of follow-up |
|
| ExclusionCriteria |
| Details |
Patients with head and neck cancer treated with curative intent on follow-up without xerostomia
CT images with motion artifacts |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Radiomic features such as shape based, first order, GLCM, GLRLM, GLSZM, NGDTM, GLDM |
Radiomic features extraction and analysis - once in 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Xerostomia is common side effect of patients with head and neck cancer who will
undergo Intensity modulated radiotherapy (IMRT) due to exposure of parotid glands
to radiation. It affects the quality of life (QOL) of individual. Xerostomia is graded
subjectively using Radiation Therapy Oncology Group (RTOG) scoring criteria.
Radiomics is currently used in diagnosis, prognosis prediction. The objective of the
study is to identify the significant CT based radiomic features useful for assessing
xerostomia in head and neck cancer patients treated with IMRT. The patients with
head and neck cancers who had undergone radiotherapy treatment and coming for
follow up at least 6 months - 1 year will be evaluated and patients with xerostomia
grading from 1-4 will be referred for CT Neck. The radiomic features of parotid
gland will be extracted from pre and post radiotherapy images. Wilcoxon
signed‑rank test will be performed to assess the significant changes in CT radiomic
features of parotid glands in post radiotherapy relative to pre radiotherapy images |