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Clinical Trials/CTRI/2024/03/063947
CTRI/2024/03/063947Not yet recruitingNot Applicable

CT based Radiomic analysis of radiation induced xerostomia in head and neck cancer radiotherapy patients

Manipal Academy of Higher Education1 site in 1 country10 target enrollmentStarted: March 17, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
10
Locations
1
Primary Endpoint
Radiomic features such as shape based, first order, GLCM, GLRLM, GLSZM, NGDTM, GLDM

Study Overview

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

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Patients with head and neck cancer treated with curative intent on follow-up without xerostomia CT images with motion artifacts.

Outcomes

Primary Outcomes

Radiomic features such as shape based, first order, GLCM, GLRLM, GLSZM, NGDTM, GLDM

Time Frame: Radiomic features extraction and analysis - once in 4 weeks

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Saikiran P

Manipal College of Health Professions/Manipal Academy of Higher Education

Study Sites (1)

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