Tokyo, Nov. 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063508) titled 'A Prospective Observational Study on the Feasibility of Radiotherapy Treatment Planning Using Photon-Counting CT' on Nov. 4.
Study Type:
Observational
Primary Sponsor:
Institute - Wakayama medical university
Condition:
Condition - Malignant neoplasms
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - Photon-counting CT (PCCT) offers high spatial resolution, low image noise, and spectral information, which may improve the accuracy of target and organ-at-risk delineation and dose calculation in radiotherapy planning.
This single-arm, prospective observational basket study includes patients eligible for definitive radiotherapy, intensity-modulated radiation therapy (IMRT), or stereotactic radiotherapy (SBRT/SRT/SRS) across multiple anatomical sites. The study aims to assess the feasibility of completing treatment plans of clinically acceptable quality using only PCCT simulation images and to evaluate the imaging and treatment planning characteristics of PCCT.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients must meet all of the following criteria:
1) A clinical decision has been made to administer definitive radiotherapy, intensity-modulated radiation therapy (IMRT), or stereotactic radiotherapy (SBRT, SRT, or SRS).
2) CT simulation (CT-S) is required for radiotherapy planning.
3) The planned treatment site is one of the following: intracranial (brain), head and neck, thorax, abdomen (liver, biliary tract, or pancreas), pelvis, or bone/spine. Both metastatic and primary brain tumors are eligible.
4) Age 18 years or older at enrollment.
5) Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 2.
6) Written informed consent to participate in the study has been obtained from the patient.
Key exclusion criteria - Patients meeting any of the following criteria will be excluded:
1) Pregnant, breastfeeding, or potentially pregnant.
2) Unable to safely undergo CT simulation using PCCT because of difficulty maintaining the required position.
3) Radiotherapy is intended solely for palliation.
Target Size - 160
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 10 Month 06 Day
Date of IRB - 2026 Year 11 Month 02 Day
Anticipated trial start date - 2026 Year 11 Month 09 Day
Last follow-up date - 2029 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072687
Disclaimer: Curated by HT Syndication.