NCT06233396CompletedNot Applicable
Uncertainty in Lung SBRT Simulation Based on 4DCT With Different Detector Widths
Tianjin Medical University Cancer Institute and Hospital1 site in 1 country33 target enrollmentStarted: March 1, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- target volume
Study Overview
Brief Summary
Currently there are very few studies using wide-body detectors for 4DCT to determine lung tumor volume and comparing them with conventional detector 4DCT images, and no prospective clinical trials comparing 4DCT images from different width detectors have been queried, therefore, in this study, we will prospectively explore in a body model and patients: 1) the degree of artifacts, tumor volume, and radiation dose of the 4DCT scans performed by different width detectors. differences, and scanning radiation dose. (ii) Whether there are differences in different tumor ITV outlining modalities on 4DCT with different detector widths.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Voluntarily participate in and sign the informed consent in person.
- •Over 18 years old, gender unlimited;
- •After imaging diagnosis of primary lung cancer or space-occupying lung lesions with oligometastases, MDT decided to treat SBRT
- •Clinical stage IA-IV (cT1-4N1-3M0-1);
- •No serious abnormality of blood system, heart, lung, liver, kidney function and immune deficiency;
- •Coagulation function: activated partial thromboplastin time (APTT) < the upper limit of normal 10 seconds, prothrombin time (PT) < the upper limit of normal 3 seconds, plasma fibrinogen 2-4g/L;
- •Hemoglobin ≥100g/L, WBC≥4×109/L, neutrophils ≥1.5×109/L, platelets ≥100×109/L
- •Bilirubin < 1.5 times the upper limit of normal value; Glutamic oxalic aminotransferase (ALT) & Glutamic pyruvic aminotransferase (AST) ≤1.5 times the upper limit of normal value;
- •Serum creatinine ≤1.5 times the upper limit of normal value;
- •The willingness of men or women of childbearing age to use contraception in the trial;
- •Physical condition score ECOG level 0 ~ 2;
- •Expected survival >3 months;
Exclusion Criteria
- •Patients could not tolerate or were unwilling to undergo CT examination;
- •The primary lesion has undergone surgery or radiotherapy or chemotherapy or targeted or immunotherapy;
- •Subjects who have received other drug trials within the last 1 month;
- •People with severe allergic history or idiosyncrasies;
- •Patients with a history of severe lung or heart disease;
- •Severe comorbidities, such as uncontrolled hypertension, heart failure, etc.;
- •Pregnant or lactating women;
- •Previous history of malignant tumor;
- •Refusal or inability to sign informed consent to participate in the trial;
- •Currently or planning to participate in other clinical trials;
Outcomes
Primary Outcomes
target volume
Time Frame: 2023.4-2024.1
4DCT ITV delineation
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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