Feasibility Study of Radiation Therapy With Wide Detector 4DCT Scanning for Primary or Metastatic Lung Cancer

Uncertainty in Lung SBRT Simulation Based on 4DCT With Different Detector Widths

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 Overview

• Status: Completed
• Conditions: the Diffenence of Different Detector Row 4DCT，Especially in Artifects，Radiation Dose and Target Volume
• Intervention / Treatment: Other: Extra 4DCT scan

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300381
      • Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key laboratory of Cancer Prevention and Therapy, Tianjin's Clinical Research Center for Cancer, Huan-Hu-Xi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients with primary or metastatic tumors in the lungs diagnosed by PETCT or puncture biopsy, in good general condition, who have completed gold standard implantation and are proposed to undergo SBRT

Description

Inclusion Criteria:

• 1. Voluntarily participate in and sign the informed consent in person. 2. Over 18 years old, gender unlimited; 3. After imaging diagnosis of primary lung cancer or space-occupying lung lesions with oligometastases, MDT decided to treat SBRT 4. Clinical stage IA-IV (cT1-4N1-3M0-1); 5. No serious abnormality of blood system, heart, lung, liver, kidney function and immune deficiency; 6. 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; 7. Hemoglobin ≥100g/L, WBC≥4×109/L, neutrophils ≥1.5×109/L, platelets ≥100×109/L 8. 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; 9. Serum creatinine ≤1.5 times the upper limit of normal value; 10. The willingness of men or women of childbearing age to use contraception in the trial; 11. Physical condition score ECOG level 0 ~ 2; 12. Expected survival >3 months;

Exclusion Criteria:

• 1. Patients could not tolerate or were unwilling to undergo CT examination; 2. The primary lesion has undergone surgery or radiotherapy or chemotherapy or targeted or immunotherapy; 3. Subjects who have received other drug trials within the last 1 month; 4. People with severe allergic history or idiosyncrasies; 5. Patients with a history of severe lung or heart disease; 6. Severe comorbidities, such as uncontrolled hypertension, heart failure, etc.; 7. Pregnant or lactating women; 8. Previous history of malignant tumor; 9. Refusal or inability to sign informed consent to participate in the trial; 10. Currently or planning to participate in other clinical trials;

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
target volume	4DCT ITV delineation	2023.4-2024.1

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: January 23, 2024
• First Posted (Actual): January 31, 2024

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: bc2022235

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No