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CompletedNCT06233396Updated Jan 31, 2024

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

An observational study in the Diffenence of Different Detector Row 4DCT,Especially in Artifects,Radiation Dose and Target Volume, sponsored by Tianjin Medical University Cancer Institute and Hospital. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-31.

Sponsored by Tianjin Medical University Cancer Institute and Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
33
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • the Diffenence of Different Detector Row 4DCT,Especially in Artifects,Radiation Dose and Target Volume
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In context

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 484 studies on the registry; 286 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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

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;
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
33 participants (actual)
Patient registry
No

Interventions

  • OtherExtra 4DCT scan

    Extra 4DCT scan after routine simulation

06

What researchers measure

Primary outcomes

  1. target volume

    4DCT ITV delineation

    Time frame: 2023.4-2024.1

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Study locations

1 site
  • 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
    Tianjin, Tianjin 300381, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06233396
Lead sponsor
Tianjin Medical University Cancer Institute and Hospital
Responsible party
Sponsor
First posted
Jan 31, 2024
Start date
Mar 1, 2023
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023
Last update
Jan 31, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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