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OpenTrials
Completed

NCT Number: NCT04702607

Functional Lung Imaging With DECT and 4DCT

The basic premise of this pilot study is to enroll 40 patients over 3 years who have Stage II, III, or IV non-small cell lung cancer and are planned for definitive treatment with concurrent chemoradiation where a contrast enhanced 4DCT is planned.

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Abamson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients have histologic diagnosis of non-small cell lung cancer
  • Patients have AJCC stage II, III or IV disease were the plan is to receive definitive concurrent chemoradiation to 60 Gy or higher
  • Age > 18 years of age
  • Patients are able to provide informed consent
  • No additional lung radiation is planned until after the 2nd CT on this study (i.e. patient does not have a solitary pulmonary nodule or second primary that the plan is to undergo SBRT)
  • Patient must have adequate kidney function to receive IV contrast (following institutional policy supplied by radiology). The cutoff level for serum creatinine is 1.6 mg/dL
  • Negative urine pregnancy test before every CT scan

Exclusion criteria

  • Allergy to IV iodine contrast
  • Severe claustrophobia
  • Further thoracic radiation therapy is planned.

Treatment and study plan

contrast enhanced 4DCT

Procedure

Functional Lung Imaging with DECT and 4DCT

Primary outcomes

  1. evaluate the reproducibility of PBV DECT imaging and 4DCT derived lung ventilation for evaluating lung function

    Time frame: 3 years

  2. correlate changes of PBV DECT and 4DCT lung function images seen at ~6 months with radiation dose and with patient reported outcome quality of life

    Time frame: 3 years

Secondary outcomes

  1. • To propose a novel biologic (i.e. functional) dose volume algorithm to reduce PBV and 4DCT lung function changes

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

Pilot Study to Assess Lung Function Using Perfusion Blood Volume Dual Energy CT and 4DCT Derived Lung Ventilation Imaging

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 11, 2021
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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