Functional Lung Imaging With DECT and 4DCT

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04702607
• Other study ID #: UPCC 18520
• Status: Recruiting
• Start date: January 2, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Abramson Cancer Center at Penn Medicine
• Contact: Ching Lai
• Phone: 267-250-9244
• Email: ching.lai[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Intervention

Procedure:
• contrast enhanced 4DCT
Functional Lung Imaging with DECT and 4DCT

Locations

Country	Name	City	State
United States	Abamson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluate the reproducibility of PBV DECT imaging and 4DCT derived lung ventilation for evaluating lung function		3 years
Primary	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		3 years
Secondary	• To propose a novel biologic (i.e. functional) dose volume algorithm to reduce PBV and 4DCT lung function changes		3 years