Functional Lung Imaging With DECT and 4DCT

• Sponsor: Abramson Cancer Center of the University of Pennsylvania (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04702607
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

The basic premise of this pilot study is to enroll 40 patients over 1.5 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..

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer	Procedure: contrast enhanced 4DCT

Study Design

• Study Type: Observational
• Anticipated Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Pilot Study to Assess Lung Function Using Perfusion Blood Volume Dual Energy CT and 4DCT Derived Lung Ventilation Imaging
• Actual Study Start Date: Jan 2, 2021
• Anticipated Primary Completion Date: Jan 2, 2023
• Anticipated Study Completion Date: Jan 2, 2023

Arms and Interventions

Arm	Intervention/Treatment
contrast enhanced 4DCT	Procedure: contrast enhanced 4DCT; Functional Lung Imaging with DECT and 4DCT

Outcome Measures

Primary Outcome Measures

1. evaluate the reproducibility of PBV DECT imaging and 4DCT derived lung ventilation for evaluating lung function [1.5 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 [1.5 years]

Secondary Outcome Measures

1. • To propose a novel biologic (i.e. functional) dose volume algorithm to reduce PBV and 4DCT lung function changes [1.5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients have histologic diagnosis of non-small cell lung cancer

• Patients have AJCC stage 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 3rd 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abamson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Abramson Cancer Center of the University of Pennsylvania

Investigators

• Principal Investigator: Steven Feigenberg, MD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abramson Cancer Center of the University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT04702607
• Other Study ID Numbers: UPCC 18520
• First Posted: Jan 11, 2021
• Last Update Posted: Aug 17, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Aug 17, 2021