Functional Lung Imaging With DECT and 4DCT

NCT04702607 | Completed DMC

• 1 other identifier: UPCC 18520
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

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

  3 years

• 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 Outcomes (1)

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

  3 years

Study Arms (1)

contrast enhanced 4DCT

Procedure: contrast enhanced 4DCT

Interventions

contrast enhanced 4DCT PROCEDURE

Functional Lung Imaging with DECT and 4DCT

contrast enhanced 4DCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abamson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Steven Feigenberg, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2021
• First Posted: January 11, 2021
• Study Start: January 2, 2021
• Primary Completion: October 5, 2024
• Study Completion: October 5, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)