Pilot Study of a Novel Type of CT Scan to Assess Treatment Response During Chemoradiotherapy for Stage III Non-Small Cell Lung Cancer

Pilot Study of Dual-Energy Computed Tomography in Stage III Non-Small Cell Lung Cancer

Dual-energy CT (DECT) provides information on the blood volume in tumors and lymph nodes. As tumors respond to treatment, preliminary data suggests that the blood volumes changes as well. Investigators are therefore using DECT to test whether it can be used on radiation treatment to rapidly assess response to treatment.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer Stage III

• Study Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with stage III lung cancer treated with chemoradiotherapy or chemoradiotherapy followed by surgery

Description

Inclusion Criteria:

• Patients aged greater than 18 years with a diagnosis of stage III non-small cell lung cancer.
• Planned treatment with either definitive chemoradiotherapy or preoperative chemoradiotherapy followed by surgical resection.
• PET-CT study within 4 weeks of next available DECT study.
• Patients must have measurable primary and nodal disease, defined by at least one lesion (primary and lymph node) greater than 1 cm.
• Kidney function sufficient to tolerate iodine-based CT contrast.
• No allergy to iodine-based contrast.
• Ability to understand and the willingness to sign informed consent.

Exclusion Criteria:

• Participants with a prior history of thoracic radiotherapy.
• Participants may not be receiving any other study agents.
• Inability to tolerate CT contrast
• Pregnant women are excluded from this study because radiotherapy has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with radiotherapy, breastfeeding should be discontinued if the mother is treated with radiotherapy. These potential risks may also apply to other agents used in this study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the tumor's maximum iodine related attenuation (IRA) from baseline to on-treatment DECT.	This change in the maximum IRA will be compared with the change in the maximum standardized uptake value (SUV max) between baseline PET-CT and follow-up PET-CT at 3 months after treatment. For patients undergoing surgery, this change in the maximum IRA will be compared between patients who have a complete pathologic response, and those patients who do not.	0, 1, 3, 5

Collaborators and Investigators

• Sponsor: Rush University Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): February 20, 2020

Study Registration Dates

• First Submitted: January 23, 2014
• First Submitted That Met QC Criteria: January 31, 2014
• First Posted (Estimate): February 3, 2014

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: Dual-Energy Tomogr. | 12051502; 12051502 (Other Identifier: Rush University Medical Center)