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

September 21, 2022 updated by: Rush University Medical Center

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

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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.
Time Frame: 0, 1, 3, 5
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

This is where you will find people and organizations involved with this study.

Sponsor

Rush University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • Dual-Energy Tomogr. | 12051502
  • 12051502 (Other Identifier: Rush University Medical Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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