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

Sponsor
Rush University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02053285
Collaborator
(none)
9
Enrollment
1
Location
73.6
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    9 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Pilot Study of Dual-Energy Computed Tomography in Stage III Non-Small Cell Lung Cancer
    Study Start Date :
    Jan 1, 2014
    Actual Primary Completion Date :
    May 1, 2019
    Actual Study Completion Date :
    Feb 20, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Change in the tumor's maximum iodine related attenuation (IRA) from baseline to on-treatment DECT. [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.

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rush University Medical Center Chicago Illinois United States 60612

    Sponsors and Collaborators

    • Rush University Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Rush University Medical Center
    ClinicalTrials.gov Identifier:
    NCT02053285
    Other Study ID Numbers:
    • Dual-Energy Tomography Pilot
    • 12051502
    First Posted:
    Feb 3, 2014
    Last Update Posted:
    Jan 20, 2021
    Last Verified:
    Jan 1, 2021
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Jan 20, 2021