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Completed

NCT Number: NCT02053285

Pilot Study of a Novel Type of CT Scan to Assess Treatment Response During Chemoradiotherapy for 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.

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Key information

Conditions

Non-small Cell Lung Cancer Stage III Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
Feb 3, 2014
Registry last updated
Sep 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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