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

NCT02053285 | Completed

• 2 other identifiers: Dual-Energy Tomogr. | 1205150212051502
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer Stage III

Outcome Measures

Primary Outcomes (1)

• 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

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, 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 Design

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

Study Record Dates

• First Submitted: January 23, 2014
• First Posted: February 3, 2014
• Study Start: January 1, 2014
• Primary Completion: May 1, 2019
• Study Completion: February 20, 2020
• Last Updated: September 23, 2022

Record last verified: 2022-09

Locations

US (1)