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

Non-small Cell Lung Cancer Stage III Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02053285
• Other study ID #: Dual-Energy Tomogr. | 12051502
• Secondary ID: 12051502
• Status: Completed
• Start date: January 2014
• Est. completion date: February 20, 2020

Study information

• Verified date: September 2022
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 20, 2020
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer Stage III

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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