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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02053285

Enrollment

Registered

2014-02-03

Start date

2014-01-31

Completion date

2020-02-20

Last updated

2022-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer Stage III

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results