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

NCT ID: NCT02053285

Last Updated: 2022-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2020-02-20

Brief Summary

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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.

Detailed Description

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Conditions

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Non-small Cell Lung Cancer Stage III

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rush University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rush University Medical Center

Chicago, Illinois, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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12051502

Identifier Type: OTHER

Identifier Source: secondary_id

Dual-Energy Tomogr. | 12051502

Identifier Type: -

Identifier Source: org_study_id

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