NCT02053285

Completed

Pilot Study of a Novel Type of CT Scan to Assess Treatment R...

Rush University Medical Center Source

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Other study identifiers

Sponsor study identifier

Dual-Energy Tomogr. | 12051502

Secondary identifiers

12051502

OTHER · Rush University Medical Center

Study Type

observational

Actual enrollment (reported)

9

Locations

1 country

Sites

1

Timeline

Study Start

January 2014

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

May 2019

Actual (reported)

Study Completion

February 20, 2020

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 9 participants
Study completion date: February 20, 2020
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
January 2014
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
January 23, 2014
Actual (reported)
First Posted
February 3, 2014
Actual (reported)
Primary Completion
May 2019
Actual (reported)
Study Completion
February 20, 2020
Actual (reported)

Last Updated: September 23, 2022
Status Verified: September 2022
Last Update Submitted: September 21, 2022

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

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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.

Sponsors & Collaborators

Rush University Medical Center
Otherlead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Enrollment

9 participants (actual enrollment reported by the registry).

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 2014

Date type not reported

This date has not been verified as actual or estimated.

Phase 2

Unknown

NCT02434081

NIvolumab COmbination With Standard First-line Chemotherapy and Radiotherapy in Locally Advanced Stage IIIA/B Non-Small Cell Lung Carcinoma

Phase 2Completed

NCT04749407

Biomarkers of Stage III Locally Advanced Unresectable Non-small-cell Lung Cancer

Unknown

NCT03743129

Anlotinib After Chemoradiotherapy in Stage III Non-Small-Cell Lung Cancer（ALTER-L029）

Phase 2Completed

NCT03728556

A Study of CS1001 in Subjects With Stage III Non-Small Cell Lung Cancer

Phase 3Completed

NCT05414630

A Study of Envafolimab in Subjects With Stage III Non-Small Cell Lung Cancer

Phase 2Unknown

NCT04728724

Neoadjuvant Immunotherapy for Stage III Non-small Cell Lung Cancer

Phase 2Recruiting

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.

Contact the study team to confirm eligibility.

Primary Completion

May 2019

Actual (reported)

Study Completion

February 20, 2020

Actual (reported)

Last Updated

September 23, 2022

Record last verified: 2022-09

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02053285
Data provider: ClinicalTrials.gov
Source updated: 2022-09-23
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:24:41 UTC

Documents

Informed Consent Form
ICF2015-05-29

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations