Validation of Low Dose CT for Diagnosis of Lung Nodules

NCT ID: NCT03681873

Last Updated: 2022-08-15

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

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-30

Study Completion Date

2021-09-07

Brief Summary

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The investigators have developed an extremely low dose computed tomography (CT) protocol that on preliminary testing has an effective dose in the range of two chest radiographs. The investigators plan to test this exam in patients with known or suspected cancer undergoing clinically indicated chest CT.

Detailed Description

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Conditions

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Cancer Metastasis to Lung

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Study Group

Patients will receive both the clinically indicated and extremely low dose exams

Group Type EXPERIMENTAL

Extremely Low Dose CT

Intervention Type DIAGNOSTIC_TEST

Patients undergoing a clinically indicated chest CT will also undergo the extremely low dose CT

Interventions

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Extremely Low Dose CT

Patients undergoing a clinically indicated chest CT will also undergo the extremely low dose CT

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Pediatric and young adult patients (ages 4 to \<21 years)
* Known or suspected malignancy other than lymphoma
* Undergoing clinically indicated CT of the chest

Exclusion Criteria

* Pregnancy identified by routine Department of Radiology verbal screening
* Prior enrollment in the same study (no patient will be enrolled more than once)
* Inability to provide consent and/or assent
* Lymphoma
Minimum Eligible Age

4 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cincinnati Children's Hospital Medical Center Burnet Campus

Cincinnati, Ohio, United States

Site Status

Countries

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United States

References

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Thapaliya S, Gilligan LA, Brady SL, Anton CG, Crotty EJ, Nasser MP, Geller JI, Pressey JG, Zhang B, Dillman JR, Trout AT. Comparison of 0.3-mSv CT to Standard-Dose CT for Detection of Lung Nodules in Children and Young Adults With Cancer. AJR Am J Roentgenol. 2021 Dec;217(6):1444-1451. doi: 10.2214/AJR.21.26183. Epub 2021 Jul 7.

Reference Type DERIVED
PMID: 34232694 (View on PubMed)

Other Identifiers

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2018-6122

Identifier Type: -

Identifier Source: org_study_id

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