Validation of Low Dose CT for Diagnosis of Lung Nodules

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Metastasis to Lung; Cancer

Treatments: Diagnostic Test: Extremely Low Dose CT

Study type: Interventional

Funder types: Other

Identifiers

NCT03681873

2018-6122

Details and patient eligibility

About

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.

Enrollment: 78 patients

Sex: All

Ages: 4 to 20 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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78 participants in 1 patient group

Study Group

Experimental group

Description:

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

Treatment:

Diagnostic Test: Extremely Low Dose CT