NCT03681873

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 24, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

November 30, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2021

Completed
Last Updated

August 15, 2022

Status Verified

August 1, 2022

Enrollment Period

1.8 years

First QC Date

September 18, 2018

Last Update Submit

August 12, 2022

Conditions

CancerMetastasis to Lung

Outcome Measures

Primary Outcomes (1)

  • Diagnostic performance of extremely low dose CT

    Sensitivity

    At time of imaging

Study Arms (1)

Study Group

EXPERIMENTAL

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

Diagnostic Test: Extremely Low Dose CT

Interventions

Extremely Low Dose CTDIAGNOSTIC_TEST

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

Study Group

Eligibility Criteria

Age4 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center Burnet Campus

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

  • 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.

    PMID: 34232694DERIVED

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2018

First Posted

September 24, 2018

Study Start

November 30, 2018

Primary Completion

September 2, 2020

Study Completion

September 7, 2021

Last Updated

August 15, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)