CancerNCT03681873
Validation of Low Dose CT for Diagnosis of Lung Nodules
A study testing Extremely Low Dose CT in people with Cancer and Metastasis to Lung, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 20 years
- Conditions the study is for
- Cancer, Metastasis to Lung
- What is being tested?
- Extremely Low Dose CT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2018to 7 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric and young adult patients (ages 4 to <21 years)
- Known or suspected malignancy other than lymphoma
- Undergoing clinically indicated CT of the chest
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center Burnet Campus
Cincinnati, Ohio, 45229
About this study
Official title: Validation of an Extremely Low Dose Computed Tomography Protocol for Diagnosing Lung Nodules in Children and Young Adults
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.
- Conditions
- Cancer, Metastasis to Lung
- Being tested
- Extremely Low Dose CT
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extremely Low Dose CTDiagnostic test
Patients undergoing a clinically indicated chest CT will also undergo the extremely low dose CT
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Patients will receive both the clinically indicated and extremely low dose exams Receives: Diagnostic Test: Extremely Low Dose CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of extremely low dose CT
Sensitivity
Measured: At time of imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start30 Nov 2018
- Primary completion2 Sep 2020
- Study completion7 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681873
- Sponsor's protocol ID
- 2018-6122
- Status last verified
- Aug 2022
- First submitted
- 18 Sep 2018
- Last updated
- 15 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hardie RC, Trout AT, Dillman JR, Narayanan BN, Tanimoto AA. Performance of Lung Nodule Computer-Aided Detection Systems on Standard-Dose and Low-Dose Pediatric CT Scans: An Intraindividual Comparison. AJR Am J Roentgenol. 2025 Jan;224(1):e2431972. doi: 10.2214/AJR.24.31972. Epub 2024 Oct 9.
PubMed 39382534Thapaliya 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.
PubMed 34232694
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of an Extremely Low Dose Computed Tomography Protocol for Diagnosing Lung Nodules in Children and Young Adults
- ClinicalTrials.gov ID
- NCT03681873
- Acronym / sponsor ID
- 2018-6122
- Conditions
- Cancer, Metastasis to Lung
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 2 Sep 2020 (actual)
- Study completion
- 7 Sep 2021 (actual)
- First posted
- 24 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Diagnostic Test: Extremely Low Dose CTPatients will receive both the clinically indicated and extremely low dose exams |
Who may qualify
- Ages
- 4 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Pediatric and young adult patients (ages 4 to <21 years)
- Known or suspected malignancy other than lymphoma
- Undergoing clinically indicated CT of the chest
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extremely Low Dose CTPatients undergoing a clinically indicated chest CT will also undergo the extremely low dose CT | Diagnostic test | Study Group |
Primary outcome
Diagnostic performance of extremely low dose CT
Time frame: At time of imaging
Sensitivity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
- Derived from this study: PubMed 39382534Hardie RC, Trout AT, Dillman JR, Narayanan BN, Tanimoto AA. Performance of Lung Nodule Computer-Aided Detection Systems on Standard-Dose and Low-Dose Pediatric CT Scans: An Intraindividual Comparison. AJR Am J Roentgenol. 2025 Jan;224(1):e2431972. doi: 10.2214/AJR.24.31972. Epub 2024 Oct 9.
- Derived from this study: PubMed 34232694Thapaliya 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extremely Low Dose CT in people with Cancer and Metastasis to Lung, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of extremely low dose CT (time frame: At time of imaging). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03681873, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2022.