Simultaneous Coronary Artery Evaluation and Lung Cancer CT Screening

NCT03727958 | Unknown DMC

• 1 other identifier: 2018/D/789
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cardiac computed tomography (CT) is often performed in patients who are at high risk for lung cancer in whom screening is currently recommended. This pilot randomized study will test the feasibility, safety and diagnostic ability of a novel ultra-low-dose CT protocol that allows concomitant coronary artery evaluation and lung screening. Current or former heavy smoker subjects with suspected or known coronary artery disease will be randomized to undergo CT assessment of either thoracic area only or both coronary arteries and thoracic area. Primary end-points will be the effective contrast and radiation doses.

Conditions

HEAVY SMOKING

Outcome Measures

Primary Outcomes (1)

• Safety of computed tomography as measured by effective radiation dose (as measured in mSv)

  Measurement of the effective radiation dose (as measured in mSv) at time of computed tomography

  Through study completion, an average of 2 months

Study Arms (2)

Lung and coronary CT assessment

ACTIVE COMPARATOR

Subjects will undergo simultaneous CT assessment of both coronary arteries and thoracic area

Diagnostic Test: Lung and coronary CT assessment

Coronary CT assessment

ACTIVE COMPARATOR

Subjects will undergo CT assessment of coronary arteries only

Diagnostic Test: Coronary CT assessment

Interventions

Lung and coronary CT assessment DIAGNOSTIC_TEST

Subjects will undergo simultaneous coronary arteries and thoracic CT assessment

Lung and coronary CT assessment

Coronary CT assessment DIAGNOSTIC_TEST

Subjects will undergo coronary arteries CT assessment only

Coronary CT assessment

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic subjects with effort-induced or typical chest pain
• High probability of coronary artery disease
• Known coronary artery disease
• Willing to participate to the study
• Informed consent to undergo CT scan

You may not qualify if:

• Contraindications to iodinated contrast such as allergies and chronic kidney failure
• Any suspicion of pregnancy

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Related Publications (1)

• Gaudio C, Tanzilli A, Mei M, Moretti A, Barilla F, Varveri A, Paravati V, Tanzilli G, Ciccaglioni A, Strano S, Pellegrini M, Barillari P, Pelliccia F. Concomitant screening of coronary artery disease and lung cancer with a new ultrafast-low-dose Computed Tomography protocol: A pilot randomised trial. Sci Rep. 2019 Sep 25;9(1):13872. doi: 10.1038/s41598-019-50407-6.

  PMID: 31554878 DERIVED

Study Officials

• Francesco Pelliccia, MD

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Pelliccia, MD

CONTACT

+390633062615; f.pelliccia@mclink.it

Francesco Gaudio, MD

CONTACT

+390633062615; f.pelliccia@mclink.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Current or former heavy smoker subjects with suspected or known coronary artery disease will be randomized to undergo CT assessment of both coronary arteries and thoracic area for simultaneous coronary artery and lung cancer screening

Study Record Dates

• First Submitted: October 28, 2018
• First Posted: November 1, 2018
• Study Start: November 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: November 1, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share