PET-DECT for Staging and Imaged Based Radiotherapy Planning in Lung Cancer

Sponsor

Medical University of South Carolina (Other)

Overall Status

Terminated

CT.gov ID

NCT03146117

Collaborator

Siemens Corporation, Corporate Technology (Industry)

Enrollment

Location

14.5

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The overall goal of this project is to investigate the diagnostic performance of integrated F-18 fluorodeoxyglucose-positron emission tomography (FDG-PET) and Dual Energy CT (DECT) imaging in determining the thoracic nodal status of small-cell lung cancer (SCLC) and non-small-cell lung cancer (NSCLC), and its impact on target volume delineation for image guided radiation therapy (IGRT) planning.

Condition or Disease	Intervention/Treatment	Phase
PET CT

Study Design

Study Type:

Observational

Actual Enrollment :

25 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Application of Integrated PET and Dual Energy CT Imaging for Staging and Imaged Based Radiotherapy Treatment Planning in Lung Cancer

Actual Study Start Date :

Apr 1, 2017

Actual Primary Completion Date :

Jun 15, 2018

Actual Study Completion Date :

Jun 15, 2018

Outcome Measures

Primary Outcome Measures

PET-CT accuracy for lung tumor and thoracic adenopathy detection [One year]
Knowledge gained during this study may potentially allow for an improvement in PET-CT accuracy for lung tumor and thoracic adenopathy detection, and for a more accurate definition of the RT target, decreasing the radiation dose delivered to normal tissue.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

To be eligible for the study: (All answers must be "YES" for subject to be eligible.)

Subject must have a suspected SCLC or NSCLC.
Subject must be 18-90 years of age.
Subject must have been referred for a clinically indicated PET-CT.
Subject must provide written informed consent prior to any study-related procedures being performed.
Subject must be willing to comply with all clinical study procedures.

Exclusion Criteria:

The presence of the following excludes subjects from the study: (All answers must be "NO" for subject to be eligible.)

Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:

By testing (serum or urine βHCG) within 24 hours before contrast agent administration, or
By surgical sterilization, or
Post-menopausal, with minimum one (1) year history without menses.

Subject has impaired renal function (eGFR<30 mL/min).
Subject has an acute psychiatric disorder or is cognitively impaired.
Subject is using or is dependent on substances of abuse.
Subject is unwilling to comply with the requirements of the protocol.
Subject has an allergy against iodinated contrast agents and cannot be premedicated.
Subject is in acute unstable condition.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29401

Sponsors and Collaborators

Medical University of South Carolina
Siemens Corporation, Corporate Technology

Investigators

Principal Investigator: Carlo De Cecco, MD PHD, Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medical University of South Carolina

ClinicalTrials.gov Identifier:

NCT03146117

Other Study ID Numbers:

Pro00060975

First Posted:

May 9, 2017

Last Update Posted:

Jun 21, 2018

Last Verified:

Jun 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Medical University of South Carolina

PET CT

Study Results

No Results Posted as of Jun 21, 2018