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

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

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.

Study Overview

• Status: Terminated
• Conditions: PET CT

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29401
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The investigators plan to recruit a total of 50 individuals (male, female; age range 18-90 years) referred to undergo a clinically indicated PET-CT examination. Patients will be identified from the Radiology department schedule. With the proposed 50 patient data set, the investigators are neither targeting nor avoiding the selective recruitment of women and minorities. Given the narrow inclusion criteria, the investigators plan to recruit patients irrespective of demographics. The patient will be approached by IRB-approved study personnel under the direction of one of the licensed physician investigators listed on the study, either prior to or on the day of the planned PET-CT examination (a single study visit, with the objective to perform the clinically indicated imaging), with a full explanation and request for consent as required by the IRB. MUSC policies regarding patient consent will be followed. The study design is not randomized.

Description

Inclusion Criteria:

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

1. Subject must have a suspected SCLC or NSCLC.
2. Subject must be 18-90 years of age.
3. Subject must have been referred for a clinically indicated PET-CT.
4. Subject must provide written informed consent prior to any study-related procedures being performed.
5. 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.)

1. 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.
2. Subject has impaired renal function (eGFR<30 mL/min).
3. Subject has an acute psychiatric disorder or is cognitively impaired.
4. Subject is using or is dependent on substances of abuse.
5. Subject is unwilling to comply with the requirements of the protocol.
6. Subject has an allergy against iodinated contrast agents and cannot be premedicated.
7. Subject is in acute unstable condition.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PET-CT accuracy for lung tumor and thoracic adenopathy detection	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.	One year

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: Siemens Corporation, Corporate Technology
• Investigators: Principal Investigator: Carlo De Cecco, MD PHD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): June 15, 2018
• Study Completion (Actual): June 15, 2018

Study Registration Dates

• First Submitted: May 5, 2017
• First Submitted That Met QC Criteria: May 5, 2017
• First Posted (Actual): May 9, 2017

Study Record Updates

• Last Update Posted (Actual): June 21, 2018
• Last Update Submitted That Met QC Criteria: June 19, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: PET CT
• Other Study ID Numbers: Pro00060975

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No