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

Terminated

• Conditions: PET CT

• Registration Number: NCT03146117
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2017-05-05
• Study First Submitted QC: 2017-05-05
• Study First Posted: 2017-05-09
• Status Verified: 2018-06
• Primary Completion: 2018-06-15
• Study Completion: 2018-06-15
• Last Update Submitted: 2018-06-19
• Last Update Posted: 2018-06-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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.

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States