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

PET CT Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03146117
• Other study ID #: Pro00060975
• Status: Terminated
• Start date: April 1, 2017
• Est. completion date: June 15, 2018

Study information

• Verified date: June 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: June 15, 2018
• Est. primary completion date: June 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ßHCG) 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.

Related Conditions & MeSH terms

• PET CT

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	Siemens Corporation, Corporate Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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