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

Medical University of South Carolina (MUSC)

Status: Terminated

Conditions: PET CT

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03146117

Pro00060975

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.