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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03146117

Enrollment

Registered

2017-05-09

Start date

2017-04-01

Completion date

2018-06-15

Last updated

2018-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PET CT

Keywords

PET CT

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results