Back to resultsFDG PET/CT in Lung Cancer Staging
Primary Purpose
Non-Small Cell Lung Cancer (NSCLC)
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FDG PET/CT
Sponsored by
About this trial
This is an interventional treatment trial for Non-Small Cell Lung Cancer (NSCLC)
Eligibility Criteria
Inclusion Criteria:
- Adult patients, at least 18 years of age
- Patients with NSCLC diagnosis who have been referred for a clinical FDG PET/CT staging scan as part of their standard of care
- Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.
Exclusion Criteria:
- Inability to tolerate additional imaging time in the opinion of the investigator or treating physician.
- Only individuals (aged 18 or over) who can understand and give informed consent will be eligible to participate in this study. Individuals who are considered to be mentally disabled will not be recruited for this study. All subjects must be able to give informed consent. We will not be using specific methods to assess decisional capacity. Economically disadvantaged persons will not be vulnerable to undue influence, as this study offers no compensation and there is no additional cost associated with the additional study imaging time. All individuals will be told that their choice regarding study participation will in no way change their access to clinical care or their ability to undergo the standard clinical FDG PET/CT scan. This should negate any undue influence or coercion. Children, fetuses, neonates, or prisoners are not included in this research study
Sites / Locations
- Abramson Cancer Center of the University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PET imaging
Arm Description
PET imaging
Outcomes
Primary Outcome Measures
Number of Adverse Events
Secondary Outcome Measures
Full Information
NCT ID
NCT02738398
First Posted
April 12, 2016
Last Updated
November 11, 2022
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02738398
Brief Title
FDG PET/CT in Lung Cancer Staging
Official Title
Optimizing Lung Cancer Nodal Staging With FDG PET/CT Through Improved Image Acquisition and Reconstruction
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2016 (undefined)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Prospective study of the effects of image acquisition and reconstruction parameters on accuracy of FDG PET/CT mediastinal nodal staging in NSCLC
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer (NSCLC)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PET imaging
Arm Type
Experimental
Arm Description
PET imaging
Intervention Type
Radiation
Intervention Name(s)
FDG PET/CT
Primary Outcome Measure Information:
Title
Number of Adverse Events
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients, at least 18 years of age
Patients with NSCLC diagnosis who have been referred for a clinical FDG PET/CT staging scan as part of their standard of care
Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.
Exclusion Criteria:
Inability to tolerate additional imaging time in the opinion of the investigator or treating physician.
Only individuals (aged 18 or over) who can understand and give informed consent will be eligible to participate in this study. Individuals who are considered to be mentally disabled will not be recruited for this study. All subjects must be able to give informed consent. We will not be using specific methods to assess decisional capacity. Economically disadvantaged persons will not be vulnerable to undue influence, as this study offers no compensation and there is no additional cost associated with the additional study imaging time. All individuals will be told that their choice regarding study participation will in no way change their access to clinical care or their ability to undergo the standard clinical FDG PET/CT scan. This should negate any undue influence or coercion. Children, fetuses, neonates, or prisoners are not included in this research study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Pryma, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
FDG PET/CT in Lung Cancer Staging
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