- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02738398
FDG PET/CT in Lung Cancer Staging
January 18, 2024 updated by: Abramson Cancer Center at Penn Medicine
Optimizing Lung Cancer Nodal Staging With FDG PET/CT Through Improved Image Acquisition and Reconstruction
Prospective study of the effects of image acquisition and reconstruction parameters on accuracy of FDG PET/CT mediastinal nodal staging in NSCLC
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Abramson Cancer Center of the University of Pennsylvania
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PET imaging
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Adverse Events
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Daniel Pryma, MD, Abramson Cancer Center at Penn Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2016
Primary Completion (Estimated)
October 1, 2024
Study Completion (Estimated)
October 1, 2024
Study Registration Dates
First Submitted
April 12, 2016
First Submitted That Met QC Criteria
April 12, 2016
First Posted (Estimated)
April 14, 2016
Study Record Updates
Last Update Posted (Actual)
January 19, 2024
Last Update Submitted That Met QC Criteria
January 18, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UPCC 20515
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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