NCT02738398

Brief Summary

Prospective study of the effects of image acquisition and reconstruction parameters on accuracy of FDG PET/CT mediastinal nodal staging in NSCLC

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 14, 2016

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2026

Completed
Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

9.8 years

First QC Date

April 12, 2016

Last Update Submit

February 26, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of Adverse Events

    1 year

Study Arms (1)

PET imaging

EXPERIMENTAL

PET imaging

Radiation: FDG PET/CT

Interventions

FDG PET/CTRADIATION
PET imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Daniel Pryma, MD

    Abramson Cancer Center at Penn Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2016

First Posted

April 14, 2016

Study Start

April 1, 2016

Primary Completion

January 27, 2026

Study Completion

January 27, 2026

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations