Serial [18F]Fluorodeoxyglucose ([18F]FDG )PET/CT as a Biomarker of Therapeutic Response in Anti-PD1/PDL1 Therapy

Abramson Cancer Center at Penn Medicine1 site in 1 country10 target enrollmentOctober 22, 2015

ConditionsNon-Small Cell Lung Cancer (NSCLC)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Non-Small Cell Lung Cancer (NSCLC)
Sponsor: Abramson Cancer Center at Penn Medicine
Enrollment: 10
Locations: 1
Primary Endpoint: Number of inflammatory changes within the tumor
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Evaluation of FDG PET/CT to image immunotherapy response in adult thoracic cancer.

Compare pre- and post-treatment primary tumor uptake for FDG-PET/CT and correlate with clinical markers of response. PET/CT tumor metabolic response will also be correlated will to progression-free survival and overall survival.

Registry

clinicaltrials.gov

Start Date

October 22, 2015

End Date

July 18, 2019

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Abramson Cancer Center at Penn Medicine

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult patients, at least 18 years of age
•Histologically confirmed non-small cell lung cancer or malignancy pleural mesothelioma with at least one site of disease \> 1 cm by at least one type of standard imaging (e.g.
•CT, chest x-ray, MRI)
•Recommended to start anti-PD1/PDL1 therapy.
•Obtaining pre-PD1/PDL1 therapy clinical re-staging \[18F\]FDG-PET/CT scan at the Hospital of the University of Pennsylvania.
•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.
•Participants must be willing and able to comply with scheduled visits and imaging procedures in the opinion of the investigator or treating physician.
•Exclusion Criteria
•Females who are pregnant or breast-feeding at the time of screening will not be eligible for this study. Female participants of child-bearing potential will have a urine pregnancy test at the time of the screening visit.
•Patients with only a single site of primary non-small cell lung cancer or malignancy pleural mesothelioma who have undergone or are recommended to undergo radiation therapy to that site will not be eligible, the inclusion of patients who may be undergoing radiation therapy to ancillary disease sites may be allowed to enter the study at the discretion of the PI if it is not felt to affect the ability to capture \[18F\]FDG information for at least one primary site of disease.