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

March 16, 2021 updated by: Abramson Cancer Center of the University of Pennsylvania

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10

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

  • United States
    • 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

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult men and women of any ethnicity with NSCLC deemed unresectable by CT or PET imaging criteria and planning to start anti-PD1/PDL1 therapy.

Description

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.
  • Patients who have undergone cancer surgery removing a significant portion of active disease, in the opinion of an investigator, within 2 months prior to study enrollment will be excluded.
  • Patients who have received prior immunotherapy.
  • Patients with an active auto-immune disease (ie. Multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus, vasculitis).
  • Inability to tolerate imaging procedures in the opinion of the investigator or treating physician
  • Serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject's safety or successful participation in the study.
  • Unwilling or unable to provide informed consent

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of inflammatory changes within the tumor
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center of the University of Pennsylvania

Investigators

  • Principal Investigator: Sharyn Katz, MD, Abramson Cancer Center of the University of Pennsylvania

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 (Actual)

October 22, 2015

Primary Completion (Actual)

July 18, 2019

Study Completion (Actual)

July 18, 2019

Study Registration Dates

First Submitted

November 17, 2015

First Submitted That Met QC Criteria

November 17, 2015

First Posted (Estimate)

November 18, 2015

Study Record Updates

Last Update Posted (Actual)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 16, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 15515

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.

Clinical Trials on Non-Small Cell Lung Cancer (NSCLC)

Clinical Trials on [18F]fluoroglucose(FDG)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe