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

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ClinicalTrials.gov Identifier: NCT02608528
Recruitment Status : Recruiting
First Posted : November 18, 2015
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

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.


Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer (NSCLC) Radiation: [18F]fluoroglucose(FDG) Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Primary Purpose: Basic Science
Official Title: Serial [18F]Fluorodeoxyglucose ([18F]FDG )PET/CT as a Biomarker of Therapeutic Response in Anti-PD1/PDL1 Therapy
Study Start Date : September 2015
Estimated Primary Completion Date : September 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Number of inflammatory changes within the tumor [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608528


Contacts
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Contact: Sharyn Katz, MD 855-216-0098 PennCancerTrials@emergingmed.com

Locations
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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Sharyn Katz, MD    855-216-0098    PennCancerTrials@emergingmed.com   
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
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Principal Investigator: Sharyn Katz, MD Abramson Cancer Center of the University of Pennsylvania

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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02608528    
Other Study ID Numbers: UPCC 15515
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action