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



Status:Recruiting
Conditions:Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/10/2018
Start Date:September 2015
Contact:Sharyn Katz, MD
Email:PennCancerTrials@emergingmed.com
Phone:855-216-0098

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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.


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
We found this trial at
1
site
3400 Civic Center Blvd
Philadelphia, Pennsylvania 19104
(215) 662-6065
Phone: 855-216-0098
Abramson Cancer Center of the University of Pennsylvania The Abramson Cancer Center of the University...
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Philadelphia, PA
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