T-Cell PET Imaging With [18F]F-AraG in Lung Cancer



Status:Recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/9/2019
Start Date:November 26, 2017
End Date:December 1, 2020
Contact:Dora Tao
Email:dora.tao@ucsf.edu
Phone:415-514-6749

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T-Cell PET Imaging With [18F]F-AraG and Radiomics to Guide Combined Radiation and Systemic Immune Modulating Therapies

This is a single-center cross-sectional imaging study in patients with localized lung cancer
undergoing immunotherapy with or without stereotactic radiation therapy as part of the
companion clinical trial (NCT03217071; Pembrolizumab With and Without Radiotherapy for
Non-Small Cell Lung Cancer). Each patient will undergo a single [18F]F-AraG PET exam as part
of this study. [18F]F-AraG will be administered at a single time point intravenously prior to
PET imaging. Whole-body PET will be acquired along with a whole body low dose CT (PET/CT)
used for attenuation correction and anatomic localization of [18F]F-AraG uptake, SUV
calculation, and volumetric selection for radiomic analyses.

This is a single-center cross-sectional imaging study in patients with localized lung cancer
undergoing immunotherapy with or without stereotactic radiation therapy as part of the
companion clinical trial (NCT03217071; Pembrolizumab With and Without Radiotherapy for
Non-Small Cell Lung Cancer). Each patient will undergo a single [18F]F-AraG PET exam as part
of this study. [18F]F-AraG will be administered at a single time point intravenously prior to
PET imaging. Whole-body PET will be acquired along with a whole body low dose CT (PET/CT)
used for attenuation correction and anatomic localization of [18F]F-AraG uptake, SUV
calculation, and volumetric selection for radiomic analyses.

A total of 20 patients will be enrolled over an accrual period of approximately 12 months.
Approximately 10 patients will be enrolled in the immunotherapy alone cohort and
approximately 10 patients will be enrolled in the immunotherapy and stereotactic radiation
therapy cohort.

Patients will be evaluated one day and one week via telephone after each radiopharmaceutical
injection for safety follow-up. All adverse events will be recorded. Due to the noninvasive
and non-therapeutic nature of the study, potential risks of the study are anticipated to be
low.

Inclusion Criteria:

1. Age greater than or equal to 18 years

2. Histologically or cytologically documented stage I-IIIA non-small cell lung cancer
(NSCLC)

3. Eligible for with plan to undergo immunotherapy alone or both immunotherapy and
stereotactic radiation therapy as part of NCT03217071

4. In female patients, negative pregnancy test with no plans to become pregnant during
the duration of the study

5. Able to provide informed consent and follow the study guidelines

Exclusion Criteria:

1. Female patients who are pregnant or breastfeeding
We found this trial at
1
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San Francisco, California 94143
Phone: 415-514-6759
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