Clinical trial NCT03311672: T-Cell PET Imaging With [18F]F-AraG in Lung Cancer
Official title: T-Cell PET Imaging With [18F]F-AraG and Radiomics to Guide Combined Radiation and Systemic Immune Modulating Therapies
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: CellSight Technologies, Inc.
First posted: 2017-10-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The correlation between number of infiltrating CD3+ T cells/μm2 in the non-small cell lunger cancer thoracotomy specimen as quantified by immunohistochemistry and the activated T-cell concentration as determined by [18F]F-AraG PET (SUVmax)
timeFrame: Baseline (after two cycles of pembrolizumab)
Secondary outcomes:
measure: The detection of out-of-target radiation-mediated immune modulation in lymph nodes using [18F]F-AraG PET
timeFrame: Baseline (after two cycles of pembrolizumab)
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Francisco
name: Sue Yom, MD
role: PRINCIPAL_INVESTIGATOR
References: