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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03311672
Recruitment Status : Withdrawn (Low Accrual)
First Posted : October 17, 2017
Last Update Posted : October 21, 2019
Sponsor:
Collaborator:
CellSight Technologies, Inc.
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Drug: [18F]F-Ara-G Drug: Pembrolizumab Radiation: PET/CT scan Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: T-Cell PET Imaging With [18F]F-AraG and Radiomics to Guide Combined Radiation and Systemic Immune Modulating Therapies
Actual Study Start Date : November 26, 2017
Actual Primary Completion Date : October 15, 2019
Actual Study Completion Date : October 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1 - Immunotherapy Alone
Approximately 10 patients will be enrolled in the immunotherapy alone cohort under a larger two-year industry-funded, investigator-initiated single-institution, phase II, open-label clinical trial (NCT03217071; Pembrolizumab With and Without Radiotherapy for Non-Small Cell Lung Cancer) in which patients with stage I-IIIA non-small cell lung cancer (NSCLC) are randomized to receive two cycles of systemic immunotherapy (pembrolizumab, a PD-1 inhibitor) with or without immune-priming stereotactic radiation therapy (SRT, 12 Gy) to the lateral half of the primary lung tumor prior to resection.
 Drug: [18F]F-Ara-G
Administered after two cycles of immunotherapy +/- stereotactic radiation therapy as part of the PET/CT scan.
Other Name: 2'-deoxy-2'-[18F]fluoro-9-β-Darabinofuranosylguanine

Drug: Pembrolizumab
All study participants will receive pembrolizumab every 3 weeks, for 2 cycles.
Other Name: Keytruda

Radiation: PET/CT scan
Scan will be done after two cycles of immunotherapy +/- stereotactic radiation therapy.
Experimental: Cohort 2 - Immunotherapy with Stereotactic Radiation
Approximately 10 patients will be enrolled in the immunotherapy with stereotactic radiation therapy cohort under a larger two-year industry-funded, investigator-initiated single-institution, phase II, open-label clinical trial (NCT03217071; Pembrolizumab With and Without Radiotherapy for Non-Small Cell Lung Cancer) in which patients with stage I-IIIA non-small cell lung cancer (NSCLC) are randomized to receive two cycles of systemic immunotherapy (pembrolizumab, a PD-1 inhibitor) with or without immune-priming stereotactic radiation therapy (SRT, 12 Gy) to the lateral half of the primary lung tumor prior to resection.
 Drug: [18F]F-Ara-G
Administered after two cycles of immunotherapy +/- stereotactic radiation therapy as part of the PET/CT scan.
Other Name: 2'-deoxy-2'-[18F]fluoro-9-β-Darabinofuranosylguanine

Drug: Pembrolizumab
All study participants will receive pembrolizumab every 3 weeks, for 2 cycles.
Other Name: Keytruda

Radiation: PET/CT scan
Scan will be done after two cycles of immunotherapy +/- stereotactic radiation therapy.


Outcome Measures
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Primary Outcome Measures :
  1. 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) [ Time Frame: Baseline (after two cycles of pembrolizumab) ]
    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)


Secondary Outcome Measures :
  1. The detection of out-of-target radiation-mediated immune modulation in lymph nodes using [18F]F-AraG PET [ Time Frame: Baseline (after two cycles of pembrolizumab) ]
    The detection of out-of-target radiation-mediated immune modulation in lymph nodes using [18F]F-AraG PET


Eligibility Criteria
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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:

  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

Contacts and Locations
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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): NCT03311672


Sponsors and Collaborators
University of California, San Francisco
CellSight Technologies, Inc.
Investigators
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Principal Investigator: Sue Yom, MD University of California, San Francisco
More Information
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03311672    
Other Study ID Numbers: 176513
NCI-2018-02158 ( Other Identifier: NCI Clinical Trials Reporting Program (CTRP) )
First Posted: October 17, 2017    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
 Lung Diseases
Respiratory Tract Diseases
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents