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

This study is not yet open for participant recruitment.
Verified October 2017 by Benjamin Franc, University of California, San Francisco
Sponsor:
ClinicalTrials.gov Identifier:
NCT03311672
First Posted: October 17, 2017
Last Update Posted: October 17, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
CellSight Technologies, Inc.
Information provided by (Responsible Party):
Benjamin Franc, University of California, San Francisco
  Purpose
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 Intervention Phase
Non-small Cell Lung Cancer Drug: [18F]F-Ara-G Drug: Pembrolizumab Radiation: PET/CT scan Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Benjamin Franc, University of California, San Francisco:

Primary Outcome Measures:
  • 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:
  • 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


Estimated Enrollment: 20
Anticipated Study Start Date: November 1, 2017
Estimated Study Completion Date: November 1, 2018
Estimated Primary Completion Date: November 1, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
No Contacts or Locations Provided
  More Information

Responsible Party: Benjamin Franc, Professor of Clinical Radiology, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03311672     History of Changes
Other Study ID Numbers: 17-23431
CC# 176513 ( Other Identifier: University of California, San Francisco )
First Submitted: October 11, 2017
First Posted: October 17, 2017
Last Update Posted: October 17, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Pembrolizumab
Antineoplastic Agents