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

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ClinicalTrials.gov Identifier: NCT03311672
Recruitment Status : Recruiting
First Posted : October 17, 2017
Last Update Posted : May 1, 2018
Sponsor:
Collaborator:
CellSight Technologies, Inc.
Information provided by (Responsible Party):
Benjamin Franc, University of California, San Francisco

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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
Estimated Primary Completion Date : November 1, 2018
Estimated Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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.




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



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


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


Contacts
Contact: Dora Tao 415-514-6749 dora.tao@ucsf.edu

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94107
Contact: Dora Tao    415-514-6759    dora.tao@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
CellSight Technologies, Inc.

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 Posted: October 17, 2017    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

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