Clinical Trial: NCT03311672 - My Cancer Genome

NCT03311672

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.

Related Conditions:

Non-Small Cell Lung Carcinoma

Recruiting Status:

Withdrawn

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT03311672

Trial Eligibility

Document

Title

Brief Title: 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

Clinical Trial IDs

ORG STUDY ID: 176513
SECONDARY ID: NCI-2018-02158
NCT ID: NCT03311672

Conditions

Non-small Cell Lung Cancer

Interventions

Drug	Synonyms	Arms
[18F]F-Ara-G	2'-deoxy-2'-[18F]fluoro-9-β-Darabinofuranosylguanine	Cohort 1 - Immunotherapy Alone
Pembrolizumab	Keytruda	Cohort 1 - Immunotherapy Alone

Purpose

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.

Trial Arms

Name	Type	Description	Interventions
Cohort 1 - Immunotherapy Alone	Experimental	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.	[18F]F-Ara-G Pembrolizumab
Cohort 2 - Immunotherapy with Stereotactic Radiation	Experimental	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.	[18F]F-Ara-G Pembrolizumab

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

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

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)
Time Frame:	Baseline (after two cycles of pembrolizumab)
Safety Issue:
Description:	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

Measure:	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)
Safety Issue:
Description:	The detection of out-of-target radiation-mediated immune modulation in lymph nodes using [18F]F-AraG PET

Details

Phase:	Phase 2
Primary Purpose:	Interventional
Overall Status:	Withdrawn
Lead Sponsor:	University of California, San Francisco

Last Updated

October 21, 2019

Clinical Trials /

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