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

Non-small Cell Lung Cancer Clinical Trial

Official title:

T-Cell PET Imaging With [18F]F-AraG and Radiomics to Guide Combined Radiation and Systemic Immune Modulating Therapies

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03311672
• Other study ID #: 176513
• Secondary ID: NCI-2018-02158
• Status: Withdrawn
• Phase: Phase 2
• Start date: November 26, 2017
• Est. completion date: October 15, 2019

Study information

• Verified date: October 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 15, 2019
• Est. primary completion date: October 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• [18F]F-Ara-G
Administered after two cycles of immunotherapy +/- stereotactic radiation therapy as part of the PET/CT scan.
• Pembrolizumab
All study participants will receive pembrolizumab every 3 weeks, for 2 cycles.

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	CellSight Technologies, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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)	Baseline (after two cycles of pembrolizumab)
Secondary	The detection of out-of-target radiation-mediated immune modulation in lymph nodes using [18F]F-AraG PET	The detection of out-of-target radiation-mediated immune modulation in lymph nodes using [18F]F-AraG PET	Baseline (after two cycles of pembrolizumab)