Imaging of T-cell Activation With [18F]F-AraG in Advanced... | NCT04726215

Studies
Imaging of T-cell Activation With [18F]F-AraG in Advanced Non Small Cell Lung Cancer

NCT04726215

Sponsor

CellSight Technologies, Inc.

Status

Unknown status

Last Update Posted

Sep 29, 2023Actual

Enrollment

50Estimated

Phase

Phase 2

Conditions

Non Small Cell Lung Cancer

Interventions

[18F]F AraG

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Apr 15, 2021Actual

Primary Completion Date

Oct 15, 2024Estimated

Completion Date

Oct 15, 2024Estimated

First Submitted Date

Jan 21, 2021

First Submission Date that Met QC Criteria

Jan 22, 2021

First Posted Date

Jan 27, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2023

Last Update Posted Date

Sep 29, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a pilot study using [18F]F AraG PET imaging to evaluate the immunological response to checkpoint inhibitor therapy (CkIT) in patients with advanced NSCLC tumors at multiple study sites. The main objectives of the study are to quantify the change in [18F]F AraG PET signal before and after CkIT therapy, and to correlate this change in [18F]F AraG PET signal with a radiographic response.

Detailed Description

Approximately 50 patients will undergo two research PET/CT scans with [18F]F AraG at two time points. Each patient will receive two 5 (+/-10%) mCi doses of [18F]F AraG, one for each imaging time point. Eligible subjects will undergo a pre-treatment [18F]F AraG PET/CT scan within 7 days prior to treatment, followed by treatment, and an on-treatment [18F]F AraG PET/CT within 7-14 days of treatment.

Objectives:

Quantify [18F]F-AraG uptake in advanced NSCLC tumor (primary, nodal, and metastatic sites) at baseline and after 1 dose of anti-PD-1/PD-L1 therapy in patients treated with standard of care immunotherapy (as monotherapy or part of combination therapy).
Correlate change in [18F]F AraG uptake in tumor lesions with radiographic response.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Name	Type	Description	Arm Group Labels	Other Names
[18F]F AraG	Drug	PET imaging agent specific to activated T cells

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
[18F]F-AraG uptake signal	[18F]F-AraG uptake signal will be measured quantitatively by SUV-bw of the tumor volumes of interest before and after undergoing treatment	two years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with a histologically confirmed NSCLC and planned to undergo immunotherapy as monotherapy or as combination therapy with concurrent as treatment for advanced/metastatic disease.
RECIST measurable disease.
ECOG performance status of 0, 1 or 2.
Life expectancy >/= 6 months at enrollment.

Exclusion Criteria:

Serious comorbidities that in the opinion of the investigator/sponsor could compromise protocol objectives.
Pregnant women or nursing mothers.
Patients with severe claustrophobia.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
SAMUEL QUEZADA	Contact	6507991589		squezada@cellsighttech.com

Overall Officials

Name	Affiliation	Role
Deepak Behera, MD	CellSight Technologies, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Palo Alto Veterans Institute of Research	Recruiting	Palo Alto	California	94304	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39448270	Derived	Levi J, Das M, Vasanawala MS, Behl D, Pomper M, Forde PM, Nakajima E, Sayre J, Shen B, Cabrera H, Del Mar N, Gullen M, Pierini M, Cox L, Lokre O, Perk T, Chae HD. [18F]F-AraG Uptake in Vertebral Bone Marrow May Predict Survival in Patients with Non-Small Cell Lung Cancer Treated with Anti-PD-(L)1 Immunotherapy. J Nucl Med. 2024 Dec 3;65(12):1869-1875. doi: 10.2967/jnumed.124.268253.

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms