Test-retest Evaluation of [18F]F-AraG PET

ConditionNon-small Cell Lung Cancer

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorCellSight Technologies, Inc.

About this trial

This pilot study aims to evaluate the test-retest variability of \[18F\]F-AraG-PET imaging in patients with advanced NSCLC tumors. The main objectives of the study are to quantify the uptake of \[18F\]F-AraG in tumors and lymphoid tissue in two consecutive scans spaced not longer than 7 days apart from each other to estimate the magnitude of physiologic and measurement variability. To explore these objectives, eligible subjects will undergo two \[18F\]F-AraG PET/CT scans within 7 days of each other prior to receiving treatment. This study is a single-site, open-label, non-randomized, single-arm pilot trial. Patients and care providers will not be blinded to any part of the study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients (>18 years old) with a histologically confirmed NSCLC and a candidate to receive immunotherapy as monotherapy or as combination therapy for advanced/metastatic disease.

Measurable disease.

ECOG performance status of 0, 1 or 2.

Disqualifiers

Serious comorbidities that in the opinion of the investigator/sponsor could compromise protocol objectives.

Pregnant women or nursing mothers.

Patients with severe claustrophobia.

Trial design

Design model

Single group

Treatments tested in this trial

[18F]F-ARAG PET
Drug
Two imaging sessions

Treatment groups

10 Participants

are divided into 1 treatment group

Group A: Advanced non small cell lung cancer (NSCLC) patientsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

[18F]F-AraG Test - Re Test

• Quantitative assessment of tracer uptake by Standardized Uptake Value (SUV) based measurements within volumes of interest on two consecutive \[18F\]F AraG PET scans

Time frame

7 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CellSight Technologies, Inc.

Lead sponsor

University of Iowa

Collaborator

Source ClinicalTrials.gov

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