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[18F]F-AraG PET Imaging for Lung Cancer

Phase < 1

Waitlist Available

Led By Simor R Cherry, PhD

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 1 tumor lesion > 1 cm (cannot be only in liver) documented on CT or MRI or FDG-PET/CT (RECIST criteria 1.1; >1.5 cm for nodal lesions) within 45 days prior to scan date

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 7-14 days after first dose of pd-1/pd-l1

Awards & highlights

Study Summary

This trial will study the effects of a new cancer treatment drug by imaging the volunteers and patients before and after taking the drug.

Who is the study for?

This trial is for adults with advanced Non-Small Cell Lung Cancer (NSCLC) who have a tumor larger than 1 cm, not solely in the liver. They must be planning to undergo PD-1 or PD-L1 inhibitor therapy and have an ECOG performance status of ≤2. Healthy volunteers can also join if they weigh less than 240 kg and are willing to use effective contraception during the study.Check my eligibility

What is being tested?

[18F]F-AraG imaging is being tested using a total body PET/CT scanner on both healthy individuals and NSCLC patients. The goal is to gather preliminary data about how the body processes this substance and how it distributes early on after administration.See study design

What are the potential side effects?

As [18F]F-AraG imaging involves exposure to radiation from PET/CT scanning, potential side effects may include temporary discomfort at injection site, allergic reactions, or increased risk of cancer over time due to radiation exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a tumor larger than 1 cm not only in my liver, confirmed by a scan within the last 45 days.

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I can take care of myself and am up and about more than half of my waking hours.

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My lung cancer is confirmed and at an advanced stage.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Data on whole-body pharmacokinetics of [18F]F-AraG pathologic uptake in tumor lesions relative to uptake in background tissues in NSCLC subjects

Body tissue

Develop recommendations for ideal time post [18F]F-AraG infusion to acquire static whole-body scans using standard PET scanners

Secondary outcome measures

Non-Small Cell Lung Carcinoma

Trial Design

2Treatment groups

Experimental Treatment

Group I: Non-Small Cell Lung Cancer Patients (NSCLC)Experimental Treatment1 Intervention

Study participants with NSCLC who are planned to receive PD-1/PD-L1 immunotherapy will undergo a pre-therapy dynamic [18F]F-AraG PET/CT scan, and an optional post-therapy (first dose only) dynamic [18F]F-AraG PET/CT scan on the uEXPLORER total-body scanner.

Group II: Healthy VolunteersExperimental Treatment1 Intervention

Study participants will undergo a single dynamic [18F]F-AraG PET/CT scan (of duration up to 90-minutes) on the uEXPLORER PET/CT scanner. There will be a follow-up visit or call 7 days after the scan to assess any adverse events that could be attributed to either the scan or the administration of [18F]F-AraG.

0 / 4Eligibility criteria met

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Who is running the clinical trial?

CellSight Technologies, Inc.Industry Sponsor

17 Previous Clinical Trials

303 Total Patients Enrolled

University of California, DavisLead Sponsor

911 Previous Clinical Trials

4,709,575 Total Patients Enrolled

Simor R Cherry, PhDPrincipal InvestigatorUC Davis

Media Library

[18F]F-AraG Imaging Clinical Trial Eligibility Overview. Trial Name: NCT04678440 — Phase < 1

Non-Small Cell Lung Cancer Research Study Groups: Healthy Volunteers, Non-Small Cell Lung Cancer Patients (NSCLC)

Non-Small Cell Lung Cancer Clinical Trial 2023: [18F]F-AraG Imaging Highlights & Side Effects. Trial Name: NCT04678440 — Phase < 1

[18F]F-AraG Imaging 2023 Treatment Timeline for Medical Study. Trial Name: NCT04678440 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the current recruitment phase of this research still underway?

"As detailed in the clinicaltrials.gov records, recruitment for this trial has ceased; it was initially posted on March 31st 2021 and most recently updated on August 1st 2022. Nonetheless, there are 2048 other active studies that can be applied to by prospective participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

[18F]F-AraG/Total Body PET Imaging and Healthy Subjects and Lung Cancer Patients

Simon R. Cherry 2021. "[18F]F-AraG/Total Body PET Imaging and Healthy Subjects and Lung Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04678440.