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18F-FSPG PET/CT Imaging for Lung Cancer

Phase 2
Recruiting
Led By Carina M Aparici
Research Sponsored by Andrei Iagaru
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current or former cigarette smoker, with >= 20 pack years
Be older than 18 years old
Must not have
History or previous diagnosis of lung cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is testing a new imaging agent, 18F-FSPG, to see if it can help diagnose early lung cancer in patients with lung nodules.

Who is the study for?
This trial is for current or former cigarette smokers who have smoked at least the equivalent of a pack a day for 20 years. They must have lung nodules sized between 7 to 30 mm and are already scheduled for standard PET imaging. Pregnant or nursing individuals, those with past lung cancer, or any cancer diagnosis in the last five years cannot participate.Check my eligibility
What is being tested?
The study is testing if using an imaging agent called 18F-FSPG before a PET/CT scan can better diagnose early lung cancer in patients with lung nodules compared to the standard method that uses an agent known as 18F-FDG.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include reactions to the imaging agents such as mild rash, itching, or discomfort at injection site. The PET/CT procedure itself is generally safe but carries minimal risks associated with radiation exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have smoked at least 20 pack-years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with lung cancer before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) specificity for malignant lung nodules
Secondary outcome measures
Improved performance of prediction model for lung nodules

Side effects data

From 2022 Phase 2 trial • 46 Patients • NCT02448225
9%
Dyspnea
9%
Non-cardiac chest pain
2%
Pneumothorax
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT)Experimental Treatment4 Interventions
Patients receive 18F-FSPG IV and, undergo a PET/CT scan over 30-60 minutes. Within 24 hours-14 days, patients receive 18F-FDG IV and undergo a second PET/CT scan over 30-60 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
2008
Completed Phase 2
~2210
Computed Tomography
2017
Completed Phase 2
~2720
Fludeoxyglucose F-18
2018
Completed Phase 4
~590
Fluorine F 18 L-glutamate Derivative BAY94-9392
2015
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Boston UniversityOTHER
461 Previous Clinical Trials
9,951,645 Total Patients Enrolled
Andrei IagaruLead Sponsor
15 Previous Clinical Trials
546 Total Patients Enrolled
Canary FoundationOTHER
4 Previous Clinical Trials
4,604 Total Patients Enrolled

Media Library

Fluorine F 18 L-glutamate Derivative BAY94-9392 Clinical Trial Eligibility Overview. Trial Name: NCT03824535 — Phase 2
Pulmonary Nodules Research Study Groups: Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT)
Pulmonary Nodules Clinical Trial 2023: Fluorine F 18 L-glutamate Derivative BAY94-9392 Highlights & Side Effects. Trial Name: NCT03824535 — Phase 2
Fluorine F 18 L-glutamate Derivative BAY94-9392 2023 Treatment Timeline for Medical Study. Trial Name: NCT03824535 — Phase 2
~3 spots leftby Dec 2024
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