18F-FSPG PET/CT Imaging for Lung Cancer

Overseen By Mahima Goel

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Andrei Iagaru

Disqualifiers: Lung cancer, Recent cancer, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for diagnosing early lung cancer using a PET/CT scan with a special imaging agent called 18F-FSPG (Fluorine F 18 L-glutamate Derivative BAY94-9392). Researchers aim to determine if this method is more effective than standard PET/CT scans in detecting lung cancer in individuals with uncertain lung nodules (small, hard-to-identify lumps in the lung). Participants will undergo two PET/CT scans: one with 18F-FSPG and another with the standard 18F-FDG. Those with a lung nodule between 7 to 30 mm who are current or former heavy smokers may be suitable for this trial. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this imaging technique is safe for diagnosing lung cancer?

Research has shown that the 18F-FSPG tracer used in PET/CT scans has been tested for various cancers, including lung cancer. These studies suggest that patients generally tolerate it well, with no major safety issues reported.

The 18F-FDG tracer has already received FDA approval for diagnosing different cancers. Its safety is well-documented, and it is commonly used in PET scans. Most side effects are mild and temporary.

Previous research has demonstrated the safety of both tracers, 18F-FSPG and 18F-FDG. They help doctors see and analyze cancerous areas more clearly in diagnostic imaging. Participants in studies have generally tolerated these tracers well, with minimal side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a unique method for diagnosing lung cancer using 18F-FSPG PET/CT imaging. Unlike traditional imaging techniques that often rely on Fludeoxyglucose F-18 (18F-FDG), this approach utilizes a new active ingredient, Fluorine F 18 L-glutamate Derivative BAY94-9392, which targets different metabolic pathways in tumors. This could potentially provide clearer and more specific images of cancerous tissues. By improving the accuracy of lung cancer imaging, this trial aims to enhance early detection and treatment planning, offering a promising advancement over current diagnostic methods.

What evidence suggests that 18F-FSPG PET/CT is effective for diagnosing early lung cancer?

This trial will compare the effectiveness of two imaging methods for diagnosing lung cancer. Research has shown that the 18F-FSPG PET/CT scan, which participants will undergo, might diagnose early lung cancer more effectively. Studies have found that 18F-FSPG accumulates in cancerous tissue, making it easier to identify cancerous nodules. In some cases, it can accurately distinguish between non-cancerous and cancerous nodules. Participants will also undergo the 18F-FDG PET/CT scan, already known for its high accuracy in detecting lung cancer, with success rates over 98%. Both imaging methods hold promise for accurately diagnosing lung cancer, potentially leading to earlier detection and better treatment outcomes. ^{6 7 8 9 10}

Who Is on the Research Team?

Carina Mari Aparici

Principal Investigator

Stanford Cancer Institute Palo Alto

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have smoked at least 20 pack-years.

I have a lung nodule between 7 to 30 mm, or multiple with one dominant in this size range.

I am scheduled for a PET scan to check a lung nodule.

Exclusion Criteria

Pregnant or nursing

I have been diagnosed with lung cancer before.

I was diagnosed with cancer within the last 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Imaging

Participants receive 18F-FSPG IV and undergo a PET/CT scan, followed by 18F-FDG IV and a second PET/CT scan within 24 hours to 14 days

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after diagnostic imaging

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Computed Tomography
• Fludeoxyglucose F-18
• Fluorine F 18 L-glutamate Derivative BAY94-9392
• Positron Emission Tomography

Trial Overview 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.

How Is the Trial Designed?

Group I: Diagnostic (18F-FSPG PET/CT, 18F-FDG PET/CT) Experimental Treatment 4 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.

Who Is Running the Clinical Trial?

Andrei Iagaru

Lead Sponsor

Trials

16

Recruited

600+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Boston University

Collaborator

Trials

494

Recruited

9,998,000+

Canary Foundation

Collaborator

Trials

5

Recruited

4,700+

Published Research Related to This Trial

The new tracer (18)F-FSPG demonstrated a high tumor detection rate in patients with hepatocellular carcinoma (HCC), successfully identifying tumors in all 5 patients studied, compared to only 3 out of 5 with the standard (18)F-FDG tracer.

(18)F-FSPG PET imaging was well tolerated by patients and showed strong tumor uptake with lower background noise from normal tissue, suggesting it may be a more effective option for visualizing HCC compared to (18)F-FDG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

(4S)-4-(3-18F-fluoropropyl)-L-glutamate for imaging of xC transporter activity in hepatocellular carcinoma using PET: preclinical and exploratory clinical studies. Baek, S., Mueller, A., Lim, YS., et al.[2017]

The radiosynthesis of the PET biomarker [18F]FSPG achieved a high radiochemical purity of over 95% and a molar activity of 66 GBq/µmol, making it a reliable tool for assessing intracellular redox status in vivo.

Stability tests confirmed that [18F]FSPG remains safe for injection into mice up to 3 hours post-production, with no observable radiolysis, indicating its potential for effective use in PET studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiosynthesis and Analysis of (S)-4-(3-[18F]Fluoropropyl)-L-Glutamic Acid. Brown, G., Soloviev, D., Lewis, DY.[2023]

The novel radiopharmaceutical 18F-FSPG shows excellent tumor visualization in both small animal models and human subjects with brain tumors, achieving a high tumor-to-brain ratio of 32.7, significantly better than other tracers like 18F-FDG and 18F-FET.

In a pilot study involving five human subjects, 18F-FSPG was well tolerated and effectively identified malignant lesions, indicating its potential as a reliable imaging agent for intracranial malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Preclinical and Clinical Evaluation of (4S)-4-(3-[18F]Fluoropropyl)-L-Glutamate (18F-FSPG) for PET/CT Imaging of Intracranial Malignancies. Mittra, ES., Koglin, N., Mosci, C., et al.[2018]

F-FDG PET/CT imaging, while commonly used for cancer diagnosis, can be limited by high glucose uptake in normal tissues like the heart, which can obscure cancer detection.

In a case of non-small cell lung cancer, the investigational radiotracer F-FSPG successfully identified myocardial and pericardial metastases that were missed by F-FDG, highlighting its potential advantages in imaging cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracardiac Metastases Detected by 18F-FSPG PET/CT. Magarik, MA., Walker, RC., Gilbert, J., et al.[2019]

In a study involving 26 patients with indeterminate pulmonary nodules, the new PET radiotracer 18F-FSPG showed similar diagnostic accuracy to the standard 18F-FDG for identifying malignant lesions, detecting cancer in 14 out of 17 cases.

While 18F-FSPG was better at identifying benign lesions (6 out of 9 negative results) compared to 18F-FDG (2 out of 9 negative results), the overall effectiveness of both tracers was comparable, indicating that further research is needed to assess the clinical benefits of using 18F-FSPG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-FSPG PET imaging for the evaluation of indeterminate pulmonary nodules. Paez, R., Shah, C., Cords, AJ., et al.[2022]

The new PET tracer (18)F-FSPG shows promise for detecting malignant diseases, particularly in non-small cell lung cancer, with dosimetry estimates indicating a radiation dose of 9.5 mSv at a standard patient dose of 300 MBq, comparable to (18)F-FDG.

The absorbed dose to the urinary bladder wall was the highest, but this can be significantly reduced by encouraging patients to void their bladder frequently, lowering the effective dose to 4.5 mSv with a 0.75-hour voiding interval.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

(S)-4-(3-18F-fluoropropyl)-L-glutamic acid: an 18F-labeled tumor-specific probe for PET/CT imaging--dosimetry. Smolarz, K., Krause, BJ., Graner, FP., et al.[2016]

The radiopharmaceutical 18F-FSPG demonstrated a high tumor detection rate in prostate cancer patients, with 89% detection on a per-patient basis and 87% on a per-lobe basis, indicating its potential effectiveness for imaging.

In patients with recurrent prostate cancer, 18F-FSPG PET showed good agreement with standard imaging methods in 78% of cases, suggesting it could be a reliable tool for assessing cancer recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Evaluation of (4S)-4-(3-[18F]Fluoropropyl)-L-glutamate (18F-FSPG) for PET/CT Imaging in Patients with Newly Diagnosed and Recurrent Prostate Cancer. Park, SY., Na, SJ., Kumar, M., et al.[2021]

Citations

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[18F]Fluorodeoxyglucose-positron emission tomography ... [18F]Fluorodeoxyglucose (FDG)-positron emission tomography (PET) combined with CT is helpful in the staging, imaging, and prognosis of patients with lung cancer ...

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Surveillance With Fluorine-18 Fluorodeoxyglucose ... In the PET group, 1171 scheduled [18F]FDG PET/CT scans were performed; 345 of 373 patients (92%) underwent PET/CT scans at 6 months after completion of therapy, ...

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Correlation of 18F-fluorodeoxyglucose positron emission ... This study found that PET/CT-related parameters, particularly SUVmax, SUVmean, and SUVtmr, were not effective in accurately distinguishing between the lung ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1556086425006938

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Fludeoxyglucose F 18 Injection - accessdata.fda.gov The studies encompassed a variety of cancers: non-small cell lung cancer ... The Fludeoxyglucose F 18 Injection safety database for epilepsy included of 374 ...

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Fludeoxyglucose (18F) - StatPearls - NCBI Bookshelf - NIH Fludeoxyglucose F18 is a radioactive tracer that acts as a glucose analog and is used for diagnostic purposes in conjunction with positron-emitting tomography ...

8. rxlist.com rxlist.com/fludeoxyglucose-drug.htm

Fludeoxyglucose F 18 Injection (FDG): Side Effects, Uses, ... The [18F]FDG safety data base was evaluated for 374 patients. Of these, 245 ... The studies encompassed a variety of cancers: non-small cell lung cancer ...

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Fludeoxyglucose F-18 PET/CT in Predicting Response to ... This phase II trial studies how well fludeoxyglucose F-18 ( 18F-FDG ) positron emission tomography (PET)/computed tomography (CT) works in predicting ...

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Fludeoxyglucose (18F): Uses, Interactions, Mechanism of ... Fludeoxyglucose (18F) is a radiopharmaceutical agent used for positron emission tomography (PET) imaging in oncology, cardiology, and neurology.