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

15 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well 18F-FSPG positron emission tomography (PET)/computed tomography (CT) work in diagnosing early lung cancer in patients with indeterminate lung nodules. PET imaging with an imaging agent called 18F-FDG is often used in combination with a PET/CT scanner to evaluate cancers. Giving 18F-FSPG before a PET/CT scan may work better in helping researchers diagnose early lung cancer in patients with lung nodules.

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 data supports the effectiveness of this treatment for lung cancer?

Research shows that the imaging agent 18F-FSPG, used in PET/CT scans, has shown promising results in detecting non-small cell lung cancer and can improve diagnostic accuracy compared to traditional methods. It is particularly useful in identifying cancerous tissues that might be missed by other imaging agents like 18F-FDG. ^{1 2 3 4 5}

Is 18F-FSPG PET/CT imaging safe for humans?

18F-FSPG, a tracer used in PET/CT imaging, has been evaluated in studies for various cancers, including lung and brain tumors. These studies suggest it is generally safe for human use, as it has been tested in both preclinical and clinical settings without significant safety concerns reported. ^{2 4 5 6 7}

How is the drug 18F-FSPG PET/CT unique for lung cancer imaging?

18F-FSPG PET/CT is unique because it uses a novel radiotracer that targets a specific pathway associated with glutathione biosynthesis, which can improve the accuracy of detecting cancerous tissues compared to the more commonly used 18F-FDG PET/CT. This makes it particularly useful in distinguishing malignant from benign lung nodules, especially in areas where other conditions like fungal infections might affect results. ^{1 2 4 5 7}

Research Team

Carina Mari Aparici

Principal Investigator

Stanford Cancer Institute Palo Alto

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

18F-FSPG PET imaging for the evaluation of indeterminate pulmonary nodules. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Intracardiac Metastases Detected by 18F-FSPG PET/CT. [2019]

3. United States 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. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

(S)-4-(3-18F-fluoropropyl)-L-glutamic acid: an 18F-labeled tumor-specific probe for PET/CT imaging--dosimetry. [2016]

5. United States 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. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Radiosynthesis and Analysis of (S)-4-(3-[18F]Fluoropropyl)-L-Glutamic Acid. [2023]

7. United States 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. [2018]