18F-FSPG PET Imaging for Liver Cancer

Overseen By Simone S Krebs, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Under 18, Pregnant, Diabetes, others

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

Compensation: Varies

Number of Visits: 1

110 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial studies fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) positron emission tomography (PET) in imaging patients with liver cancer before undergoing surgery or transplant. Diagnostic procedures, such as 18F-FSPG PET, may help find and diagnose liver cancer and find out how far the disease has spread.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug 18F-FSPG for liver cancer?

Research shows that 18F-FSPG, a new imaging drug, has been effective in detecting tumors in patients with non-small cell lung cancer and hepatocellular carcinoma (a type of liver cancer). It has been compared to other imaging methods and shows promise in identifying liver cancer, even in patients with other chronic diseases. ^{1 2 3 4 5}

Is 18F-FSPG PET imaging safe for humans?

The available research does not provide specific safety data for 18F-FSPG PET imaging in humans, focusing instead on its use as a diagnostic tool for various cancers. ^{1 2 3 4 5}

How does the drug 18F-FSPG differ from other treatments for liver cancer?

18F-FSPG is unique because it is a PET imaging agent that targets the xC- transporter, allowing for non-invasive imaging of liver cancer. Unlike traditional imaging methods, it can provide insights into the tumor's metabolic activity and redox status, potentially offering more precise detection and characterization of liver tumors. ^{1 2 3 4 5}

Research Team

Simone S Krebs, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with various liver conditions, including cancer and benign tumors, who are candidates for surgery or transplant. They must have specific imaging findings or tumor markers like AFP > 200 mg/dL, and a recent MRI. Excluded are those under 18, pregnant/breastfeeding individuals, certain prior cancers treated within five years, uncontrolled diabetes, and non-candidates for liver surgery.

Inclusion Criteria

My tumor was confirmed by a special blood vessel X-ray or I have a liver mass identified as benign.

I had an MRI for liver cancer (not HCC) within the last 4 weeks.

I have a liver tumor larger than 1 cm, not from primary liver cancer, confirmed by biopsy and recent MRI.

Exclusion Criteria

I have liver cancer and cannot undergo liver surgery or transplant.

I have had cancer before but haven't received chemotherapy in the last 5 years, except for specific non-excluding types.

My fasting blood sugar level is over 200 mg/dL.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Patients undergo 18F-FSPG PET and either carbon-11 (11C)-acetate PET or 18F-FDG PET scans within 4 weeks of surgery or OLT

4 weeks

1-2 visits (in-person)

Surgery/Transplant

Patients undergo liver resection surgery or orthotopic liver transplant

Within 4 weeks of imaging

Follow-up

Participants are monitored for safety and effectiveness after surgery or transplant

Up to 4 years

Treatment Details

Interventions

• Fluorine F 18 L-glutamate Derivative 18F-FSPG

Trial Overview The study tests the effectiveness of a diagnostic PET scan using an imaging agent called 18F-FSPG to detect how far liver cancer has spread before surgery or transplant. It compares this method against standard imaging techniques to improve diagnosis accuracy.

Participant Groups

Group I: Diagnostic (18F-FSPG PET) Experimental Treatment 3 Interventions

Patients undergo an 18F-FSPG PET scan within 4 weeks of surgery or OLT. Patients may also receive a second 18F-FSPG PET scan following standard-of-care treatment.

Group II: Diagnostic (11C-Acetate PET or 18F-FDG PET) Experimental Treatment 5 Interventions

Patients may undergo either carbon-11 (11C)-Acetate PET or 18F-FDG PET scans within 4 weeks of surgery or OLT.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

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 pilot study demonstrated that [18F]FSPG PET/CT has a 75% detection rate for hepatocellular carcinoma (HCC), outperforming standard imaging techniques in identifying tumors, especially those lacking typical MRI enhancement patterns.

In a comparison with [11C]acetate PET/CT, [18F]FSPG PET/CT showed significantly higher tumor-to-liver background ratios, suggesting it may provide better imaging quality and insights into HCC tumor metabolism, warranting further investigation in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of [18F]FSPG PET to Image Hepatocellular Carcinoma: First Clinical Evaluation in a US Population. Kavanaugh, G., Williams, J., Morris, AS., et al.[2019]

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 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]

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]

References

1. 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]

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

Utility of [18F]FSPG PET to Image Hepatocellular Carcinoma: First Clinical Evaluation in a US Population. [2019]

3. 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]

4. 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]

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

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