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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new imaging method called 18F-FSPG PET, a type of PET scan, to help diagnose liver cancer and assess its spread. Patients will undergo this special PET scan, which may be more effective in detecting liver cancer than other imaging methods. Some participants may also receive additional PET scans using different compounds for comparison. The trial seeks individuals diagnosed with liver cancer or certain other liver conditions who are planning surgery or a liver transplant. Participants should have completed standard imaging tests before joining the trial. As a Phase 1 trial, this research aims to understand how this new imaging method works in people, offering participants the opportunity to be among the first to benefit from this innovative diagnostic approach.

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 prior data suggests that 18F-FSPG PET imaging is safe for liver cancer patients?

Research has shown that 18F-FSPG, a special substance used in PET scans, helps detect liver cancer. Patients in these studies have generally tolerated 18F-FSPG well. Reports of side effects are rare, and no serious health issues have been directly linked to the substance. As this is a Phase 1 trial, the main goal is to ensure safety. Early results suggest that 18F-FSPG is safe for imaging, but further research is needed to confirm this. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 18F-FSPG PET imaging for liver cancer because it offers a novel way to visualize tumors using a fluorine-based compound that targets glutamate transport in cancer cells. Unlike standard PET scans that often use fluorodeoxyglucose (FDG) to highlight metabolic activity, 18F-FSPG focuses on a different metabolic pathway, which might provide clearer images of liver tumors. This new technique could lead to more accurate diagnoses and better treatment planning, potentially improving outcomes for patients with liver cancer.

What evidence suggests that 18F-FSPG PET is effective for imaging liver cancer?

Research has shown that the 18F-FSPG PET scan, one of the diagnostic methods studied in this trial, offers a promising way to image liver cancer. It uses fluorine F 18 L-glutamate to highlight cancer cells during the scan. Early findings suggest this method can effectively detect liver cancer and assess its spread. This approach targets specific cancer-related activities, potentially making it more accurate than some traditional scans. Although still under study, early results are encouraging for improving liver cancer diagnosis. Another diagnostic method in this trial involves either carbon-11 (11C)-Acetate PET or 18F-FDG PET scans, which are also being evaluated for their effectiveness in imaging liver cancer. ^{1 3 5 6 7}

Who Is on the Research Team?

Simone S Krebs, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02379377

18F-FSPG PET in Imaging Patients With Liver Cancer ... This clinical trial studies fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) positron emission tomography (PET) in imaging ...

2. mdanderson.org mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2020-1084.html

PET Imaging of Hepatocellular Carcinoma with 18F-FSPG This clinical trial studies fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) positron emission tomography (PET) in imaging patients with liver cancer ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5641676/

Utility of [18F]FSPG PET to Image Hepatocellular Carcinoma This pilot study evaluated the feasibility of (4S)-4-(3-[18F]fluoropropyl)-L-glutamic acid ([18F]FSPG) positron emission tomography (PET)/X-ray computed ...

4. withpower.com withpower.com/trial/phase-1-cholangiocarcinoma-9-2021-dfb16?condition=EBD+Cancer&overallStatus=Recruiting&hasNoPlacebo=false

18F-FSPG PET Imaging for Liver Cancer This clinical trial studies fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) positron emission tomography (PET) in imaging patients with liver ...

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2015-00184

18F-FSPG PET in Imaging Patients with Liver ... This phase I trial studies fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) positron emission tomography (PET) in imaging patients with liver cancer.

6. trialx.com trialx.com/clinical-trials/listings/226037/18f-fspg-pet-in-imaging-patients-with-liver-cancer-before-undergoing-surgery-or-transplant/

18F-FSPG PET in Imaging Patients With Liver Cancer ... This clinical trial studies fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) positron emission tomography (PET) in imaging ...

7. jnm.snmjournals.org jnm.snmjournals.org/content/54/1/117

(4S)-4-(3- 18 F-Fluoropropyl)-l-Glutamate for Imaging of x C ... The aim of this study was to explore the tumor detection rate of 18F-FSPG, compared with that of 18F-FDG, in patients with hepatocellular ...