18F-FSPG PET Imaging for Liver Cancer

Overseen By Simone Krebs, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Under 18, Pregnant, Breastfeeding, Uncontrolled diabetes, Psychiatric illness, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

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 positron emission tomography scan) to evaluate its compatibility with Y90 radioembolization therapy for liver cancer. The goal is to determine how effectively this imaging method reveals liver cancer and its response to treatment. It targets individuals with hepatocellular carcinoma (HCC) who qualify for Y90 therapy and have undergone standard imaging tests. This trial may suit those diagnosed with HCC who are eligible for Y90 treatment and have completed standard imaging and staging. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new imaging method.

Do I need to stop taking my current medications to join the trial?

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 is safe for use in PET imaging?

Research shows that specific safety information about 18F-FSPG PET imaging in humans is not yet available. This indicates that while testing this treatment, there is insufficient data to determine its exact safety for people. However, as a Phase 1 clinical trial, the primary goal is to assess its safety and how the body responds. Phase 1 studies typically represent the initial step in testing a new treatment in humans, with a strong emphasis on safety. If 18F-FSPG PET imaging is well-tolerated in this phase, participants may experience fewer side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for liver cancer rely on methods like surgery, chemotherapy, or radioembolization, often aimed at physically removing or destroying tumors. But researchers are excited about 18F-FSPG because it offers a new way to visualize cancer activity through PET imaging. Unlike conventional imaging that may focus on tumor size, 18F-FSPG targets the metabolic activity of cancer cells, potentially offering a clearer picture of how the cancer is functioning. This approach could lead to more personalized and effective treatment strategies by helping doctors understand how liver cancer is behaving before and after treatments.

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

Research has shown that a special type of scan, called 18F-FSPG PET imaging, effectively detects liver cancer, particularly hepatocellular carcinoma (HCC). One study found that more than half of the low-grade HCCs and about 70% of the high-grade tumors exhibited higher protein levels than normal liver tissue. This imaging method detected liver cancer 75% of the time, making it a promising tool for identifying the disease. Early detection allows doctors to better understand the cancer and potentially improve treatment outcomes. Participants in this trial will undergo a baseline investigational 18F-FSPG PET/CT scan to evaluate its effectiveness in detecting liver cancer. ^{1 3 4 5 6}

Who Is on the Research Team?

Simone Krebs, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with hepatocellular carcinoma (HCC) who qualify for Y90 radioembolization therapy. They must have completed standard imaging and staging, agree to use contraception if of child-bearing potential, and be able to consent. Excluded are pregnant or breastfeeding individuals, those not eligible for the therapy, with certain psychiatric or social conditions, allergies to similar compounds, under 18s, or with uncontrolled diabetes.

Inclusion Criteria

I've completed all required scans and staging before the PET study.

I am 18 years old or older.

Agreement to use adequate contraception for women and men of child-bearing potential

Exclusion Criteria

Pregnant and breastfeeding patients

I have liver cancer and cannot have Y90 treatment alone.

Patients with psychiatric illness/social situations limiting compliance

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Participants undergo a baseline investigational 18F-FSPG PET/CT scan within 4 weeks of SOC CT and no more than 2 weeks prior to Y90 treatment

4 weeks

Treatment

Participants receive Y90 radioembolization therapy

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3-, 6-, 9-, and 12-months following the procedure

12 months

What Are the Treatments Tested in This Trial?

Interventions

• 18F-FSPG

Trial Overview The trial tests how well a radiopharmaceutical called 18F-FSPG shows up in HCC lesions during PET scans and correlates these findings with circulating tumor DNA (ctDNA) in blood samples and response to Y90 radioembolization treatment.

How Is the Trial Designed?

Group I: Single Arm Experimental Treatment 1 Intervention

Participants will be scheduled for a baseline investigational 18F-FSPG PET/CT scan within 4 weeks of SOC CT and no more than 2 weeks prior to Y90 treatment.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Citations

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

Utility of [18F]FSPG PET to Image Hepatocellular Carcinoma Over 50 % of low-grade HCCs and ~70 % of high-grade tumors exceeded background liver protein expression. [18F]FSPG PET/CT demonstrated a detection rate of 75 %.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02379377

18F-FSPG PET in Imaging Patients With Liver Cancer ... Tumor grade will be determined from pathology of tissue samples and correlated to PET imaging data for 18F-FSPG, 11C-acetate and 18F-FDG PET.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2531137925000707

DUAL-TRACER PET/CT IMAGING IN HEPATOCELLULAR ... For BCLC-B patients, the median ΔSUVmax was 17.65% (-6.35% to 28.57%) for 18F-FDG and -30.17% (-9.74% to -50.67%) for 18F-PSMA. For BCLC-C patients, the median ...

4. jnm.snmjournals.org jnm.snmjournals.org/content/66/supplement_1/251164

Integrated Dedicated Liver F-18 FDG PET/MR Imaging of ... In this study, we aimed to evaluate the correlations between findings from F-18 FDG PET, DCE MRI, and DWI for HCC lesions. By utilizing late- ...

5. 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 ... Diagnostic procedures, such as 18F-FSPG PET, may help find and diagnose liver cancer and find out how far the disease has spread. Description.

6. withpower.com withpower.com/trial/phase-1-cholangiocarcinoma-9-2021-dfb16

18F-FSPG PET Imaging for Liver Cancer 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 ...