RecruitingPhase 1

18F-FSPG PET in Imaging Patients With Liver Cancer Before Undergoing Surgery or Transplant

United States110 participantsStarted 2022-02-15

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Diagnosis of HCC with one or more of the following:
✓. Liver mass with non-rim arterial phase hyperenhancement (APHE) and one of the following: 1) 10-19 mm with ≥2 additional major features according to LI-RADS criteria ("washout", enhancing "capsule", and/or threshold growth), 2) 10-19 mm with "washout" and visibility at antecedent ultrasound (US) but with no "capsule" or threshold growth, 3) 10-19 mm with ≥50% size increase in ≤6 months but with no "washout" or "capsule" or 4) ≥20 mm with ≥1 additional major feature according to LI-RADS criteria ("washout", enhancing "capsule", or threshold growth).
✓. Lesions that meet LI-RADS 4 criteria or
✓. Lesions that meet LI-RADS 5 criteria or
✓. Suggestive imaging findings plus AFP \> 200 mg/dL or
✓. Tumor confirmed by arteriography or
✓. Pathologic confirmation of tumor or
✓. Diagnosis of a benign abdominal or pelvic tumor with the following characteristics:

Exclusion criteria

✕. Participants under the age of 18 will be excluded from this study.
✕. Participants who have HCC or cholangiocarcinoma but are not candidates for liver resection surgery or OLT, or Y90 radioembolization.
✕. Pregnant and breastfeeding patients. Adequate birth control measures (oral, implanted, or barrier methods) must be used by all female participants of childbearing potential until all research PET scans are completed. Female participants of childbearing potential must have a negative serum or urine pregnancy test within 24 hours of the proposed investigational PET/CT scan(s) prior to injection of the investigational radiopharmaceutical.

What they're measuring

18F-FSPG PET standardized uptake value (SUV)

Timeframe: Within 4 weeks of standard-of-care imaging, within 4 weeks of liver resection surgery, within 12 months of orthotopic liver transplant and prior to therapy

11C-acetate standardized uptake value (SUV)

Timeframe: Within 4 weeks of standard-of-care imaging, within 4 weeks of liver resection surgery, within 12 months of orthotopic liver transplant and prior to therapy

18F-FDG standardized uptake value (SUV)

Timeframe: Within 4 weeks of standard-of-care imaging, within 4 weeks of liver resection surgery, within 12 months of orthotopic liver transplant and prior to therapy

Pharmacokinetics of 18F-FSPG, 11C-acetate, and 18F-FDG

Timeframe: Within 4 weeks of standard-of-care imaging, within 4 weeks of liver resection surgery, within 12 months of orthotopic liver transplant and prior to therapy

Number of lesions

Timeframe: Within 4 weeks of liver resection surgery, within 12 months of orthotopic liver transplant and prior to therapy

Sensitivity of 18F-FSPG PET imaging

Timeframe: Within 4 weeks of standard-of-care imaging, within 4 weeks of liver resection surgery, within 12 months of orthotopic liver transplant and prior to therapy

Trial details

NCT IDNCT02379377

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05-31

Contact for this trial

Simone S Krebs, MD

713-563-6726 SSKrebs@mdanderson.org

View on ClinicalTrials.gov More Adult Hepatocellular Carcinoma trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Diagnosis of HCC with one or more of the following:
✓. Liver mass with non-rim arterial phase hyperenhancement (APHE) and one of the following: 1) 10-19 mm with ≥2 additional major features according to LI-RADS criteria ("washout", enhancing "capsule", and/or threshold growth), 2) 10-19 mm with "washout" and visibility at antecedent ultrasound (US) but with no "capsule" or threshold growth, 3) 10-19 mm with ≥50% size increase in ≤6 months but with no "washout" or "capsule" or 4) ≥20 mm with ≥1 additional major feature according to LI-RADS criteria ("washout", enhancing "capsule", or threshold growth).
✓. Lesions that meet LI-RADS 4 criteria or
✓. Lesions that meet LI-RADS 5 criteria or
✓. Suggestive imaging findings plus AFP \> 200 mg/dL or
✓. Tumor confirmed by arteriography or
✓. Pathologic confirmation of tumor or
✓. Diagnosis of a benign abdominal or pelvic tumor with the following characteristics:

Exclusion criteria

✕. Participants under the age of 18 will be excluded from this study.
✕. Participants who have HCC or cholangiocarcinoma but are not candidates for liver resection surgery or OLT, or Y90 radioembolization.
✕. Pregnant and breastfeeding patients. Adequate birth control measures (oral, implanted, or barrier methods) must be used by all female participants of childbearing potential until all research PET scans are completed. Female participants of childbearing potential must have a negative serum or urine pregnancy test within 24 hours of the proposed investigational PET/CT scan(s) prior to injection of the investigational radiopharmaceutical.

What they're measuring

18F-FSPG PET standardized uptake value (SUV)

Timeframe: Within 4 weeks of standard-of-care imaging, within 4 weeks of liver resection surgery, within 12 months of orthotopic liver transplant and prior to therapy

11C-acetate standardized uptake value (SUV)

Timeframe: Within 4 weeks of standard-of-care imaging, within 4 weeks of liver resection surgery, within 12 months of orthotopic liver transplant and prior to therapy

18F-FDG standardized uptake value (SUV)

Timeframe: Within 4 weeks of standard-of-care imaging, within 4 weeks of liver resection surgery, within 12 months of orthotopic liver transplant and prior to therapy

Pharmacokinetics of 18F-FSPG, 11C-acetate, and 18F-FDG

Timeframe: Within 4 weeks of standard-of-care imaging, within 4 weeks of liver resection surgery, within 12 months of orthotopic liver transplant and prior to therapy

Number of lesions

Timeframe: Within 4 weeks of liver resection surgery, within 12 months of orthotopic liver transplant and prior to therapy

Sensitivity of 18F-FSPG PET imaging

Timeframe: Within 4 weeks of standard-of-care imaging, within 4 weeks of liver resection surgery, within 12 months of orthotopic liver transplant and prior to therapy