← Back to Search

18F-FSPG PET Imaging for Liver Cancer

Phase 1

Recruiting

Led By Lesley Flynt, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Tumor confirmed by arteriography. or Liver mass (>= 1 cm) that has suggestive imaging findings of a benign liver mass (adenoma, hemangioma, focal nodular hyperplasia).

Patients with HCC or cholangiocarcinoma must be a candidate for liver resection or orthotopic liver transplant (OLT)

Must not have

Patients who have HCC or cholangiocarcinoma but are not candidates for liver resection surgery or OLT

Patients with poorly controlled diabetes mellitus (fasting blood glucose level > 200 mg/dL).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after surgery; through study completion, up to 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how well 18F-FSPG PET works in imaging patients with liver cancer before surgery or transplant. This may help diagnose the cancer and find out how far it has spread.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed in the provided information, typical side effects from PET scans may include discomfort at the injection site of the tracer substance and allergic reactions to it; however these are generally minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I am eligible for liver surgery or a liver transplant due to my liver cancer.

Select...

My liver cancer diagnosis matches specific imaging criteria.

Select...

I have a liver mass over 1 cm confirmed as metastatic cancer from the colon or pancreas.

Select...

My tests show a tumor or my AFP levels are above 200.

Select...

I have a liver tumor larger than 1 cm that is not liver cancer but cholangiocarcinoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

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

Select...

My liver cancer is of the infiltrative type.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after surgery; through study completion, up to 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after surgery; through study completion, up to 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and after surgery; through study completion, up to 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

11C-acetate standardized uptake value (SUV)

18F-FDG standardized uptake value (SUV)

18F-FSPG PET standardized uptake value (SUV)

+7 more

Secondary study objectives

Metabolic profile

Milan classification

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Diagnostic (18F-FSPG PET)Experimental Treatment3 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 Treatment5 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2011

Completed Phase 2

~2200

0 / 10Eligibility criteria met