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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after surgery; through study completion, up to 4 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
11C-acetate standardized uptake value (SUV)
18F-FDG standardized uptake value (SUV)
18F-FSPG PET standardized uptake value (SUV)
+7 moreSecondary outcome measures
Metabolic profile
Milan classification
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
2008
Completed Phase 2
~2240
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,925,896 Total Patients Enrolled
104 Trials studying Liver Cancer
26,668 Patients Enrolled for Liver Cancer
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,211 Total Patients Enrolled
22 Trials studying Liver Cancer
9,411 Patients Enrolled for Liver Cancer
Lesley Flynt, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
13 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have liver cancer and cannot undergo liver surgery or transplant.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.I have completed all required scans and staging before starting the PET studies.I have had cancer before but haven't received chemotherapy in the last 5 years, except for specific non-excluding types.I am eligible for liver surgery or a liver transplant due to my liver cancer.My tumor grew by at least 50% in size in less than 6 months and does not have specific features like 'washout' or 'capsule'.My liver cancer diagnosis matches specific imaging criteria.I had an MRI for a benign liver issue within the last 4 weeks.I have a liver mass over 1 cm confirmed as metastatic cancer from the colon or pancreas.I have a benign liver tumor confirmed by an MRI within the last 4 weeks.My fasting blood sugar level is over 200 mg/dL.The lesion is at least 20 mm in size with one or more additional major features according to LI-RADS criteria ("washout", enhancing "capsule", or threshold growth).My tests show a tumor or my AFP levels are above 200.My liver cancer is of the infiltrative type.I have a liver tumor larger than 1 cm that is not liver cancer but cholangiocarcinoma.A lesion that is between 10 and 19 millimeters with at least two major features according to the LI-RADS criteria is classified as a type III lesionThe patient has a 10-19 mm mass with no evidence of a capsule or threshold growth at the antecedent ultrasound (US).I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic (18F-FSPG PET)
- Group 2: Diagnostic (11C-Acetate PET or 18F-FDG PET)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Laboratory Biomarker Analysis compliant with FDA regulations?
"The safety of Laboratory Biomarker Analysis is projected to be a 1 due its status as a Phase 1 trial, indicating restricted data regarding both efficacy and security."
Answered by AI
What particular applications does Laboratory Biomarker Analysis have?
"Laboratory Biomarker Analysis is frequently employed for coronary artery disease (CAD) treatment, and may also be beneficial to those suffering from malignancies, positron emission tomography, or left ventricular dysfunction."
Answered by AI
How many participants have enrolled in this clinical inquiry?
"Affirmative. According to clinicaltrials.gov, this experiment is still enrolling participants after its original posting date of February 15th 2022 and last edited date of September 6th 2022. A total of 80 patients will be admitted at a single medical location for the trial."
Answered by AI
Has Laboratory Biomarker Analysis been investigated in other research projects?
"Twenty-two clinical trials are currently underway to investigate Laboratory Biomarker Analysis. Of these, two have progressed to the 3rd phase of research. These studies can be found in many locations across New york State, for a total of 27 sites now involved in this treatment's investigation."
Answered by AI
Are enrolment opportunities still available for this research trial?
"Clinicaltrials.gov reports that this clinical trial is actively seeking participants and has been ever since it was uploaded on February 15th, 2022. The page was last revised on September 6th, 2022."
Answered by AI
Who else is applying?
What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
MD Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
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