New PET tracer could sharpen liver cancer diagnosis before surgery

NCT ID NCT02379377

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new imaging agent called 18F-FSPG to see if it can better detect liver cancer (hepatocellular carcinoma) and other liver tumors compared to standard PET scans. About 110 adults with liver cancer or benign liver tumors will receive the tracer before their scheduled surgery or transplant. The goal is to improve how doctors find and diagnose liver cancer, which could lead to more accurate treatment planning.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2022

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Diagnosis of HCC with one or more of the following: 1. 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). 2. Lesions that meet LI-RADS 4 criteria or 3. Lesions that meet LI-RADS 5 criteria or 4. Suggestive imaging findings plus AFP \> 200 mg/dL or 5. Tumor confirmed by arteriography or 6. Pathologic confirmation of tumor or 2. Diagnosis of a benign abdominal or pelvic tumor with the following characteristics: 1. Liver mass (≥ 1 cm) that has suggestive imaging findings of a benign liver mass (adenoma, hemangioma, focal nodular hyperplasia). 2. Prior SOC MRI or CT of the benign lesion within 8 weeks of enrollment or 3. Diagnosis of a malignant non-HCC liver tumor with one or more of the following characteristics: 1. Liver mass (≥ 1 cm) that is biopsy proven, MRI-confirmed, or CT-confirmed metastatic disease (metastatic colorectal cancer, metastatic pancreatic cancer). 2. Liver mass (≥ 1 cm) that is a non-HCC primary malignancy (cholangiocarcinoma). 3. Prior SOC MRI or CT of the malignant non-HCC liver tumor within 8 weeks of enrollment or 4. Diagnosis of oligometastatic solid tumors in the following disease sites: colorectal, sarcoma, lung, head and neck, ovarian, renal, melanoma, pancreatic, prostate, cervix, breast, uterine and cholangiocarcinoma undergoing local consolidative therapy. and 5. Each patient must have completed conventional imaging and staging and MRI or CT before initiation of the investigational PET studies. and 6. Participants with HCC must be a candidate for liver resection, orthotopic liver transplant (OLT), or Y90 radioembolization. Exclusion Criteria: 1. Participants under the age of 18 will be excluded from this study. 2. Participants who have HCC or cholangiocarcinoma but are not candidates for liver resection surgery or OLT, or Y90 radioembolization. 3. 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. 4. Participants with poorly controlled diabetes mellitus (fasting blood glucose level \> 200 mg/dL). 5. Participants with a known Infiltrative variant of HCC.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • MD Anderson Cancer Center

    Houston, Texas, 77090, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.