Clinical trial · Interventional
18F-FSPG PET in Imaging Patients With Liver Cancer Before Undergoing Surgery or Transplant
PET Imaging of Hepatocellular Carcinoma With 18F-FSPG
NCT02379377CI-TRIAL-00113267active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Hepatocellular Carcinoma | Adult Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Benign Liver Tumor | — | UNRESOLVED | — |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Metastases to Liver | — | UNRESOLVED | — |
| Resectable Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carbon C 11 Acetate | Biological | — | UNRESOLVED |
| Fluorine F 18 2-deoxy-2-(18F)fluoro-D-glucose | Biological | — | UNRESOLVED |
| Fluorine F 18 L-glutamate Derivative 18F-FSPG | Biological | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Positron Emission Tomography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Diagnostic (18F-FSPG PET)
- description
- 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.
- interventionNames
- Biological: Fluorine F 18 L-glutamate Derivative 18F-FSPG
- Procedure: Positron Emission Tomography
- Other: Laboratory Biomarker Analysis
- type
- EXPERIMENTAL
- label
- Diagnostic (11C-Acetate PET or 18F-FDG PET)
- description
- Patients may undergo either carbon-11 (11C)-Acetate PET or 18F-FDG PET scans within 4 weeks of surgery or OLT.
- interventionNames
- Biological: Fluorine F 18 L-glutamate Derivative 18F-FSPG
- Biological: Carbon C 11 Acetate
- Procedure: Positron Emission Tomography
- Other: Laboratory Biomarker Analysis
- Biological: Fluorine F 18 2-deoxy-2-(18F)fluoro-D-glucose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.References
Publications (0)
Data not yet available
No reference posted for this study.