RECRUITING

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

Conditions

Adult Hepatocellular Carcinoma Resectable Hepatocellular Carcinoma Cholangiocarcinoma Benign Liver Tumor Metastases to Liver

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

PET Imaging of Hepatocellular Carcinoma With 18F-FSPG

Quick Facts

Study Start:2022-02-15

Study Completion:2025-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02379377

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. 5. Each patient must have completed conventional imaging and staging and MRI or CT before initiation of the investigational PET studies. 6. Participants with HCC must be a candidate for liver resection, orthotopic liver transplant (OLT), or Y90 radioembolization.	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.

Inclusion Criteria

Exclusion 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.
5. Each patient must have completed conventional imaging and staging and MRI or CT before initiation of the investigational PET studies.
6. Participants with HCC must be a candidate for liver resection, orthotopic liver transplant (OLT), or Y90 radioembolization.

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.

Contacts and Locations

Study Contact

Lesley Flynt, MD

CONTACT

713-745-8760

lflynt@mdanderson.org

Principal Investigator

Lesley Flynt, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

MD Anderson Cancer Center

Houston, Texas, 77090

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Lesley Flynt, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-15

Study Completion Date2025-05-31

Study Record Updates

Study Start Date2022-02-15

Study Completion Date2025-05-31

Terms related to this study

Additional Relevant MeSH Terms

Adult Hepatocellular Carcinoma
Resectable Hepatocellular Carcinoma
Cholangiocarcinoma
Benign Liver Tumor
Metastases to Liver