Trial Outcomes & Findings for 18F-DCFPyL PET/CT in Hepatocellular Carcinoma (NCT NCT05009979)

Last Updated: 2025-08-28

Results Overview

Positive predictive value is defined as the proportion of histopathologically positive lesions. Positron emission tomography (PET) positivity was measured by the maximum standardized uptake (SUVmax) value. The 95% confidence intervals of the positive predictive value of piflufolastat F-18 (18F-DCFPyL) positron emission tomography scan and computed tomography (PET/CT) will be reported in which the confidence limits are the 2.5th and 97.5th percentile of the 2000 bootstrap samples obtained by random sample without replacement at the participant level to account for inter-lesion correlation. For lesions within the liver, a focal abnormal area of increased 18F-DCFPyL activity higher than the surrounding liver uptake (SUVmax more than x 1.2 times than the normal liver-SUV mean) will be considered positive. For lesions outside the liver, a positive lesion is defined as focal abnormal uptake higher than the blood pool or surrounding normal organ or soft tissue background.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

Baseline, post ablation, and disease progression, an average of 3.87 months

Results posted on

2025-08-28

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1, Cohort 1 Baseline and Post-treatment Imaging With Piflufolastat F-18 (18F-DCFPyL) Participants with radiographically confirmed hepatocellular carcinoma. Piflufolastat F-18 (18F-DCFPyL) positron emission tomography and computed tomography (PET/CT) imaging, CT and/or magnetic resonance imaging (MRI) and standard of care local ablative treatment F18-FDG: Within approximately 2 weeks of each piflufolastat F-18 (18F-DCFPyL) positron emission tomography and computed tomography (PET/CT) scan, participants will be scanned with a fludeoxyglucose F 18 (18F-FDG) PET/CT imaging at the National Institutes of Health (NIH) Clinical Center using standard procedures. The 18F-FDG PET/CT imaging performed will allow the localization of viable tumor sites and characterize their fludeoxyglucose-18 (FDG) metabolism for comparison with 18F-DCFPyL imaging. The 18F-FDG PET/CT imaging will consist of an 18F-FDG injection and PET/CT imaging performed approximately 1 hour post 18F-FDG injection. A corresponding low dose CT scan for attenuation correction and co-registration purposes will be performed prior to the PET image.
Overall Study STARTED	8
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1, Cohort 1 Baseline and Post-treatment Imaging With Piflufolastat F-18 (18F-DCFPyL) Participants with radiographically confirmed hepatocellular carcinoma. Piflufolastat F-18 (18F-DCFPyL) positron emission tomography and computed tomography (PET/CT) imaging, CT and/or magnetic resonance imaging (MRI) and standard of care local ablative treatment F18-FDG: Within approximately 2 weeks of each piflufolastat F-18 (18F-DCFPyL) positron emission tomography and computed tomography (PET/CT) scan, participants will be scanned with a fludeoxyglucose F 18 (18F-FDG) PET/CT imaging at the National Institutes of Health (NIH) Clinical Center using standard procedures. The 18F-FDG PET/CT imaging performed will allow the localization of viable tumor sites and characterize their fludeoxyglucose-18 (FDG) metabolism for comparison with 18F-DCFPyL imaging. The 18F-FDG PET/CT imaging will consist of an 18F-FDG injection and PET/CT imaging performed approximately 1 hour post 18F-FDG injection. A corresponding low dose CT scan for attenuation correction and co-registration purposes will be performed prior to the PET image.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

18F-DCFPyL PET/CT in Hepatocellular Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1, Cohort 1, Baseline and Post-treatment Imaging With Piflufolastat F-18 (18F-DCFPyL) n=8 Participants Participants with radiographically confirmed hepatocellular carcinoma. Piflufolastat F-18 (18F-DCFPyL) positron emission tomography and computed tomography (PET/CT) imaging, CT and/or magnetic resonance imaging (MRI) and standard of care local ablative treatment F18-FDG: Within approximately 2 weeks of each piflufolastat F-18 (18F-DCFPyL) positron emission tomography and computed tomography (PET/CT) scan, participants will be scanned with a fludeoxyglucose F 18 (18F-FDG) PET/CT imaging at the National Institutes of Health (NIH) Clinical Center using standard procedures. The 18F-FDG PET/CT imaging performed will allow the localization of viable tumor sites and characterize their fludeoxyglucose-18 (FDG) metabolism for comparison with 18F-DCFPyL imaging. The 18F-FDG PET/CT imaging will consist of an 18F-FDG injection and PET/CT imaging performed approximately 1 hour post 18F-FDG injection. A corresponding low dose CT scan for attenuation correction and co-registration purposes will be performed prior to the PET image.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	70.75 years STANDARD_DEVIATION 10.18 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, post ablation, and disease progression, an average of 3.87 months

Population: 7/8 participants were analyzed because one participant only completed baseline fludeoxyglucose-18 (FDG) PET/CT but did not undergo baseline 18F-DCFPyL or post treatment PET/CT scans. No biopsies at post ablation, and outside the liver were collected because this intervention was not part of the study. No participants had disease progression while on study, therefore no biopsies were collected. We did not scan participants with 18F-DCFPyL at progression/no signs of progression while on study.

Outcome measures

Outcome measures
Measure	Arm 1, Cohort 1, Baseline and Post-treatment Imaging With Piflufolastat F-18 (18F-DCFPyL) n=8 lesions Participants with radiographically confirmed hepatocellular carcinoma. Piflufolastat F-18 (18F-DCFPyL) positron emission tomography and computed tomography (PET/CT) imaging, CT and/or magnetic resonance imaging (MRI) and standard of care local ablative treatment F18-FDG: Within approximately 2 weeks of each piflufolastat F-18 (18F-DCFPyL) positron emission tomography and computed tomography (PET/CT) scan, participants will be scanned with a fludeoxyglucose F 18 (18F-FDG) PET/CT imaging at the National Institutes of Health (NIH) Clinical Center using standard procedures. The 18F-FDG PET/CT imaging performed will allow the localization of viable tumor sites and characterize their fludeoxyglucose-18 (FDG) metabolism for comparison with 18F-DCFPyL imaging. The 18F-FDG PET/CT imaging will consist of an 18F-FDG injection and PET/CT imaging performed approximately 1 hour post 18F-FDG injection. A corresponding low dose CT scan for attenuation correction and co-registration purposes will be performed prior to the PET image.
Positive Predictive Value (PPV) Defined as the Proportion of Histopathology Positive Lesions as Measured by the Maximum Standardized Uptake (SUVmax) Value Lesions within the liver at baseline	0.875 proportion of lesions Interval 0.64 to 1.1

PRIMARY outcome

Timeframe: Baseline, post ablation, disease progression, an average of 3.87 months

Population: 7/8 participants were analyzed because one participant only completed baseline fludeoxyglucose-18 (FDG) PET/CT but did not undergo baseline 18F-DCFPyL or post treatment PET/CT scans. No biopsies at post ablation were collected because this intervention was not part of the study. No participants had disease progression while on study, therefore no biopsies were collected.

Positive predictive value of the DCFPyL PET imaging agent is defined as the proportion of radiologically positive lesions (true positives) that were PET positive, over the radiologically (CT/MRI) positive lesions that were PET positive (true positives) added to the radiologically negative lesions that were PET positive (false positives). Point estimates and 95% confidence intervals of the positive predictive values of piflufolastat F-18 (18F-DCFPyL) positron emission tomography scan and computed tomography (PET/CT) will be reported in which the confidence limits are the 2.5th and 97.5th percentile of the 2000 bootstrap samples obtained by random sample without replacement at the participant level to account for inter-lesion correlation.

Outcome measures

Outcome measures
Measure	Arm 1, Cohort 1, Baseline and Post-treatment Imaging With Piflufolastat F-18 (18F-DCFPyL) n=14 lesions Participants with radiographically confirmed hepatocellular carcinoma. Piflufolastat F-18 (18F-DCFPyL) positron emission tomography and computed tomography (PET/CT) imaging, CT and/or magnetic resonance imaging (MRI) and standard of care local ablative treatment F18-FDG: Within approximately 2 weeks of each piflufolastat F-18 (18F-DCFPyL) positron emission tomography and computed tomography (PET/CT) scan, participants will be scanned with a fludeoxyglucose F 18 (18F-FDG) PET/CT imaging at the National Institutes of Health (NIH) Clinical Center using standard procedures. The 18F-FDG PET/CT imaging performed will allow the localization of viable tumor sites and characterize their fludeoxyglucose-18 (FDG) metabolism for comparison with 18F-DCFPyL imaging. The 18F-FDG PET/CT imaging will consist of an 18F-FDG injection and PET/CT imaging performed approximately 1 hour post 18F-FDG injection. A corresponding low dose CT scan for attenuation correction and co-registration purposes will be performed prior to the PET image.
Point Estimates of the Positive Predictive Value of Piflufolastat F-18 (18F-DCFPyL) Baseline	0.64 proportion of lesions Interval 0.39 to 0.89

SECONDARY outcome

Timeframe: Baseline, post ablation, and disease progression, an average of 3.87 months

Population: 7/8 participants were analyzed because one participant only completed baseline fludeoxyglucose-18 (FDG) PET/CT but did not undergo baseline 18F or post treatment PET/CT scans. No biopsies at post ablation were collected because this intervention was not part of the study or standard of care. No data is available at disease progression because none of the participants showed signs of disease progression while on study.

Lesion level sensitivity is defined as true positive (TP)/\[TP+ false negative (FN\], being TP = true positive lesions (i.e., positron emission tomography (PET) positive lesions that are histologically positive) and FN = false negative lesions (i.e., PET negative lesions that are histologically positive) . The lesion level sensitivity of piflufolastat F-18 (18F-DCFPyL) positron emission tomography scan and a computed tomography (PET/CT) and CT/magnetic resonance imaging (MRI) will be calculated and compared. The confidence interval for each estimate will be obtained from the bootstrap samples and the difference in the estimates between the imaging modalities will be compared by the Wald test with the standard error calculated from the bootstrap samples.

Outcome measures

Outcome measures
Measure	Arm 1, Cohort 1, Baseline and Post-treatment Imaging With Piflufolastat F-18 (18F-DCFPyL) n=14 lesions Participants with radiographically confirmed hepatocellular carcinoma. Piflufolastat F-18 (18F-DCFPyL) positron emission tomography and computed tomography (PET/CT) imaging, CT and/or magnetic resonance imaging (MRI) and standard of care local ablative treatment F18-FDG: Within approximately 2 weeks of each piflufolastat F-18 (18F-DCFPyL) positron emission tomography and computed tomography (PET/CT) scan, participants will be scanned with a fludeoxyglucose F 18 (18F-FDG) PET/CT imaging at the National Institutes of Health (NIH) Clinical Center using standard procedures. The 18F-FDG PET/CT imaging performed will allow the localization of viable tumor sites and characterize their fludeoxyglucose-18 (FDG) metabolism for comparison with 18F-DCFPyL imaging. The 18F-FDG PET/CT imaging will consist of an 18F-FDG injection and PET/CT imaging performed approximately 1 hour post 18F-FDG injection. A corresponding low dose CT scan for attenuation correction and co-registration purposes will be performed prior to the PET image.
Lesion Level Sensitivity Sensitivity with CT/MRI at baseline	1.0 proportion of biopsy lesions Interval 1.0 to 1.0
Lesion Level Sensitivity Sensitivity with 18F-DCFPyL PET/CT at baseline	0.87 proportion of biopsy lesions Interval 0.7 to 1.04

SECONDARY outcome

Timeframe: Baseline, post ablation, and disease progression, an average of 3.87 months

Population: No biopsies at post ablation were collected because this intervention was not part of the study or standard of care. No data is available at disease progression because none of the participants showed signs of disease progression while on study.

Lesion level specificity is defined as true negative (TN)/\[TN+ false positive (FP\], being TN = true negative (i.e., positron emission tomography (PET) negative lesions that are histopathologically negative, and FP = false positive (i.e., PET positive lesions that are histopathologically negative). The lesion level specificity of piflufolastat F-18 (18F-DCFPyL) positron emission tomography scan and a computed tomography (PET/CT) and CT/magnetic resonance imaging (MRI) will be calculated and compared. The confidence interval for each estimate will be obtained from the bootstrap samples and the difference in the estimates between the imaging modalities will be compared by the Wald test with the standard error calculated from the bootstrap samples.

Outcome measures

Outcome measures
Measure	Arm 1, Cohort 1, Baseline and Post-treatment Imaging With Piflufolastat F-18 (18F-DCFPyL) n=14 lesions Participants with radiographically confirmed hepatocellular carcinoma. Piflufolastat F-18 (18F-DCFPyL) positron emission tomography and computed tomography (PET/CT) imaging, CT and/or magnetic resonance imaging (MRI) and standard of care local ablative treatment F18-FDG: Within approximately 2 weeks of each piflufolastat F-18 (18F-DCFPyL) positron emission tomography and computed tomography (PET/CT) scan, participants will be scanned with a fludeoxyglucose F 18 (18F-FDG) PET/CT imaging at the National Institutes of Health (NIH) Clinical Center using standard procedures. The 18F-FDG PET/CT imaging performed will allow the localization of viable tumor sites and characterize their fludeoxyglucose-18 (FDG) metabolism for comparison with 18F-DCFPyL imaging. The 18F-FDG PET/CT imaging will consist of an 18F-FDG injection and PET/CT imaging performed approximately 1 hour post 18F-FDG injection. A corresponding low dose CT scan for attenuation correction and co-registration purposes will be performed prior to the PET image.
Lesion Level Specificity Specificity with CT/MRI at baseline	NA proportion of biopsy lesions Specificity can't be calculated because there are no true negative lesions since biopsies were not performed in non-malignant lesions.
Lesion Level Specificity Specificity with 18F-DCFPyL PET/CT at baseline	NA proportion of biopsy lesions Specificity can't be calculated because there are no true negative lesions since biopsies were not performed in non-malignant lesions.

SECONDARY outcome

Timeframe: Baseline, post ablation, and disease progression, an average of 3.87 months

Lesion level positive predictive value is defined as true positive (TP/\[TP+ false positive (FP\], being TP = true positive (i.e., positron emission tomography (PET) positive lesions that are histopathologically positive) and FP = false positive (i.e., PET positive lesions that are histopathologically negative) . The lesion level positive predictive value of piflufolastat F-18 (18F-DCFPyL) positron emission tomography scan and a computed tomography (PET/CT) and CT/magnetic resonance imaging (MRI) will be calculated and compared. The confidence interval for each estimate will be obtained from the bootstrap samples and the difference in the estimates between the imaging modalities will be compared by the Wald test with the standard error calculated from the bootstrap samples.

Outcome measures

Outcome measures
Measure	Arm 1, Cohort 1, Baseline and Post-treatment Imaging With Piflufolastat F-18 (18F-DCFPyL) n=14 lesions Participants with radiographically confirmed hepatocellular carcinoma. Piflufolastat F-18 (18F-DCFPyL) positron emission tomography and computed tomography (PET/CT) imaging, CT and/or magnetic resonance imaging (MRI) and standard of care local ablative treatment F18-FDG: Within approximately 2 weeks of each piflufolastat F-18 (18F-DCFPyL) positron emission tomography and computed tomography (PET/CT) scan, participants will be scanned with a fludeoxyglucose F 18 (18F-FDG) PET/CT imaging at the National Institutes of Health (NIH) Clinical Center using standard procedures. The 18F-FDG PET/CT imaging performed will allow the localization of viable tumor sites and characterize their fludeoxyglucose-18 (FDG) metabolism for comparison with 18F-DCFPyL imaging. The 18F-FDG PET/CT imaging will consist of an 18F-FDG injection and PET/CT imaging performed approximately 1 hour post 18F-FDG injection. A corresponding low dose CT scan for attenuation correction and co-registration purposes will be performed prior to the PET image.
Lesion Level Positive Predictive Value Positive Predictive Value with CT/MRI at baseline	0.57 proportion of biopsy lesions Interval 0.31 to 0.83
Lesion Level Positive Predictive Value Positive Predictive Value with 18F-DCFPyL PET/CT at baseline	0.50 proportion of biopsy lesions Interval 0.23 to 0.76

SECONDARY outcome

Timeframe: Pre- and post-treatment hepatocellular carcinoma (HCC) 18F-DCFPyL PET scans, an average of 3.2 months.

Population: 7/8 participants were analyzed because one participant only completed baseline fludeoxyglucose-18 (FDG) PET/CT but did not undergo baseline 18F-DCFPyL or post treatment PET/CT scans.

Change in 18F-DCFPyL PET/CT maximum standardized uptake value (SUVmax) between pre- and post-treatment tumor or tumor bed will be compared by paired Wilcoxon test for participants who undergo local treatment for hepatocellular carcinoma. Positive uptake is defined as a focal abnormal area of increased 18F-DCFPyL activity higher than the surrounding liver uptake standard update value (SUV)max more than x 1.2 times than the normal liver-SUV mean). Negative uptake is defined as tumor uptake less than adjacent background soft tissue, or less than blood pool for lymph nodes.

Outcome measures

Outcome measures
Measure	Arm 1, Cohort 1, Baseline and Post-treatment Imaging With Piflufolastat F-18 (18F-DCFPyL) n=7 Participants Participants with radiographically confirmed hepatocellular carcinoma. Piflufolastat F-18 (18F-DCFPyL) positron emission tomography and computed tomography (PET/CT) imaging, CT and/or magnetic resonance imaging (MRI) and standard of care local ablative treatment F18-FDG: Within approximately 2 weeks of each piflufolastat F-18 (18F-DCFPyL) positron emission tomography and computed tomography (PET/CT) scan, participants will be scanned with a fludeoxyglucose F 18 (18F-FDG) PET/CT imaging at the National Institutes of Health (NIH) Clinical Center using standard procedures. The 18F-FDG PET/CT imaging performed will allow the localization of viable tumor sites and characterize their fludeoxyglucose-18 (FDG) metabolism for comparison with 18F-DCFPyL imaging. The 18F-FDG PET/CT imaging will consist of an 18F-FDG injection and PET/CT imaging performed approximately 1 hour post 18F-FDG injection. A corresponding low dose CT scan for attenuation correction and co-registration purposes will be performed prior to the PET image.
Change in Piflufolastat F-18 (18F-DCFPyL) Positron Emission Tomography and Computed Tomography (PET/CT) Maximum Standardized Uptake Value (SUVmax) Between Pre- and Post-treatment Tumor pre-treatment	10.72 SUV Interval 1.88 to 12.6
Change in Piflufolastat F-18 (18F-DCFPyL) Positron Emission Tomography and Computed Tomography (PET/CT) Maximum Standardized Uptake Value (SUVmax) Between Pre- and Post-treatment Tumor post-treatment	4.61 SUV Interval 2.34 to 6.87
Change in Piflufolastat F-18 (18F-DCFPyL) Positron Emission Tomography and Computed Tomography (PET/CT) Maximum Standardized Uptake Value (SUVmax) Between Pre- and Post-treatment Tumor bed pre-treatment	10.72 SUV Interval 1.88 to 12.6
Change in Piflufolastat F-18 (18F-DCFPyL) Positron Emission Tomography and Computed Tomography (PET/CT) Maximum Standardized Uptake Value (SUVmax) Between Pre- and Post-treatment Tumor bed post-treatment	4.61 SUV Interval 2.34 to 6.87

OTHER_PRE_SPECIFIED outcome

Timeframe: Document adverse events from the first study intervention through 3 days after the agent was last administered, an average of 3.87 months

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	Arm 1, Cohort 1, Baseline and Post-treatment Imaging With Piflufolastat F-18 (18F-DCFPyL) n=8 Participants Participants with radiographically confirmed hepatocellular carcinoma. Piflufolastat F-18 (18F-DCFPyL) positron emission tomography and computed tomography (PET/CT) imaging, CT and/or magnetic resonance imaging (MRI) and standard of care local ablative treatment F18-FDG: Within approximately 2 weeks of each piflufolastat F-18 (18F-DCFPyL) positron emission tomography and computed tomography (PET/CT) scan, participants will be scanned with a fludeoxyglucose F 18 (18F-FDG) PET/CT imaging at the National Institutes of Health (NIH) Clinical Center using standard procedures. The 18F-FDG PET/CT imaging performed will allow the localization of viable tumor sites and characterize their fludeoxyglucose-18 (FDG) metabolism for comparison with 18F-DCFPyL imaging. The 18F-FDG PET/CT imaging will consist of an 18F-FDG injection and PET/CT imaging performed approximately 1 hour post 18F-FDG injection. A corresponding low dose CT scan for attenuation correction and co-registration purposes will be performed prior to the PET image.
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)	7 Participants

Adverse Events

Arm 1, Cohort 1, Baseline and Post-treatment Imaging With Piflufolastat F-18 (18F-DCFPyL)

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1, Cohort 1, Baseline and Post-treatment Imaging With Piflufolastat F-18 (18F-DCFPyL) n=8 participants at risk Participants with radiographically confirmed hepatocellular carcinoma. Piflufolastat F-18 (18F-DCFPyL) positron emission tomography and computed tomography (PET/CT) imaging, CT and/or magnetic resonance imaging (MRI) and standard of care local ablative treatment F18-FDG: Within approximately 2 weeks of each piflufolastat F-18 (18F-DCFPyL) positron emission tomography and computed tomography (PET/CT) scan, participants will be scanned with a fludeoxyglucose F 18 (18F-FDG) PET/CT imaging at the National Institutes of Health (NIH) Clinical Center using standard procedures. The 18F-FDG PET/CT imaging performed will allow the localization of viable tumor sites and characterize their fludeoxyglucose-18 (FDG) metabolism for comparison with 18F-DCFPyL imaging. The 18F-FDG PET/CT imaging will consist of an 18F-FDG injection and PET/CT imaging performed approximately 1 hour post 18F-FDG injection. A corresponding low dose CT scan for attenuation correction and co-registration purposes will be performed prior to the PET image.
Gastrointestinal disorders Ascites	12.5% 1/8 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 3.87 months. Adverse Events were monitored/assessed from the first study intervention through 3 days after the agent was last administered, an average of 3.87 months.

Other adverse events

Other adverse events
Measure	Arm 1, Cohort 1, Baseline and Post-treatment Imaging With Piflufolastat F-18 (18F-DCFPyL) n=8 participants at risk Participants with radiographically confirmed hepatocellular carcinoma. Piflufolastat F-18 (18F-DCFPyL) positron emission tomography and computed tomography (PET/CT) imaging, CT and/or magnetic resonance imaging (MRI) and standard of care local ablative treatment F18-FDG: Within approximately 2 weeks of each piflufolastat F-18 (18F-DCFPyL) positron emission tomography and computed tomography (PET/CT) scan, participants will be scanned with a fludeoxyglucose F 18 (18F-FDG) PET/CT imaging at the National Institutes of Health (NIH) Clinical Center using standard procedures. The 18F-FDG PET/CT imaging performed will allow the localization of viable tumor sites and characterize their fludeoxyglucose-18 (FDG) metabolism for comparison with 18F-DCFPyL imaging. The 18F-FDG PET/CT imaging will consist of an 18F-FDG injection and PET/CT imaging performed approximately 1 hour post 18F-FDG injection. A corresponding low dose CT scan for attenuation correction and co-registration purposes will be performed prior to the PET image.
Gastrointestinal disorders Abdominal pain	25.0% 2/8 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 3.87 months. Adverse Events were monitored/assessed from the first study intervention through 3 days after the agent was last administered, an average of 3.87 months.
Investigations Alanine aminotransferase increased	12.5% 1/8 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 3.87 months. Adverse Events were monitored/assessed from the first study intervention through 3 days after the agent was last administered, an average of 3.87 months.
Investigations Alkaline phosphatase increased	37.5% 3/8 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 3.87 months. Adverse Events were monitored/assessed from the first study intervention through 3 days after the agent was last administered, an average of 3.87 months.
Blood and lymphatic system disorders Anemia	37.5% 3/8 • Number of events 4 • All-Cause Mortality was monitored/assessed an average of 3.87 months. Adverse Events were monitored/assessed from the first study intervention through 3 days after the agent was last administered, an average of 3.87 months.
Metabolism and nutrition disorders Anorexia	12.5% 1/8 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 3.87 months. Adverse Events were monitored/assessed from the first study intervention through 3 days after the agent was last administered, an average of 3.87 months.
Investigations Aspartate aminotransferase increased	37.5% 3/8 • Number of events 4 • All-Cause Mortality was monitored/assessed an average of 3.87 months. Adverse Events were monitored/assessed from the first study intervention through 3 days after the agent was last administered, an average of 3.87 months.
Injury, poisoning and procedural complications Bruising	12.5% 1/8 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 3.87 months. Adverse Events were monitored/assessed from the first study intervention through 3 days after the agent was last administered, an average of 3.87 months.
Respiratory, thoracic and mediastinal disorders Cough	12.5% 1/8 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 3.87 months. Adverse Events were monitored/assessed from the first study intervention through 3 days after the agent was last administered, an average of 3.87 months.
General disorders Fatigue	25.0% 2/8 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 3.87 months. Adverse Events were monitored/assessed from the first study intervention through 3 days after the agent was last administered, an average of 3.87 months.
Metabolism and nutrition disorders Hypoalbuminemia	25.0% 2/8 • Number of events 2 • All-Cause Mortality was monitored/assessed an average of 3.87 months. Adverse Events were monitored/assessed from the first study intervention through 3 days after the agent was last administered, an average of 3.87 months.
Metabolism and nutrition disorders Hypokalemia	12.5% 1/8 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 3.87 months. Adverse Events were monitored/assessed from the first study intervention through 3 days after the agent was last administered, an average of 3.87 months.
Metabolism and nutrition disorders Hyponatremia	12.5% 1/8 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 3.87 months. Adverse Events were monitored/assessed from the first study intervention through 3 days after the agent was last administered, an average of 3.87 months.
Investigations Lymphocyte count decreased	37.5% 3/8 • Number of events 4 • All-Cause Mortality was monitored/assessed an average of 3.87 months. Adverse Events were monitored/assessed from the first study intervention through 3 days after the agent was last administered, an average of 3.87 months.
Investigations Neutrophil count decreased	37.5% 3/8 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 3.87 months. Adverse Events were monitored/assessed from the first study intervention through 3 days after the agent was last administered, an average of 3.87 months.
Investigations Platelet count decreased	37.5% 3/8 • Number of events 3 • All-Cause Mortality was monitored/assessed an average of 3.87 months. Adverse Events were monitored/assessed from the first study intervention through 3 days after the agent was last administered, an average of 3.87 months.
Hepatobiliary disorders Portal vein thrombosis	12.5% 1/8 • Number of events 1 • All-Cause Mortality was monitored/assessed an average of 3.87 months. Adverse Events were monitored/assessed from the first study intervention through 3 days after the agent was last administered, an average of 3.87 months.
Investigations White blood cell decreased	87.5% 7/8 • Number of events 9 • All-Cause Mortality was monitored/assessed an average of 3.87 months. Adverse Events were monitored/assessed from the first study intervention through 3 days after the agent was last administered, an average of 3.87 months.

Additional Information

Dr. Esther Mena Gonzalez

National Cancer Institute

Phone: 240-760-6111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place