18F-DCFPyL PET/CT in Hepatocellular Carcinoma

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.

Time frame: 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 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.

Time frame: 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.

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.

Time frame: 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.

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.

Time frame: 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 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.

Time frame: 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 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.

Time frame: 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.

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.

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