Trial Outcomes & Findings for PET/CT in Diagnosing Patients With Liver Cancer Undergoing Surgical Resection (NCT NCT01395030)
NCT ID: NCT01395030
Last Updated: 2018-09-26
Results Overview
Area under the receiver operating characteristic curve for detecting resectable hepatocellular carcinoma with prognostically favorable molecular features (Hoshida molecular sub-class S3) based on FCH PET/CT measurement of tumor maximum standardized uptake value (SUVmax).
COMPLETED
PHASE2
64 participants
Up to study completion at an average of 2.5 years
2018-09-26
Participant Flow
Participant milestones
| Measure |
18F-fluoromethylcholine PET/CT
Patients undergo fluorine-18 (18F-) fluoromethylcholine (FCH) positron emission tomography (PET)/ computed tomography (CT) scan within 14 days of surgical resection.
Computed Tomography: Undergo FCH PET/CT
18F-fluoromethylcholine: Undergo FCH PET/CT
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo FCH PET/CT
|
|---|---|
|
Overall Study
STARTED
|
64
|
|
Overall Study
Complete FCH PET/CT
|
57
|
|
Overall Study
Adequate Tissue for Analysis
|
50
|
|
Overall Study
COMPLETED
|
57
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
18F-fluoromethylcholine PET/CT
Patients undergo fluorine-18 (18F-) fluoromethylcholine (FCH) positron emission tomography (PET)/ computed tomography (CT) scan within 14 days of surgical resection.
Computed Tomography: Undergo FCH PET/CT
18F-fluoromethylcholine: Undergo FCH PET/CT
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo FCH PET/CT
|
|---|---|
|
Overall Study
Did not complete FCH PET/CT
|
7
|
Baseline Characteristics
PET/CT in Diagnosing Patients With Liver Cancer Undergoing Surgical Resection
Baseline characteristics by cohort
| Measure |
18F-fluoromethylcholine PET/CT
n=57 Participants
Patients undergo 18F-fluoromethylcholine PET/CT scan within 14 days of surgical resection.
Computed Tomography: Undergo FCH PET/CT
18F-fluoromethylcholine: Undergo FCH PET/CT
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo FCH PET/CT
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
56 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
57 Participants
n=5 Participants
|
|
Tumor Diagnosis
Hepatocellular carcinoma
|
48 Participants
n=5 Participants
|
|
Tumor Diagnosis
Cholangiocarcinoma
|
8 Participants
n=5 Participants
|
|
Tumor Diagnosis
Sarcoma
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to study completion at an average of 2.5 yearsPopulation: Patients from whom surgical tumor resection (ie. partial hepatectomy) provided adequate tumor and liver samples for tissue analysis.
Area under the receiver operating characteristic curve for detecting resectable hepatocellular carcinoma with prognostically favorable molecular features (Hoshida molecular sub-class S3) based on FCH PET/CT measurement of tumor maximum standardized uptake value (SUVmax).
Outcome measures
| Measure |
18F-fluoromethylcholine PET/CT
n=50 Participants
Patients undergo fluorine-18 (18F-) fluoromethylcholine (FCH) positron emission tomography (PET)/ computed tomography (CT) scan within 14 days of surgical resection.
Computed Tomography: Undergo FCH PET/CT
18F-fluoromethylcholine: Undergo FCH PET/CT
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo FCH PET/CT
|
|---|---|
|
Fluorine-18 (18F) Fluoromethylcholine (FCH) PET/CT Parameters for Assessing Hepatocellular Carcinoma (HCC): Area Under the Receiver Operating Characteristic Curve.
All primary liver cancers (n=50)
|
0.87 unitless
|
|
Fluorine-18 (18F) Fluoromethylcholine (FCH) PET/CT Parameters for Assessing Hepatocellular Carcinoma (HCC): Area Under the Receiver Operating Characteristic Curve.
HCC only (n=41)
|
0.80 unitless
|
PRIMARY outcome
Timeframe: Up to study completion at an average of 2.5 yearsPopulation: Patients from whom surgical tumor resection (ie. partial hepatectomy) provided adequate tumor and liver samples for tissue analysis.
Sensitivity and specificity estimated at a predefined point (ie. Youden's maxima) on the receiver operating characteristic curve for detecting hepatocellular carcinoma with prognostically favorable molecular features (Hoshida molecular sub-class S3) based on FCH PET/CT measurement of tumor maximum standardized uptake value (SUVmax) in patients who underwent subsequent tumor resection.
Outcome measures
| Measure |
18F-fluoromethylcholine PET/CT
n=50 Participants
Patients undergo fluorine-18 (18F-) fluoromethylcholine (FCH) positron emission tomography (PET)/ computed tomography (CT) scan within 14 days of surgical resection.
Computed Tomography: Undergo FCH PET/CT
18F-fluoromethylcholine: Undergo FCH PET/CT
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo FCH PET/CT
|
|---|---|
|
Fluorine-18 (18F) Fluoromethylcholine (FCH) PET/CT Parameters for Assessing Hepatocellular Carcinoma (HCC): Sensitivity/Specificity
Sensitivity for HCC sub-class S3
|
100 percentage of analyzed participants
|
|
Fluorine-18 (18F) Fluoromethylcholine (FCH) PET/CT Parameters for Assessing Hepatocellular Carcinoma (HCC): Sensitivity/Specificity
Specificity for HCC sub-class S3
|
73 percentage of analyzed participants
|
PRIMARY outcome
Timeframe: Up to study completion at an average of 2.5 yearsPopulation: Patients with histopathologically confirmed HCC who completed FCH PET/CT followed by completion of whole-genome expression array analysis of tumor and adjacent liver tissue obtained following partial hepatectomy.
Statistically significant enrichment by sets of genes corresponding to previously-defined molecular pathway signatures was assessed by gene set enrichment analysis (a publicly available algorithm) of whole-genome expression array data obtained from tumors previously characterized by FCH PET/CT. Statistical significance was based on a false discovery rate \< 0.05. Tumors demonstrating high choline metabolism (defined by a tumor-liver ratio \> 1.0 measured on PET) were assessed for enrichment by publicly-available gene sets. This particular analysis involved the entire Molecular Hallmarks gene signature collection (v6.0) as obtained from the Broad Institute Molecular Signature Database (MSigDB).
Outcome measures
| Measure |
18F-fluoromethylcholine PET/CT
n=41 Participants
Patients undergo fluorine-18 (18F-) fluoromethylcholine (FCH) positron emission tomography (PET)/ computed tomography (CT) scan within 14 days of surgical resection.
Computed Tomography: Undergo FCH PET/CT
18F-fluoromethylcholine: Undergo FCH PET/CT
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo FCH PET/CT
|
|---|---|
|
Statistical Significance of Molecular Pathways Associated With Choline Metabolism as Identified Through Gene Set Enrichment Analysis of Hepatocellular Carcinoma (HCC) Tumor Samples.
HALLMARK_OXIDATIVE_PHOSPHORYLATION
|
0.009 false discovery rate
|
|
Statistical Significance of Molecular Pathways Associated With Choline Metabolism as Identified Through Gene Set Enrichment Analysis of Hepatocellular Carcinoma (HCC) Tumor Samples.
HALLMARK_ADIPOGENESIS
|
0.012 false discovery rate
|
|
Statistical Significance of Molecular Pathways Associated With Choline Metabolism as Identified Through Gene Set Enrichment Analysis of Hepatocellular Carcinoma (HCC) Tumor Samples.
HALLMARK_PEROXISOME
|
0.012 false discovery rate
|
|
Statistical Significance of Molecular Pathways Associated With Choline Metabolism as Identified Through Gene Set Enrichment Analysis of Hepatocellular Carcinoma (HCC) Tumor Samples.
HALLMARK_XENOBIOTIC_METABOLISM
|
0.014 false discovery rate
|
|
Statistical Significance of Molecular Pathways Associated With Choline Metabolism as Identified Through Gene Set Enrichment Analysis of Hepatocellular Carcinoma (HCC) Tumor Samples.
HALLMARK_FATTY_ACID_METABOLISM
|
0.015 false discovery rate
|
|
Statistical Significance of Molecular Pathways Associated With Choline Metabolism as Identified Through Gene Set Enrichment Analysis of Hepatocellular Carcinoma (HCC) Tumor Samples.
HALLMARK_BILE_ACID_METABOLISM
|
0.016 false discovery rate
|
PRIMARY outcome
Timeframe: Up to 1 yearPopulation: Number of subjects with available peri-tumoral liver histopathology data
Odds ratios and 95% confidence intervals for histologic liver fibrosis (Metavir) stage \>= F1, \>= F2, \>= F3, and F4 at liver standardized uptake value (SUV) thresholds of 8.3, 8.0, 7.4, and 6.4, respectively. Reference: PMID 29315063.
Outcome measures
| Measure |
18F-fluoromethylcholine PET/CT
n=48 Participants
Patients undergo fluorine-18 (18F-) fluoromethylcholine (FCH) positron emission tomography (PET)/ computed tomography (CT) scan within 14 days of surgical resection.
Computed Tomography: Undergo FCH PET/CT
18F-fluoromethylcholine: Undergo FCH PET/CT
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo FCH PET/CT
|
|---|---|
|
Clinical Liver Disease Severity Based on Liver Fibrosis (Metavir) Stage
Fibrosis stage >= F1
|
3.03 odds ratio
Interval 1.59 to 5.88
|
|
Clinical Liver Disease Severity Based on Liver Fibrosis (Metavir) Stage
Fibrosis stage >= F2
|
5.29 odds ratio
Interval 1.79 to 7.69
|
|
Clinical Liver Disease Severity Based on Liver Fibrosis (Metavir) Stage
Fibrosis stage >= F3
|
5.56 odds ratio
Interval 1.85 to 16.7
|
|
Clinical Liver Disease Severity Based on Liver Fibrosis (Metavir) Stage
Fibrosis stage F4
|
6.67 odds ratio
Interval 1.33 to 33.3
|
PRIMARY outcome
Timeframe: Up to study completion at an average of 2.5 yearsPopulation: Patients who underwent FCH PET/CT followed by histopathologic confirmation of the tumor
HCC tumors were sub-classified using gene expression arrays into 3 distinct prognostically-relevant molecular sub-classes (S1,S2, S3, where S3 is associated with the most favorable clinical prognosis) based on Hoshida et. al (PMID 19723656). The number of tumors comprising two distinct PET/CT imaging phenotypes (high FCH uptake vs. low FCH uptake) was compared between the different sub-classes.
Outcome measures
| Measure |
18F-fluoromethylcholine PET/CT
n=50 Participants
Patients undergo fluorine-18 (18F-) fluoromethylcholine (FCH) positron emission tomography (PET)/ computed tomography (CT) scan within 14 days of surgical resection.
Computed Tomography: Undergo FCH PET/CT
18F-fluoromethylcholine: Undergo FCH PET/CT
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo FCH PET/CT
|
|---|---|
|
Number of Participants Comprising Two Distinct PET/CT Imaging Phenotypes (High FCH Uptake vs. Low FCH Uptake) Between the Different Tumor Sub-classes
HCC sub-class S1 · High FCH uptake
|
7 Participants
|
|
Number of Participants Comprising Two Distinct PET/CT Imaging Phenotypes (High FCH Uptake vs. Low FCH Uptake) Between the Different Tumor Sub-classes
HCC sub-class S1 · Low FCH uptake
|
6 Participants
|
|
Number of Participants Comprising Two Distinct PET/CT Imaging Phenotypes (High FCH Uptake vs. Low FCH Uptake) Between the Different Tumor Sub-classes
HCC sub-class S2 · High FCH uptake
|
0 Participants
|
|
Number of Participants Comprising Two Distinct PET/CT Imaging Phenotypes (High FCH Uptake vs. Low FCH Uptake) Between the Different Tumor Sub-classes
HCC sub-class S2 · Low FCH uptake
|
4 Participants
|
|
Number of Participants Comprising Two Distinct PET/CT Imaging Phenotypes (High FCH Uptake vs. Low FCH Uptake) Between the Different Tumor Sub-classes
HCC sub-class S3 · High FCH uptake
|
24 Participants
|
|
Number of Participants Comprising Two Distinct PET/CT Imaging Phenotypes (High FCH Uptake vs. Low FCH Uptake) Between the Different Tumor Sub-classes
HCC sub-class S3 · Low FCH uptake
|
0 Participants
|
|
Number of Participants Comprising Two Distinct PET/CT Imaging Phenotypes (High FCH Uptake vs. Low FCH Uptake) Between the Different Tumor Sub-classes
Intrahepatic cholangiocarcinoma · High FCH uptake
|
0 Participants
|
|
Number of Participants Comprising Two Distinct PET/CT Imaging Phenotypes (High FCH Uptake vs. Low FCH Uptake) Between the Different Tumor Sub-classes
Intrahepatic cholangiocarcinoma · Low FCH uptake
|
8 Participants
|
|
Number of Participants Comprising Two Distinct PET/CT Imaging Phenotypes (High FCH Uptake vs. Low FCH Uptake) Between the Different Tumor Sub-classes
Primary sarcoma · High FCH uptake
|
0 Participants
|
|
Number of Participants Comprising Two Distinct PET/CT Imaging Phenotypes (High FCH Uptake vs. Low FCH Uptake) Between the Different Tumor Sub-classes
Primary sarcoma · Low FCH uptake
|
1 Participants
|
Adverse Events
18F-fluoromethylcholine PET/CT
Serious adverse events
| Measure |
18F-fluoromethylcholine PET/CT
n=64 participants at risk
Patients undergo 18F-fluoromethylcholine PET/CT scan within 14 days of surgical resection.
Computed Tomography: Undergo FCH PET/CT
18F-fluoromethylcholine: Undergo FCH PET/CT
Laboratory Biomarker Analysis: Correlative studies
Positron Emission Tomography: Undergo FCH PET/CT
|
|---|---|
|
Surgical and medical procedures
death within 30 days
|
3.1%
2/64 • Number of events 2 • 30 days
|
Other adverse events
Adverse event data not reported
Additional Information
Program Director for PET Research
The Queen's Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place