PET/CT in Diagnosing Patients With Liver Cancer Undergoing Surgical Resection

NCT01395030 | Completed Phase 2 Results DMC

• 4 other identifiers: RA-2011-025NCI-2012-02095CHS-19373R01CA161209
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial studies positron emission tomography (PET)/computed tomography (CT) in diagnosing patients with liver cancer undergoing surgical resection. Diagnostic procedures, such as fluorine-18 fluoromethylcholine PET/CT, may help find and diagnose liver cancer.

Conditions

Adult Hepatocellular Carcinoma; Localized Resectable Adult Liver Carcinoma

Outcome Measures

Primary Outcomes (5)

• Fluorine-18 (18F) Fluoromethylcholine (FCH) PET/CT Parameters for Assessing Hepatocellular Carcinoma (HCC): Area Under the Receiver Operating Characteristic Curve.

  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).

  Up to study completion at an average of 2.5 years

• Fluorine-18 (18F) Fluoromethylcholine (FCH) PET/CT Parameters for Assessing Hepatocellular Carcinoma (HCC): Sensitivity/Specificity

  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.

  Up to study completion at an average of 2.5 years

• Statistical Significance of Molecular Pathways Associated With Choline Metabolism as Identified Through Gene Set Enrichment Analysis of Hepatocellular Carcinoma (HCC) Tumor Samples.

  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).

  Up to study completion at an average of 2.5 years

• Clinical Liver Disease Severity Based on Liver Fibrosis (Metavir) Stage

  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.

  Up to 1 year

• Number of Participants Comprising Two Distinct PET/CT Imaging Phenotypes (High FCH Uptake vs. Low FCH Uptake) Between the Different Tumor Sub-classes

  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.

  Up to study completion at an average of 2.5 years

Study Arms (1)

18F-fluoromethylcholine PET/CT

EXPERIMENTAL

Patients undergo 18F-fluoromethylcholine positron emission tomography (PET)/ computed tomography (CT) scan within 14 days of surgical resection of liver tumor.

Diagnostic Test: Computed Tomography; Drug: 18F-fluoromethylcholine; Diagnostic Test: Positron Emission Tomography

Interventions

Computed Tomography DIAGNOSTIC_TEST

Undergo FCH PET/CT

Also known as: Computerized Axial Tomography, computerized tomography, CT, CT scan, tomography

18F-fluoromethylcholine PET/CT

18F-fluoromethylcholine DRUG

Undergo FCH PET/CT

Also known as: fluorine-18 fluoromethylcholine, 18F-fluorocholine, 18F-choline, FCH

18F-fluoromethylcholine PET/CT

Positron Emission Tomography DIAGNOSTIC_TEST

Undergo FCH PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

18F-fluoromethylcholine PET/CT

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Liver tumor diagnosed histologically as HCC or suspected of being HCC in association with serum alpha-fetoprotein level \> 200 or tumor mass with characteristics of malignancy on diagnostic imaging
• Under the care of a surgical attending
• Deemed a surgical candidate and has agreed to surgery to remove a portion of the liver containing tumor
• Child-Pugh A/B

You may not qualify if:

• Weight \> 350 lbs
• Pregnant or lactating female, a serum pregnancy test will be performed within 2 weeks or less before the date of the FCH PET/CT scan in all women capable of becoming pregnant
• Serious underlying medical condition that would impair patient's ability to tolerate the imaging procedure
• Concurrent treatment with chemotherapy, molecule-selective, biological, or radiotherapeutic agent

Sponsors & Collaborators

• Queen's Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States

Location

Related Publications (1)

• Kwee SA, Wong L, Chan OTM, Kalathil S, Tsai N. PET/CT with 18F Fluorocholine as an Imaging Biomarker for Chronic Liver Disease: A Preliminary Radiopathologic Correspondence Study in Patients with Liver Cancer. Radiology. 2018 Apr;287(1):294-302. doi: 10.1148/radiol.2018171333. Epub 2018 Jan 9.

  PMID: 29315063 RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Tomography, X-Ray Computed; Tomography; fluoromethylcholine; fluorocholine; Positron-Emission Tomography

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography, Emission-Computed; Radionuclide Imaging; Diagnostic Techniques, Radioisotope

Results Point of Contact

• Title: Program Director for PET Research
• Organization: The Queen's Medical Center

skwee@queens.org

808-691-5466

Study Officials

• Sandi Kwee, MD

  Queen's Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 12, 2011
• First Posted: July 15, 2011
• Study Start: August 15, 2011
• Primary Completion: May 31, 2017
• Study Completion: May 31, 2018
• Last Updated: September 26, 2018
• Results First Posted: September 26, 2018

Record last verified: 2018-08

Locations

US (1)