Back to resultsHepatocellular Carcinoma Imaging Using PSMA PET/CT (HepaSMART)
Primary Purpose
Hepatocellular Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
18F-DCFPyL
Sponsored by
About this trial
This is an interventional diagnostic trial for Hepatocellular Carcinoma focused on measuring Hepatocellular carcinoma, PSMA, 18F-DCFPyL
Eligibility Criteria
Inclusion Criteria:
- Male or female aged 18 years or older at screening
- Has provided written informed consent for participation in the study
- Must have risk factors for HCC e.g. cirrhosis, chronic hepatitis B infection with or without cirrhosis
- Patients with liver lesions ≥1 cm suspicious for HCC but with indeterminate features on CT and MRI meeting LI-RADS 3 or 4 criteria planned for biopsy, OR patients with liver lesions diagnostic of HCC based on CT or MRI meeting LI-RADS 5 criteria planned for surgical resection
- Patients must be willing and able to comply with the protocol and procedures for the duration of the study
- Patients must be available for follow-up
Exclusion Criteria:
- Abdominal surgery or radiotherapy to the abdomen within <4 weeks of registration. Patients must have recovered from any effects of any major surgery
- Uncontrolled intercurrent illness that is likely to impede participation and or compliance
- Any history of prostate cancer or elevated PSA level for male patients
- Other malignancies unless curatively treated with no evidence of disease within previous 3-years other than adequately treated non-melanoma skin cancer or melanoma in situ
- Participation in another clinical study with an investigational product or another systemic cancer therapy administered in the last 4 weeks
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with requirements of the study
- Women who are pregnant or lactating
- Cirrhosis due to congenital hepatic fibrosis, vascular disorders (e.g. Budd-Chiari syndrome) or cardiac cirrhosis
Sites / Locations
- St Vincent's HospitalRecruiting
- Austin HealthRecruiting
- Peter MacCallum Cancer CentreRecruiting
- The Royal Melbourne HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
18F-DCFPyL
Arm Description
Patients will undergo PET/CT imaging following intravenous administration of 18F-DCFPyL
Outcomes
Primary Outcome Measures
True Positive Rate per patient
The probability that HCC is present when the PSMA-PET/CT test result is positive on a per patient basis.
True Negative Rate per patient
The probability that HCC is absent when the PSMA-PET/CT test result is negative on a per patient basis.
True Positive Rate per lesion
The probability that HCC is present when the PSMA-PET/CT test result is positive on a per lesion basis.
True Negative Rate per lesion.
The probability that HCC is absent when the PSMA-PET/CT test result is negative on a per lesion basis.
Secondary Outcome Measures
PSMA uptake
Qualitative uptake of PSMA measured on a per lesion basis.
Maximum standard uptake value
Maximum standard uptake value of lesions on PSMA PET/CT.
CT LIRADS (Liver Imaging Reporting and Data System) Score
LI RADS Score for CT lesions.
PSMA expression.
Expression of PSMA per lesion.
GLUT-1 expression
Expression of GLUT 1 per lesion.
Full Information
NCT ID
NCT05095519
First Posted
September 21, 2021
Last Updated
May 17, 2022
Sponsor
Peter MacCallum Cancer Centre, Australia
1. Study Identification
Unique Protocol Identification Number
NCT05095519
Brief Title
Hepatocellular Carcinoma Imaging Using PSMA PET/CT
Acronym
HepaSMART
Official Title
Hepatocellular Carcinoma Imaging Using PSMA PET/CT - a Prospective Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 8, 2021 (Actual)
Primary Completion Date
March 8, 2023 (Anticipated)
Study Completion Date
September 8, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peter MacCallum Cancer Centre, Australia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the research is to evaluate the use of a PSMA PET/CT (Prostate Specific Membrane Antigen Positron Emission Tomography/Computerized Tomography) scan in the diagnosis of HCC (hepatocellular carcinoma) and comparing it to standard scanning techniques with CT (Computed Tomography) or MRI (Magnetic Resonance Imaging).
Detailed Description
A total of 30 patients will be recruited in this prospective pilot study who have HCC on imaging criteria (LI-RADS 5) for surgical resection, or patients with indeterminate liver lesions (LI-RADS 3 or 4) planned for liver biopsy. 18F-DCFPYL PSMA PET/CT will be performed prior to the planned surgery or liver biopsy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatocellular carcinoma, PSMA, 18F-DCFPyL
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
18F-DCFPyL
Arm Type
Experimental
Arm Description
Patients will undergo PET/CT imaging following intravenous administration of 18F-DCFPyL
Intervention Type
Drug
Intervention Name(s)
18F-DCFPyL
Intervention Description
18F-DCFPyL will be administered with a single dose of 3.5 MBq per kg (2-4 MBq per kg), maximum 400 MBq), administered as a slow (over 30 seconds) intravenous injection
Primary Outcome Measure Information:
Title
True Positive Rate per patient
Description
The probability that HCC is present when the PSMA-PET/CT test result is positive on a per patient basis.
Time Frame
6 months
Title
True Negative Rate per patient
Description
The probability that HCC is absent when the PSMA-PET/CT test result is negative on a per patient basis.
Time Frame
6 months
Title
True Positive Rate per lesion
Description
The probability that HCC is present when the PSMA-PET/CT test result is positive on a per lesion basis.
Time Frame
6 months
Title
True Negative Rate per lesion.
Description
The probability that HCC is absent when the PSMA-PET/CT test result is negative on a per lesion basis.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
PSMA uptake
Description
Qualitative uptake of PSMA measured on a per lesion basis.
Time Frame
6 months
Title
Maximum standard uptake value
Description
Maximum standard uptake value of lesions on PSMA PET/CT.
Time Frame
6 months
Title
CT LIRADS (Liver Imaging Reporting and Data System) Score
Description
LI RADS Score for CT lesions.
Time Frame
6 months
Title
PSMA expression.
Description
Expression of PSMA per lesion.
Time Frame
6 months
Title
GLUT-1 expression
Description
Expression of GLUT 1 per lesion.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female aged 18 years or older at screening
Has provided written informed consent for participation in the study
Must have risk factors for HCC e.g. cirrhosis, chronic hepatitis B infection with or without cirrhosis
Patients with liver lesions ≥1 cm suspicious for HCC but with indeterminate features on CT and MRI meeting LI-RADS 3 or 4 criteria planned for biopsy, OR patients with liver lesions diagnostic of HCC based on CT or MRI meeting LI-RADS 5 criteria planned for surgical resection
Patients must be willing and able to comply with the protocol and procedures for the duration of the study
Patients must be available for follow-up
Exclusion Criteria:
Abdominal surgery or radiotherapy to the abdomen within <4 weeks of registration. Patients must have recovered from any effects of any major surgery
Uncontrolled intercurrent illness that is likely to impede participation and or compliance
Any history of prostate cancer or elevated PSA level for male patients
Other malignancies unless curatively treated with no evidence of disease within previous 3-years other than adequately treated non-melanoma skin cancer or melanoma in situ
Participation in another clinical study with an investigational product or another systemic cancer therapy administered in the last 4 weeks
Has known psychiatric or substance abuse disorders that would interfere with cooperation with requirements of the study
Women who are pregnant or lactating
Cirrhosis due to congenital hepatic fibrosis, vascular disorders (e.g. Budd-Chiari syndrome) or cardiac cirrhosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Grace Kong
Phone
+61 3 85595000
Email
NMResearch@petermac.org
First Name & Middle Initial & Last Name or Official Title & Degree
Research Manager
Phone
+61 3 8559 6602
Facility Information:
Facility Name
St Vincent's Hospital
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kim Taubman,, MD
Facility Name
Austin Health
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sze Ting Lee, MD
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Kong, MD
Facility Name
The Royal Melbourne Hospital
City
Melbourne
State/Province
Victoria
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siddharth Sood, MD
12. IPD Sharing Statement
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Hepatocellular Carcinoma Imaging Using PSMA PET/CT
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