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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05095519




Registration number
NCT05095519
Ethics application status
Date submitted
21/09/2021
Date registered
27/10/2021
Date last updated
18/03/2024

Titles & IDs
Public title
Hepatocellular Carcinoma Imaging Using PSMA PET/CT
Scientific title
Hepatocellular Carcinoma Imaging Using PSMA PET/CT - a Prospective Pilot Trial
Secondary ID [1] 0 0
HREC/62461/PMCC
Universal Trial Number (UTN)
Trial acronym
HepaSMART
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatocellular Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 18F-DCFPyL

Experimental: 18F-DCFPyL - Patients will undergo PET/CT imaging following intravenous administration of 18F-DCFPyL


Treatment: Drugs: 18F-DCFPyL
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
True Positive Rate per patient
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
True Negative Rate per patient
Timepoint [2] 0 0
6 months
Primary outcome [3] 0 0
True Positive Rate per lesion
Timepoint [3] 0 0
6 months
Primary outcome [4] 0 0
True Negative Rate per lesion.
Timepoint [4] 0 0
6 months
Secondary outcome [1] 0 0
PSMA uptake
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Maximum standard uptake value
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
CT LIRADS (Liver Imaging Reporting and Data System) Score
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
PSMA expression.
Timepoint [4] 0 0
6 months
Secondary outcome [5] 0 0
GLUT-1 expression
Timepoint [5] 0 0
6 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
8/09/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St Vincent's Hospital - Fitzroy
Recruitment hospital [2] 0 0
Austin Health - Heidelberg
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [4] 0 0
The Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment postcode(s) [4] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Peter MacCallum Cancer Centre, Australia
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05095519
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Grace Kong
Address 0 0
Country 0 0
Phone 0 0
+61 3 85595000
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05095519