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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
NA
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05095519