Last updated: March 14, 2024
Sponsor: Peter MacCallum Cancer Centre, Australia
Overall Status: Active - Recruiting
Phase
2
Condition
Liver Cancer
Cancer/tumors
Digestive System Neoplasms
Treatment
18F-DCFPyL
Clinical Study ID
NCT05095519
HREC/62461/PMCC
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 orwithout cirrhosis
- Patients with liver lesions ≥1 cm suspicious for HCC but with indeterminate featureson CT and MRI meeting LI-RADS 3 or 4 criteria planned for biopsy, OR patients withliver lesions diagnostic of HCC based on CT or MRI meeting LI-RADS 5 criteria plannedfor surgical resection
- Patients must be willing and able to comply with the protocol and procedures for theduration of the study
- Patients must be available for follow-up
Exclusion
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 orcompliance
- Any history of prostate cancer or elevated PSA level for male patients
- Other malignancies unless curatively treated with no evidence of disease withinprevious 3-years other than adequately treated non-melanoma skin cancer or melanoma insitu
- Participation in another clinical study with an investigational product or anothersystemic cancer therapy administered in the last 4 weeks
- Has known psychiatric or substance abuse disorders that would interfere withcooperation with requirements of the study
- Women who are pregnant or lactating
- Cirrhosis due to congenital hepatic fibrosis, vascular disorders (e.g. Budd-Chiarisyndrome) or cardiac cirrhosis
Study Design
Total Participants: 30
Treatment Group(s): 1
Primary Treatment: 18F-DCFPyL
Phase: 2
Study Start date:
September 08, 2021
Estimated Completion Date:
September 08, 2024
Study Description
Connect with a study center
St Vincent's Hospital
Fitzroy, Victoria 3065
AustraliaActive - Recruiting
Austin Health
Heidelberg, Victoria 3084
AustraliaActive - Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
AustraliaActive - Recruiting
The Royal Melbourne Hospital
Melbourne, Victoria
AustraliaActive - Recruiting
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