Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00247260
Status:
UNKNOWN
Last Update Posted:
2007-03-15
First Post:
2005-10-31
Brief Title:
Safety of 32P BioSilicon in Patients With Hepatocellular Carcinoma
Sponsor:
pSiVida Limited
Organization:
pSiVida Limited
Study Overview
Official Title:
A Study of the Safety Profile of Three Escalating Radioactivity Levels of 32P BioSilicon Delivered With the SIMPL Needle as Intratumoural Implantations in Patients With Unresectable Hepatocellular Carcinoma
Status:
UNKNOWN
Status Verified Date:
2005-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Brachytherapy is a recent technique used in the treatment of tumours and involves the use of radioactive sources brought into close contact with the target tissues One of the principal benefits of brachytherapy is that high radiation doses can be localised within the tumour with the consequence of minimal side effects 32P is a radionuclide ideal for brachytherapy as it has high energy beta emitting properties typically a maximum tissue range of about 8 mm and a half life of 143 days 32P BioSiliconTM is an active implantable medical device encapsulating 32P within the internal microcrystalline structure of highly pure inert silicon and acts as a sealed source for the provision of 32 phosphorous
Tumours targeted with 32P BioSiliconTM are hypothesized to show a reduction in volume with a low incidence of side effects associated with the treatment Prolongation of survival and improved quality of life would be favourable outcomes of the investigational product
Tumours targeted with 32P BioSiliconTM are hypothesized to show a reduction in volume with a low incidence of side effects associated with the treatment Prolongation of survival and improved quality of life would be favourable outcomes of the investigational product
Detailed Description:
The study will enroll between 48 to 50 patients from all sites Patients will be enrolled sequentially into the three groups starting wth Group 1 which will investigate the lower radioactivity level and then progress to a higher radioactivity level in Group 2 and then Group 3 The approval to enrol patients into the next group will be assessed and determined by a Data Monitoring Board All patients will be followed up to 52 weeks from the start date of primary implantations
Patients will receive intratumoural implantations of 32P BioSiliconTM under imaging guidance and local anaesthesia by designated interventional radiologists using the SIMPL needle or conventional needles depending on the size and location of the tumour as assessed by the designated interventional radiologists There are only a designated number of sites that will perform the implantation procedure although there are multiple sites recruiting and following up with patients
Tumour assessment tumour calculation and measurement will be performed by an independent radiologist CT scans from all participating sites will be sent in DICOM format to the designated radiologist for assessment
Safety assessment and grading of CTCAE will be performed by the same investigator for that same patient throughout the entire study period There will be an interim analysis when all patients complete 24 weeks evaluating the safety profile and target tumour response of the patients
32P BioSiliconTM will be prepared by designated personnel licensed to handle radioactive products and all radioactive waste will be handed and managed as per the institutions guidelines and in compliance with local regulatory requirements
Patients will receive intratumoural implantations of 32P BioSiliconTM under imaging guidance and local anaesthesia by designated interventional radiologists using the SIMPL needle or conventional needles depending on the size and location of the tumour as assessed by the designated interventional radiologists There are only a designated number of sites that will perform the implantation procedure although there are multiple sites recruiting and following up with patients
Tumour assessment tumour calculation and measurement will be performed by an independent radiologist CT scans from all participating sites will be sent in DICOM format to the designated radiologist for assessment
Safety assessment and grading of CTCAE will be performed by the same investigator for that same patient throughout the entire study period There will be an interim analysis when all patients complete 24 weeks evaluating the safety profile and target tumour response of the patients
32P BioSiliconTM will be prepared by designated personnel licensed to handle radioactive products and all radioactive waste will be handed and managed as per the institutions guidelines and in compliance with local regulatory requirements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None