Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122876
Status:
COMPLETED
Last Update Posted:
2007-12-07
First Post:
2005-07-19
Brief Title:
Tumor Ablation With Talaporfin Sodium and Interstitial Light Emitting Diodes Treating Hepatocellular Carcinoma HCC
Sponsor:
Light Sciences Oncology
Organization:
Light Sciences LLC
Study Overview
Official Title:
A Phase 12 Open-Label Study to Evaluate Safety and Preliminary Evidence of Effectiveness of Tumor Ablation With Talaporfin Sodium LS11 and Interstitial Light Emitting Diodes LEDs in the Treatment of Subjects With Inoperable Hepatocellular Carcinoma HCC
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether the Litx treatment is safe and effective in treating inoperable hepatocellular carcinoma HCC
Litx is an integrated treatment system comprising an intravenously administered photosensitizing agent Talaporfin Sodium LS11 that is activated by non-coherent light generated inside the tumor by an implanted light emitting diode LED array light source
Litx is an integrated treatment system comprising an intravenously administered photosensitizing agent Talaporfin Sodium LS11 that is activated by non-coherent light generated inside the tumor by an implanted light emitting diode LED array light source
Detailed Description:
Subjects that provide Informed Consent and satisfy the Eligibility Criteria will undergo CT or Ultrasound guided percutaneous placement of a single two three or four Light Sources depending on their tumor characteristics No more than four Light Sources will be used at a single treatment session The Light Sources may be used in a single lesion or in multiple lesions Depending on lesion size one or more Light Sources may be used to treat a single lesion
Following ultrasound or CT confirmation of the Light Sources patients will receive an intravenous dose of LS11 at 1 mgkg 15 minutes to 1 hour following completion of LS11 administration delivery of 200 Jcm light energy at 20 mWcm will begin Upon completion of light treatment the Light Sources will then be manually removed and the patients will be observed for acute complications
Subjects will be evaluated for treatment-related adverse events at every scheduled clinical visit Restaging by contrast enhanced spiral CT and tumor evaluation using the RECIST criteria are performed at Week 4 and Week 8
Subjects may receive a second Litx treatment at Week 4 or Week 8 as recommended by the study investigator Subjects who receive the second Litx treatment will be evaluated for treatment-related adverse events at every scheduled clinical visit Restaging by contrast enhanced spiral CT and tumor evaluation using the RECIST criteria are performed The active phase of the protocol ends 8 weeks after the last treatment received
Following completion of the active phase of the protocol subjects will be monitored for survival for one year at 6 9 and 12 month time points from the date of study entry or until death whichever occurs first
Following ultrasound or CT confirmation of the Light Sources patients will receive an intravenous dose of LS11 at 1 mgkg 15 minutes to 1 hour following completion of LS11 administration delivery of 200 Jcm light energy at 20 mWcm will begin Upon completion of light treatment the Light Sources will then be manually removed and the patients will be observed for acute complications
Subjects will be evaluated for treatment-related adverse events at every scheduled clinical visit Restaging by contrast enhanced spiral CT and tumor evaluation using the RECIST criteria are performed at Week 4 and Week 8
Subjects may receive a second Litx treatment at Week 4 or Week 8 as recommended by the study investigator Subjects who receive the second Litx treatment will be evaluated for treatment-related adverse events at every scheduled clinical visit Restaging by contrast enhanced spiral CT and tumor evaluation using the RECIST criteria are performed The active phase of the protocol ends 8 weeks after the last treatment received
Following completion of the active phase of the protocol subjects will be monitored for survival for one year at 6 9 and 12 month time points from the date of study entry or until death whichever occurs first
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