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Study Summary
No. 2007-0393:.......Advanced Cancers; Bladder; Bone; Breast; Colorectal; Genitourinary; Lung; Myeloma; Unknown Primary......Kamran Ahrar......Interventional Radiology
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Study Summary Title
Study Summary
Number:		2007-0393
Study Title:A study to determine correlation of MR thermal imaging to actual size of ablation during laser therapy of metastases to bone
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Physician New Patient Referral
Name:Kamran AhrarPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Interventional RadiologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-4795
Contact us about clinical trials
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General Information
Disease Group:Advanced Cancers
Bladder
Bone
Breast
Colorectal
Genitourinary
Lung
Myeloma
Unknown Primary		Supported By:BioTex, Inc.
Phase of Study:N/AReturn
Visit:		Standard of care for percutaneous thermal ablation (RFA or laser):
Follow up visits at Interventional Radiology clinic at 1 week and 1 month
Treatment
Agents:		Laser AblationHome Care:N/A
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:		Patients will be discharged home on the same day after treatment unless other
medical needs warrant admission to the hospital.
Description/
Intervention:		The goal of this clinical research study is to learn how well magnetic
resonance thermal imaging (MRTI) can check the amount of tumor being destroyed
using a therapy called laser ablation (a procedure that uses lasers to create
heat that is designed to destroy cancer cells).
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Study Objectives / Outcomes
During Laser Induced Thermal Therapy (LITT) of soft tissue metastases in bone, we will collect and analyze magnetic resonance thermal imaging (MRTI) data to determine the correlation between observed temperatures determined from MRTI and the actual size of ablation as determined by post-ablation contrast-enhanced magnetic resonance imaging (MRI).
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Study Status Information
Study Activation / Registration Date:05/13/2008
IRB Review and Approval Date:05/13/2008
Study Type:Other
Recruitment Status:Open
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Patients with tumor metastases to the skeleton who are referred to interventional radiology for percutaneous ablation

2) Surgery is not a viable or desirable alternative therapy at the time of enrollment

3) Radiation therapy has failed or not indicated or can be safely postponed

4) Symptomatic or asymptomatic tumor size less than or equal to 3 cm in its largest diameter.

5) Performance status is ECOG 2 or better in adults

6) Patient is able to undergo MRI

7) Patients at least 18 years of age
Exclusion Criteria:1) Patients with uncorrectable coagulopathy

2) Patients with pacemaker or defibrillator

3) Patients with metallic prosthesis at the site of the intended ablation

4) Patients with spinal cord compression or epidural tumor extension

5) Patients with vertebral body metastases exhibiting posterior wall destruction

6) Patients with any soft tissue extension of a vertebral tumor

7) Patients with any metastasis that is extrinsically located in vertebra or any long bones of the extremities compromising the cortex

8) Patients with tumors having direct extension or involvement of a joint capsule or a major nerve

9) Patients with Neutropenia (ANC less then 1000) or known active infection

10) Patients unable to undergo conscious sedation

11) Children under 18 years of age will be excluded from this study
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Links
Registration Number: NCT00688038
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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