NCT00688038

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 13, 2008

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 2, 2008

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 12, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 12, 2017

Completed
Last Updated

September 15, 2017

Status Verified

September 1, 2017

Enrollment Period

9.3 years

First QC Date

May 28, 2008

Last Update Submit

September 14, 2017

Conditions

Advanced CancerBone Metastases

Keywords

Advanced CancerBone MetastasesLaser AblationMagnetic Resonance Thermal ImagingLaser Induced Thermal TherapyMRTILITT

Outcome Measures

Primary Outcomes (1)

  • Correlation of Maximal Dimensions of 60-degree Celsius Isotherm + Ablation Zone Dimensions as determined by MRI

    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) during Laser Induced Thermal Therapy (LITT) of soft tissue metastases in bone.

    2 Years

Study Arms (1)

Laser Ablation + MRTI

EXPERIMENTAL

Magnetic resonance thermal imaging = MRTI

Procedure: Laser AblationProcedure: Magnetic Resonance Thermal Imaging

Interventions

Laser AblationPROCEDURE

Laser ablation procedure taking about 1-3 hours, depending on the size and location of the tumor.

Laser Ablation + MRTI
Magnetic Resonance Thermal ImagingPROCEDURE

MRTI will be used to monitor the temperature within the ablation zone during the laser ablation.

Also known as: MRTI
Laser Ablation + MRTI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with tumor metastases to the skeleton who are referred to interventional radiology for percutaneous ablation
  • Surgery is not a viable or desirable alternative therapy at the time of enrollment
  • Radiation therapy has failed or not indicated or can be safely postponed
  • Symptomatic or asymptomatic tumor size less than or equal to 3 cm in its largest diameter.
  • Performance status is Eastern Cooperative Oncology Group 2 or better in adults
  • Patient is able to undergo MRI
  • Patients at least 18 years of age

You may not qualify if:

  • Patients with uncorrectable coagulopathy
  • Patients with pacemaker or defibrillator
  • Patients with metallic prosthesis at the site of the intended ablation
  • Patients with spinal cord compression or epidural tumor extension
  • Patients with vertebral body metastases exhibiting posterior wall destruction
  • Patients with any soft tissue extension of a vertebral tumor
  • Patients with any metastasis that is extrinsically located in vertebra or any long bones of the extremities compromising the cortex
  • Patients with tumors having direct extension or involvement of a joint capsule or a major nerve
  • Patients with Neutropenia (ANC less then 1000) or known active infection
  • Patients unable to undergo conscious sedation
  • Children under 18 years of age will be excluded from this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Interventions

Laser Therapy

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Kamran Ahrar, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2008

First Posted

June 2, 2008

Study Start

May 13, 2008

Primary Completion

September 12, 2017

Study Completion

September 12, 2017

Last Updated

September 15, 2017

Record last verified: 2017-09

Locations

US(1)