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CompletedNCT00688038Updated Sep 15, 2017

Correlation of MR Thermal Imaging to Actual Size of Ablation During Laser Ablation Therapy

A Phase 4 interventional study of Laser Ablation and Magnetic Resonance Thermal Imaging in Advanced Cancer and Bone Metastases, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-15.

Sponsored by M.D. Anderson Cancer Center · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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).

Read the detailed description

Laser ablation is designed to destroy tumor tissue with the use of fiber optics that are placed directly into the tumor to deliver laser light energy into the tissue.

In this study, tumor destruction will be checked using MRTI. MRTI is very similar to other MRI techniques, but instead of providing imaging data, MRTI will provide temperature data for cancerous areas in the body during the laser ablation process. If tumor temperature can be measured more accurately, the laser ablation process may be safer.

Laser Ablation and the MRTI Scan:

If you are found to be eligible to take part in this study, on the day you have laser ablation, you will have an intravenous (IV) line placed. You will receive sedation or general anaesthesia (drugs to make you sleep) through a needle in your vein over 1-3 hours to lessen any pain you may have during the procedure. This process will be explained to you.

After receiving the anaesthesia, the following tests and procedures will be performed:

  • You will have a limited MRI.
  • Your skin will be cleaned and covered with sterile towels and sheets to lower the chance of an infection.
  • The doctor will use MRI scans to place a special needle (applicator) into the tumor. This applicator will be used to create heat at a high enough temperature that cells can be destroyed. Small masses may be destroyed in 1 treatment, but larger masses may require that the needle is placed several times. Each heating cycle takes less than 10 minutes.
  • During laser ablation, MRTI will be used to monitor the temperature within the ablation zone. The MRTI process is very similar to regular MRI.
  • Your heart rate and blood pressure will be measured during the entire procedure.
  • The entire procedure may take about 1-3 hours, depending on the size and location of your tumor.

After the procedure is completed, you will be kept in the hospital for 4-6 hours for observation. You will be checked for recovery from the sedation that you received during the procedure. Once you have recovered from the procedure, you will be allowed to leave the hospital. If you have side effects from the procedure, the doctor may decide to keep you in the hospital for a longer time period for observation.

Follow-Up Visits:

After you have completed the procedure, you will return to M. D. Anderson for follow-up visits. About one (1) week after the laser ablation, you will have a physical exam and an X-ray. About one (1) month after the laser ablation, you will have a physical exam and a limited MRI to check the status of the disease.

Length of Study:

You will be considered off-study after the 1-month follow up visit.

This is an investigational study. The laser ablation procedure is an FDA-approved procedure. The devices are commercially available and can be used outside research studies. The investigational part of this study involves using MRTI to check the effect of ablation on the tumor. Up to 24 participants will be enrolled in this study. All will be enrolled at M.D. Anderson.

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Conditions studied

  • Advanced Cancer
  • Bone Metastases

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Keywords

  • Advanced Cancer
  • Bone Metastases
  • Laser Ablation
  • Magnetic Resonance Thermal Imaging
  • Laser Induced Thermal Therapy
  • MRTI
  • LITT
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In context

Neoplasm Metastasis

3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.

This study's planned enrollment of 24 is below the median of 54 across 2,767 interventional studies indexed under Neoplasm Metastasis.

Browse Neoplasm Metastasis studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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 Eastern Cooperative Oncology Group 2 or better in adults
  6. Patient is able to undergo MRI
  7. Patients at least 18 years of age

Exclusion criteria

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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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Laser Ablation + MRTI

    Magnetic resonance thermal imaging = MRTI

    Procedure: Laser Ablation · Procedure: Magnetic Resonance Thermal Imaging

Interventions

  • ProcedureLaser Ablation

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

  • ProcedureMagnetic Resonance Thermal Imaging

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

    Also known as: MRTI

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What researchers measure

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.

    Time frame: 2 Years

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Study locations

1 site
  • University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00688038
Lead sponsor
M.D. Anderson Cancer Center
Collaborators
BioTex, Inc.
Responsible party
Sponsor
First posted
Jun 2, 2008
Start date
May 13, 2008
Primary completion
Sep 12, 2017
Completion
Sep 12, 2017
Last update
Sep 15, 2017

Study contacts

Kamran Ahrar, MD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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