Advanced CancerPhase 4NCT00688038
Correlation of MR Thermal Imaging to Actual Size of Ablation During Laser Ablation Therapy
A Phase 4 study testing Laser Ablation and Magnetic Resonance Thermal Imaging in people with Advanced Cancer and Bone Metastases, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Bone Metastases
- What is being tested?
- Laser Ablation and Magnetic Resonance Thermal Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2008to 12 Sep 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Study to Determine Correlation of MR Thermal Imaging to Actual Size of Ablation During Laser Therapy of Metastases to Bone
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.
- Conditions
- Advanced Cancer, Bone Metastases
- Being tested
- Laser Ablation, Magnetic Resonance Thermal Imaging
- Keywords
- Advanced Cancer, Bone Metastases, Laser Ablation, Magnetic Resonance Thermal Imaging, Laser Induced Thermal Therapy, MRTI, LITT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser AblationProcedure or surgery
Laser ablation procedure taking about 1-3 hours, depending on the size and location of the tumor.
Magnetic Resonance Thermal ImagingProcedure or surgery
Also called MRTI
MRTI will be used to monitor the temperature within the ablation zone during the laser ablation.
| Study group | Role | What they receive |
|---|---|---|
| Laser Ablation + MRTI | Experimental | Magnetic resonance thermal imaging = MRTI Receives: Procedure: Laser Ablation; Procedure: Magnetic Resonance Thermal Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2008 (estimated)
- Study start13 May 2008
- Primary completion12 Sep 2017
- Study completion12 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- BioTex, Inc.
- Responsible party
- Sponsor
- Investigators
- Kamran Ahrar, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00688038
- Sponsor's protocol ID
- 2007-0393
- Other IDs
- NCI-2011-00518
- Status last verified
- Sep 2017
- First submitted
- 28 May 2008
- Last updated
- 15 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine Correlation of MR Thermal Imaging to Actual Size of Ablation During Laser Therapy of Metastases to Bone
- ClinicalTrials.gov ID
- NCT00688038
- Acronym / sponsor ID
- 2007-0393
- Conditions
- Advanced Cancer, Bone Metastases
- Keywords
- Advanced Cancer, Bone Metastases, Laser Ablation, Magnetic Resonance Thermal Imaging, Laser Induced Thermal Therapy, MRTI, LITT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- BioTex, Inc.
- Study start
- 13 May 2008 (actual)
- Primary completion
- 12 Sep 2017 (actual)
- Study completion
- 12 Sep 2017 (actual)
- First posted
- 2 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser Ablation + MRTI | Experimental | Procedure: Laser Ablation, Procedure: Magnetic Resonance Thermal ImagingMagnetic resonance thermal imaging = MRTI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser AblationLaser ablation procedure taking about 1-3 hours, depending on the size and location of the tumor. | Procedure or surgery | Laser Ablation + MRTI |
| Magnetic Resonance Thermal ImagingAlso: MRTIMRTI will be used to monitor the temperature within the ablation zone during the laser ablation. | Procedure or surgery | Laser Ablation + MRTI |
Primary outcome
Correlation of Maximal Dimensions of 60-degree Celsius Isotherm + Ablation Zone Dimensions as determined by MRI
Time frame: 2 Years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamran Ahrar, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Laser Ablation and Magnetic Resonance Thermal Imaging in people with Advanced Cancer and Bone Metastases, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of Maximal Dimensions of 60-degree Celsius Isotherm + Ablation Zone Dimensions as determined by MRI (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2017.