NCT00207350

Brief Summary

The researchers' specific aims are to test the following hypotheses: Hypothesis 1: A tumor can be completely ablated by ILT with MRI-guidance. Hypothesis 2: The MRI-based 3D temperature map of tissue during ILT is predictive of destruction. Hypothesis 3: The 3D "thermal dose" map that is based on the tissue's temperature over time is more predictive of tissue destruction than the temperature map.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2002

Longer than P75 for not_applicable

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

January 1, 2002

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

4.9 years

First QC Date

September 12, 2005

Last Update Submit

February 17, 2017

Conditions

Brain Tumor

Keywords

Brain Tumor

Outcome Measures

Primary Outcomes (1)

  • Ablation of lesion

    During procedure

Secondary Outcomes (1)

  • Patients undergoing ILT will be assessed pre- and post-operatively based on a neurological exam by a physician and patient self-assessment using the Glioma Outcomes Questionnaire

    3 Months

Study Arms (1)

Brain tumor

OTHER

Neurosurgical use of Interstitial Laser therapy

Device: Interstitial Laser Therapy

Interventions

Interstitial Laser TherapyDEVICE

Device

Also known as: ILT
Brain tumor

Eligibility Criteria

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

You may qualify if:

  • Male or female
  • Age 18+
  • Surgically difficult to access tumors including intracerebral metastases

You may not qualify if:

  • Patients unwilling or unable to give written consent
  • Patients at risk for cardiac ischemia
  • Patients who cannot physically fit in the MRI scanner in the MRI OR
  • Patients with contraindications to MRI imaging such as pacemakers, non-compatible aneurysm clips, shrapnel, and other internal ferromagnetic objects
  • Patients with coagulopathies, severe medical problems, cardiac arrhythmias or abnormal BUN

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham & Women's Hospital

Boston, Massachusetts, 02155, United States

Location

Related Publications (7)

  • Schulze PC, Vitzthum HE, Goldammer A, Schneider JP, Schober R. Laser-induced thermotherapy of neoplastic lesions in the brain--underlying tissue alterations, MRI-monitoring and clinical applicability. Acta Neurochir (Wien). 2004 Aug;146(8):803-12. doi: 10.1007/s00701-004-0293-5. Epub 2004 Jun 7.

    PMID: 15254802BACKGROUND

  • Peller M, Muacevic A, Reinl H, Sroka R, Abdel-Rahman S, Issels R, Reiser MF. [MRI-assisted thermometry for regional hyperthermia and interstitial laser thermotherapy]. Radiologe. 2004 Apr;44(4):310-9. doi: 10.1007/s00117-004-1032-x. German.

    PMID: 15057421BACKGROUND

  • McNichols RJ, Gowda A, Kangasniemi M, Bankson JA, Price RE, Hazle JD. MR thermometry-based feedback control of laser interstitial thermal therapy at 980 nm. Lasers Surg Med. 2004;34(1):48-55. doi: 10.1002/lsm.10243.

    PMID: 14755424BACKGROUND

  • Leonardi MA, Lumenta CB. Stereotactic guided laser-induced interstitial thermotherapy (SLITT) in gliomas with intraoperative morphologic monitoring in an open MR: clinical expierence. Minim Invasive Neurosurg. 2002 Dec;45(4):201-7. doi: 10.1055/s-2002-36203.

    PMID: 12494354BACKGROUND

  • Kuroda K, Kettenbach J, Nabavi A, Silverman SG, Morrison PR, Jolesz FA. Clinical trials of MR thermography for laser ablation of brain tumors. Journal of the Japanese Society for Magnetic Resonance in Medicine (JMRM) 2002; 21;7,8:298-306.

    BACKGROUND

  • Straube T, Kahn T. Thermal therapies in interventional MR imaging. Laser. Neuroimaging Clin N Am. 2001 Nov;11(4):749-57.

    PMID: 11995429BACKGROUND

  • Muacevic A, Peller M, Sroka R, Kalusche B, Pongratz T, Kreth FW, Steiger HJ, Reiser M, Reulen HJ. [Brain protective interstitial laser thermotherapy. Therapy of brain tumors without secondary damage]. MMW Fortschr Med. 2001 May 28;143 Suppl 2:87-8. German.

    PMID: 11434269BACKGROUND

Related Links

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Golby Alexandra, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 21, 2005

Study Start

January 1, 2002

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

US(1)