MRI-Guided Laser Induced Thermal Therapy

NCT01515085 | Terminated

• 1 other identifier: 0220110114
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Does MR-guided laser interstitial thermal therapy (MRgLITT) prior to chemotherapy and/or radiation give patients a beneficial increase in overall survival? Laser induced thermal therapy (LITT) is a minimally invasive procedure for destroying tissue through generation of heat.

Conditions

Malignant Glioma

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  three years

Secondary Outcomes (1)

• Overall survival

  three years

Study Arms (1)

biopsy proven glioma, no prior treatment

Procedure: laser interstitial thermal therapy

Interventions

laser interstitial thermal therapy PROCEDURE

residual gliomas either after debulking or biopsy evaluated for intervention with laser ablation prior to onset of adjuvant therapy

Also known as: laser ablation, LITT

biopsy proven glioma, no prior treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with brain tumors receiving MR-guided laser ablation

You may qualify if:

• Subjects that have/will undergo MRgLITT for inoperable brain tumor.
• Tumor size \< 3cm in transverse diameter for each planned applicator placement.
• Tumor size \< 4 cm in largest dimension.
• Lesion(s) are clearly defined on pre-therapy contrast enhanced MRI scans as determined by the treating surgeon.
• Karnofsky Performance Scale score \> 70.
• ECOG performance status of 2 or better.
• Biopsy proven histologic diagnosis of malignant glioma.

You may not qualify if:

• Patients with co-existing medical conditions with life expectancy \< 1 year.
• Patients having received pre-ablation chemotherapy and/or radiation to lesion.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Rutgers Cancer Institute of New Jersey: collaborator

Study Sites (1)

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Glioma

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Shabbar F Danish, MD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2011
• First Posted: January 23, 2012
• Study Start: August 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: May 22, 2014

Record last verified: 2014-05

Locations

US (1)