MR-Guided Laser Ablation of Hepatic Tumors | NCT01630239

Studies
MR-Guided Laser Ablation of Hepatic Tumors

NCT01630239

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

May 5, 2015Estimated

Enrollment

1Actual

Phase

Early Phase 1

Conditions

Soft Tissue Tumors

Interventions

Laser ablation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Mar 2015Actual

Completion Date

Mar 2015Actual

First Submitted Date

Jun 22, 2012

First Submission Date that Met QC Criteria

Jun 26, 2012

First Posted Date

Jun 28, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 1, 2015

Last Update Posted Date

May 5, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a pilot study to investigate the performance of MR-guided Laser Induced Thermal Therapy (LITT) in the treatment of liver tumors.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Visualise Thermal Therapy System	Experimental		Procedure: Laser ablation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laser ablation	Procedure	Laser ablation of hepatic tumors	Visualise Thermal Therapy System

Measure	Description	Time Frame
MR Images		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with soft tissue tumor metastases to the liver who are referred to Interventional Radiology for treatment.
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
Tumor size ≤ 5 cm at its largest diameter
Tumor position is not in the central liver hilum
Performance status is ECOG 2 or better in adults
Patient is able to undergo MRI

Exclusion Criteria:

Patients with pacemaker or defibrillator
Patients with metallic surgical clips close to the site of the intended ablation
Pregnant women
Patients with hilar liver lesions

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Woodrum, MD, PhD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Rochester	Minnesota	55905	United States

Condition Browse Module

MeSH Terms

ID	Term
D012983	Soft Tissue Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D053685	Laser Therapy

Ancestor Terms

ID	Term
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided