NCT01630239

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Jun 2012

Typical duration for early_phase_1

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

June 1, 2012

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 28, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

May 5, 2015

Status Verified

May 1, 2015

Enrollment Period

2.7 years

First QC Date

June 22, 2012

Last Update Submit

May 1, 2015

Conditions

Soft Tissue Tumors

Outcome Measures

Primary Outcomes (1)

  • MR Images

    6 months

Study Arms (1)

Visualise Thermal Therapy System

EXPERIMENTAL
Procedure: Laser ablation

Interventions

Laser ablationPROCEDURE

Laser ablation of hepatic tumors

Visualise Thermal Therapy System

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Soft Tissue Neoplasms

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • David Woodrum, MD, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Radiology

Study Record Dates

First Submitted

June 22, 2012

First Posted

June 28, 2012

Study Start

June 1, 2012

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

May 5, 2015

Record last verified: 2015-05

Locations

US(1)