NCT00610844

Brief Summary

The purpose of the study is to evaluate the effectiveness of radiofrequency ablation by pathological correlation and to characterize the tissue response after treatment of primary and secondary pulmonary tumors.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_2 lung-cancer

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

April 1, 2004

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 8, 2008

Completed
Last Updated

February 20, 2008

Status Verified

November 1, 2007

Enrollment Period

2.1 years

First QC Date

January 28, 2008

Last Update Submit

February 15, 2008

Conditions

Lung CancerLung Metastasis

Keywords

lung cancerlung metastasisradiofrequency ablation

Outcome Measures

Primary Outcomes (1)

  • rate of incomplete treated tumors

    3 days

Secondary Outcomes (1)

  • pathologic tissue changes, rate of major and minor complications

    6 months

Study Arms (1)

1

EXPERIMENTAL

pulmonary radiofrequency ablation

Procedure: pulmonary radiofrequency ablation

Interventions

pulmonary radiofrequency ablationPROCEDURE

CT-guided pulmonary radiofrequency ablation

1

Eligibility Criteria

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

You may qualify if:

  • Signed informed consent for radiofrequency ablation and surgery
  • Maximum of 3 lung tumors
  • Maximum tumor size 5 cm
  • Must be able to receive standard surgery

You may not qualify if:

  • Pathological coagulation tests
  • Pregnant or breast feeding
  • Maximum tumor size more than 5 cm
  • Bilateral secondary lung cancer with more than 3 tumors
  • Inoperable patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Diagnostic Radiology

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Philippe L Pereira, MD

    Department of Diagnostic Radiology, University of Tübingen

    PRINCIPAL INVESTIGATOR

  • Hermann Aebert, MD

    Department of thoracic surgery, University of Tübingen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 28, 2008

First Posted

February 8, 2008

Study Start

April 1, 2004

Primary Completion

May 1, 2006

Last Updated

February 20, 2008

Record last verified: 2007-11

Locations

DE(1)