NCT00500513

Brief Summary

Objectives:

  • To determine the safety of fiducial implantation.
  • To determine the extent/rate of migration of radio-opaque fiducials placed in lung tumors and adjacent normal tissue.
  • To compare real-time portal imaging-based fiducial tracking with measurement of three-dimensional motion by four-dimensional CT scanning to determine how many fiducials are needed to track a tumor.
  • To determine if intra-fractional lung tumor motion changes during a course of treatment, and when during the treatment this occurs.
  • To correlate the position of internal fiducials with the position of the external patient surface during respiration.
  • To quantify the residual motion of the clinical target volume during radiotherapy gated using external fiducials.
  • To verify the adequacy of the treatment portal margins in encompassing the residual motion of the clinical target volume.
  • To determine if radio-opaque fiducial placement adjacent to the trachea (which does not move) can reduce daily setup inaccuracies, and so spare normal tissue.
  • To determine the motion of hilar adenopathy (if any), and whether it correlates with motion of the primary tumor.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
Completed

Started Apr 2004

Longer than P75 for not_applicable 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
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 10, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 12, 2007

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 1, 2013

Status Verified

January 1, 2013

Enrollment Period

3.2 years

First QC Date

July 10, 2007

Last Update Submit

January 30, 2013

Conditions

Lung Cancer

Keywords

Lung CancerRespiratory-Induced Tumor MotionTumor MotionPulmonary FunctionFiducial Marker

Outcome Measures

Primary Outcomes (1)

  • Number of patients experiencing motion of one or more fiducials during the course of radiation therapy

    Baseline, 6 weeks

Study Arms (1)

Implanted Markers + CT + RT

EXPERIMENTAL
Procedure: CT ScansProcedure: Implanted markersRadiation: Radiation Treatment (RT)

Interventions

CT ScansPROCEDURE

CT scan performed weekly to measure how much the tumor moves + additional pulmonary function measurements.

Also known as: Computed Tomography, 4-D CT Scan
Implanted Markers + CT + RT
Implanted markersPROCEDURE

Implanted radio-opaque fiducial markers, diameter of 1.0 - 2.0 mm, inserted through a catheter at several chest locations using a flexible bronchoscope

Implanted Markers + CT + RT
Radiation Treatment (RT)RADIATION

Radiotherapy incorporating respiratory treatment delivery

Also known as: RT, XRT
Implanted Markers + CT + RT

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patient must be undergoing radiation treatment.
  • Planned course of radiation treatment must be greater than or equal to 6 weeks.
  • The patient is able to tolerate bronchoscopy: a. Able to maintain oxygen saturation \>95% on room air nasal cannula supplementation \<5L/min, b. Can tolerate supine position without respiratory difficulties, c. Has normal hemodynamic parameters, d. Has normal coagulation profile
  • The patient is a candidate for bronchogenic placement of seeds.
  • The patient has an identifiable tumor on a CT scan.
  • The patient has signed the consent form.

You may not qualify if:

  • The patient has had previous radiation to the thorax.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Fiducial MarkersRadiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Reference StandardsWeights and MeasuresInvestigative TechniquesProstheses and ImplantsEquipment and SuppliesRadiation Equipment and SuppliesTherapeutics

Study Officials

  • George Starkschall, PhD

    M.D. Anderson Cancer Center

    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
SPONSOR

Study Record Dates

First Submitted

July 10, 2007

First Posted

July 12, 2007

Study Start

April 1, 2004

Primary Completion

June 1, 2007

Study Completion

December 1, 2011

Last Updated

February 1, 2013

Record last verified: 2013-01

Locations

US(1)