search
Back to results

Implantation of Markers for the Radiotherapy of Lung Cancer Patients

Primary Purpose

Lung Cancer

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
radiation therapy treatment planning/simulation
implanted fiducial-based imaging
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IA non-small cell lung cancer, stage IB non-small cell lung cancer, stage IIA non-small cell lung cancer, stage IIB non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Diagnosis of non-small cell lung cancer

    • Stage I-IIIB disease
  • No prior surgical tumor resection
  • Respiration-induced tumor motion > 5 mm
  • Recruited by attending physician or research nurse at the Medical College of Virginia Hospitals

PATIENT CHARACTERISTICS:

  • Not pregnant
  • No insufficient lung function or other parameters prohibiting a bronchoscopy
  • Not a prisoner or institutionalized

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Concurrent chemotherapy allowed

Sites / Locations

  • Virginia Commonwealth University Massey Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic

Arm Description

Patients undergo implantation of radio-opaque markers into the primary lesion and affected lymph nodes by bronchoscopy. Patients then undergo routine 4D CT, 4D CBCT, fluoroscopy, and x-ray imaging during standard stereotactic radiation therapy (early stage tumors) or conventionally fractionated radiation therapy (advanced stage tumors).

Outcomes

Primary Outcome Measures

Number of dropped markers
Marker misplacements
Implantation-related side effects
Visibility of markers on CT and x-rays
Positional reliability of markers
Usability for patient treatment

Secondary Outcome Measures

Full Information

First Posted
March 4, 2009
Last Updated
December 18, 2013
Sponsor
Virginia Commonwealth University
search

1. Study Identification

Unique Protocol Identification Number
NCT00856427
Brief Title
Implantation of Markers for the Radiotherapy of Lung Cancer Patients
Official Title
Implantation of Markers for the Radiotherapy of Lung Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
February 2008 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This clinical trial studies imaging markers in planning radiation therapy in patients with lung cancer. Implanting markers in the tumor that can be seen using imaging procedures during radiation therapy may allow x-rays to be sent directly to the tumor and cause less damage to normal tissue.
Detailed Description
OBJECTIVES: To acquire experience in the marker implantation process for mediastinal lymph nodes and primary lung tumors in patients with stage I-IIIB non-small cell lung cancer. To characterize the potential side effects involved in the use of markers in these patients. To analyze the positional stability of lung markers in these patients over a radiotherapy series. To acquire experience in the use of markers for treatment planning and radiotherapy in these patients. OUTLINE: Patients undergo implantation of ≥ 1 small radio-opaque Visicoil™ marker into or close to the primary lesion and affected lymph nodes by bronchoscopy. Patients then undergo x-rays to document marker location, detect potentially dropped markers, and diagnose operation-related side effects (i.e., pneumothorax). After marker implantation, patients undergo stereotactic or conventionally fractionated radiotherapy for 30-33 daily fractions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IA non-small cell lung cancer, stage IB non-small cell lung cancer, stage IIA non-small cell lung cancer, stage IIB non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic
Arm Type
Experimental
Arm Description
Patients undergo implantation of radio-opaque markers into the primary lesion and affected lymph nodes by bronchoscopy. Patients then undergo routine 4D CT, 4D CBCT, fluoroscopy, and x-ray imaging during standard stereotactic radiation therapy (early stage tumors) or conventionally fractionated radiation therapy (advanced stage tumors).
Intervention Type
Radiation
Intervention Name(s)
radiation therapy treatment planning/simulation
Intervention Description
Undergo implantation of radio-opaque markers
Intervention Type
Procedure
Intervention Name(s)
implanted fiducial-based imaging
Intervention Description
Undergo implantation of radio-opaque markers
Primary Outcome Measure Information:
Title
Number of dropped markers
Time Frame
up to 5 years
Title
Marker misplacements
Time Frame
up to 5 years
Title
Implantation-related side effects
Time Frame
up to 5 years
Title
Visibility of markers on CT and x-rays
Time Frame
up to 5 years
Title
Positional reliability of markers
Time Frame
Up to 5 years
Title
Usability for patient treatment
Time Frame
up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of non-small cell lung cancer Stage I-IIIB disease No prior surgical tumor resection Respiration-induced tumor motion > 5 mm Recruited by attending physician or research nurse at the Medical College of Virginia Hospitals PATIENT CHARACTERISTICS: Not pregnant No insufficient lung function or other parameters prohibiting a bronchoscopy Not a prisoner or institutionalized PRIOR CONCURRENT THERAPY: See Disease Characteristics Concurrent chemotherapy allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth Weiss, MD
Organizational Affiliation
Massey Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0037
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Implantation of Markers for the Radiotherapy of Lung Cancer Patients

We'll reach out to this number within 24 hrs