Implantation of Markers for the Radiotherapy of Lung Cancer Patients

Lung Cancer Clinical Trial

Official title:

Implantation of Markers for the Radiotherapy of Lung Cancer Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00856427
• Other study ID #: MCC-11284
• Secondary ID: HM11284CDR000063
• Status: Terminated
• Phase: Phase 1
• First received: March 4, 2009
• Last updated: December 18, 2013
• Start date: February 2008
• Est. completion date: August 2012

Study information

• Verified date: December 2013
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: August 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Radiation:
• radiation therapy treatment planning/simulation
Undergo implantation of radio-opaque markers

Procedure:
• implanted fiducial-based imaging
Undergo implantation of radio-opaque markers

Locations

Country	Name	City	State
United States	Virginia Commonwealth University Massey Cancer Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of dropped markers		up to 5 years	No
Primary	Marker misplacements		up to 5 years	No
Primary	Implantation-related side effects		up to 5 years	Yes
Primary	Visibility of markers on CT and x-rays		up to 5 years	No
Primary	Positional reliability of markers		Up to 5 years	No
Primary	Usability for patient treatment		up to 5 years	No