4D-CT-based Ventilation Imaging for Adaptive Functional Guidance in Radiotherapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01034514
First received: December 16, 2009
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

To develop and investigate a novel radiotherapy technique for preserving lung function based on a map of lung function.


Condition Intervention
Lung Cancer
Device: Real-time Position Management system
Device: Discovery ST multislice PET/CT scanner
Device: Infinia Hawkeye SPECT/CT gamma camera
Device: Pinnacle3 treatment planning system
Device: SKYLight nuclear camera
Drug: DTPA
Drug: TECHNETIUM TC 99M MAA

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 4D-CT-based Ventilation Imaging for Adaptive Functional Guidance in Radiotherapy

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • The overall correlation between the 4D-CT and the SPECT ventilation images. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The difference between the local ventilation at simulation and during the treatment. Dose-volume or functional dose-volume metrics. The regression coefficient between the regional ventilation and time. The mean dose to the high-functional lung region. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: December 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Real-time Position Management system
    Standard of Care
    Other Name: RPM System
    Device: Discovery ST multislice PET/CT scanner
    Standard of Care
    Other Name: Positron Emission Tomography
    Device: Infinia Hawkeye SPECT/CT gamma camera
    Standard of Care
    Other Name: Single-photon emission computed tomography
    Device: Pinnacle3 treatment planning system
    Standard of Care
    Other Name: Radiation Treatment Planning
    Device: SKYLight nuclear camera
    Standard of Care
    Other Name: Philips Medical Systems
    Drug: DTPA
    1 mCi; inhalation
    Other Name: DRAXIS Specialty Pharmaceuticals Inc.
    Drug: TECHNETIUM TC 99M MAA
    3 mCi; iv
    Other Name: DRAXIS Specialty Pharmaceuticals Inc.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients must be greater than or equal to 18 years of age. There are no gender or ethnic restrictions.AJCC Stage I, II, III or IV lung cancer of any histology to be treated using radiotherapy will be eligible for this study.

Criteria

Inclusion Criteria:

  • Eligible disease(s)/stage(s) AJCC Stage I, II, III or IV lung cancer of any histology to be treated using radiotherapy will be eligible for this study. Note that we will carefully consider the inclusion of cases with turbulent flow or greater flow velocities (Cabahug et al., 1996; Crawford et al., 1990) and COPD cases (Magnant et al., 2006) due to the impaction of aerosol particles in central airways.
  • Allowable type and amount of prior therapy. Any types and amounts of prior therapy will be allowed for this study.
  • Age restriction and/or gender/ethnic restrictions
  • Patients must be greater than or equal to 18 years of age.
  • There are no gender or ethnic restrictions.
  • Life expectancy restrictions - None.
  • ECOG or Karnofsky Performance Status
  • Not employed. Note that patients will need to be sufficiently healthy to undergo audiovisual (AV) biofeedback to generate high quality 4D-CT images.
  • Requirements for organ and marrow function None.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Children (less than 18 years of age), pregnant women, Stanford employees or students, or prisoners will be excluded from this study.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01034514

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Laura Gable    650-736-0798    lauraw1@stanford.edu   
Contact: Cancer Clinical Trials Office    (650) 498-7061      
Principal Investigator: Tokihiro Yamamoto         
Sub-Investigator: Dr. A. Dimitrios Colevas         
Sub-Investigator: Chuong D Hoang         
Sub-Investigator: Dr. Robert E Merritt         
Sub-Investigator: Erik Mittra         
Sub-Investigator: Dr Andrew Quon         
Sub-Investigator: Joseph B. Shrager         
Sub-Investigator: Heather A. Wakelee         
Sub-Investigator: Richard I Whyte         
Principal Investigator: Billy Loo         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Billy Loo Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01034514     History of Changes
Other Study ID Numbers: LUN0034, SU-04232009-2382
Study First Received: December 16, 2009
Last Updated: July 2, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 29, 2014