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

This study has been terminated.
(business decision)
Sponsor:
Information provided by (Responsible Party):
Billy W. Loo Jr., Stanford University
ClinicalTrials.gov Identifier:
NCT01034514
First received: December 16, 2009
Last updated: May 3, 2017
Last verified: May 2017
  Purpose
To develop and investigate a novel radiotherapy technique for preserving lung function based on a map of lung function.

Condition Intervention Phase
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
Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic
Official Title: 4D-CT-based Ventilation Imaging for Adaptive Functional Guidance in Radiotherapy

Resource links provided by NLM:


Further study details as provided by Billy W. Loo Jr., Stanford University:

Primary Outcome Measures:
  • The overall correlation between the 4D-CT and the SPECT ventilation images. [ Time Frame: 24 months ]

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 ]

Enrollment: 35
Actual Study Start Date: December 2009
Study Completion Date: June 24, 2014
Primary Completion Date: June 24, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 4DCT arm
Patients breathe in 99mTc-DTPA and then undergo ventilation scans using a SPECT scanner over 2 hours. Patients also receive 99mTc-MAA IV and then undergo perfusion scans using a SPECT scanner over 2 hours. Patients may also undergo a pre- and post-treatment Xe-CT ventilation scan over 15 minutes and a pre-treatment 4D-CT scan over 5-10 minutes.
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   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Stanford, California, United States, 94305
Sponsors and Collaborators
Billy W. Loo Jr.
Investigators
Principal Investigator: Billy Loo Stanford University
  More Information

Responsible Party: Billy W. Loo Jr., Associate Professor of Radiation Oncology, Stanford University
ClinicalTrials.gov Identifier: NCT01034514     History of Changes
Other Study ID Numbers: LUN0034
SU-04232009-2382 ( Other Identifier: Stanford University )
Study First Received: December 16, 2009
Last Updated: May 3, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Technetium Tc 99m Aggregated Albumin
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 25, 2017