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

May 3, 2017 updated by: Billy W. Loo Jr.
To develop and investigate a novel radiotherapy technique for preserving lung function based on a map of lung function.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • RPM System
Device: Discovery ST multislice PET/CT scanner
Standard of Care
Other Names:
  • Positron Emission Tomography
Device: Infinia Hawkeye SPECT/CT gamma camera
Standard of Care
Other Names:
  • Single-photon emission computed tomography
Device: Pinnacle3 treatment planning system
Standard of Care
Other Names:
  • Radiation Treatment Planning
Device: SKYLight nuclear camera
Standard of Care
Other Names:
  • Philips Medical Systems
Drug: DTPA
1 mCi; inhalation
Other Names:
  • DRAXIS Specialty Pharmaceuticals Inc.
Drug: TECHNETIUM TC 99M MAA
3 mCi; iv
Other Names:
  • DRAXIS Specialty Pharmaceuticals Inc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The overall correlation between the 4D-CT and the SPECT ventilation images.
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Billy W. Loo Jr.

Investigators

  • Principal Investigator: Billy Loo, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2009

Primary Completion (Actual)

June 24, 2014

Study Completion (Actual)

June 24, 2014

Study Registration Dates

First Submitted

December 16, 2009

First Submitted That Met QC Criteria

December 16, 2009

First Posted (Estimate)

December 17, 2009

Study Record Updates

Last Update Posted (Actual)

May 8, 2017

Last Update Submitted That Met QC Criteria

May 3, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUN0034
  • SU-04232009-2382 (Other Identifier: Stanford University)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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