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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01034514
• Other study ID #: LUN0034
• Secondary ID: SU-04232009-2382
• Status: Terminated
• Phase: Early Phase 1
• First received: December 16, 2009
• Last updated: May 3, 2017
• Start date: December 2009
• Est. completion date: June 24, 2014

Study information

• Verified date: May 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: June 24, 2014
• Est. primary completion date: June 24, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Device:
• Real-time Position Management system
Standard of Care
• Discovery ST multislice PET/CT scanner
Standard of Care
• Infinia Hawkeye SPECT/CT gamma camera
Standard of Care
• Pinnacle3 treatment planning system
Standard of Care
• SKYLight nuclear camera
Standard of Care

Drug:
• DTPA
1 mCi; inhalation
• TECHNETIUM TC 99M MAA
3 mCi; iv

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Billy W. Loo Jr.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The overall correlation between the 4D-CT and the SPECT ventilation images.		24 months
Secondary	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.		24 months