NCT01034514

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for early_phase_1 lung-cancer

Timeline
Completed

Started Dec 2009

Typical duration for early_phase_1 lung-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2009

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2014

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

4.6 years

First QC Date

December 16, 2009

Last Update Submit

May 3, 2017

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • The overall correlation between the 4D-CT and the SPECT ventilation images.

    24 months

Secondary Outcomes (1)

  • 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

Study Arms (1)

4DCT arm

EXPERIMENTAL

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 systemDevice: Discovery ST multislice PET/CT scannerDevice: Infinia Hawkeye SPECT/CT gamma cameraDevice: Pinnacle3 treatment planning systemDevice: SKYLight nuclear cameraDrug: DTPADrug: TECHNETIUM TC 99M MAA

Interventions

Real-time Position Management systemDEVICE

Standard of Care

Also known as: RPM System
4DCT arm
Discovery ST multislice PET/CT scannerDEVICE

Standard of Care

Also known as: Positron Emission Tomography
4DCT arm
Infinia Hawkeye SPECT/CT gamma cameraDEVICE

Standard of Care

Also known as: Single-photon emission computed tomography
4DCT arm
Pinnacle3 treatment planning systemDEVICE

Standard of Care

Also known as: Radiation Treatment Planning
4DCT arm
SKYLight nuclear cameraDEVICE

Standard of Care

Also known as: Philips Medical Systems
4DCT arm
DTPADRUG

1 mCi; inhalation

Also known as: DRAXIS Specialty Pharmaceuticals Inc.
4DCT arm
TECHNETIUM TC 99M MAADRUG

3 mCi; iv

Also known as: DRAXIS Specialty Pharmaceuticals Inc.
4DCT arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Positron-Emission TomographyTomography, Emission-Computed, Single-PhotonPentetic AcidTechnetium

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisImage EnhancementPhotographyRadionuclide ImagingTomographyDiagnostic Techniques, RadioisotopePolyaminesAminesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsElements, RadioactiveElementsInorganic ChemicalsMetals, HeavyTransition ElementsRadioisotopesIsotopesMetals

Study Officials

  • Billy Loo

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Radiation Oncology

Study Record Dates

First Submitted

December 16, 2009

First Posted

December 17, 2009

Study Start

December 1, 2009

Primary Completion

June 24, 2014

Study Completion

June 24, 2014

Last Updated

May 8, 2017

Record last verified: 2017-05

Locations

US(1)