Clinical trial · Interventional
4D-CT-based Ventilation Imaging for Adaptive Functional Guidance in Radiotherapy
NCT01034514CI-TRIAL-00027406terminatedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): business decision
Summary
Brief summary (as posted)
To develop and investigate a novel radiotherapy technique for preserving lung function based on a map of lung function.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Discovery ST multislice PET/CT scanner | Device | — | UNRESOLVED |
| DTPA | Drug | — | UNRESOLVED |
| Infinia Hawkeye SPECT/CT gamma camera | Device | — | UNRESOLVED |
| Pinnacle3 treatment planning system | Device | — | UNRESOLVED |
| Real-time Position Management system | Device | — | UNRESOLVED |
| SKYLight nuclear camera | Device | — | UNRESOLVED |
| TECHNETIUM TC 99M MAA | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 4DCT arm
- description
- 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.
- interventionNames
- 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
Primary outcomes (1)
- measure
- The overall correlation between the 4D-CT and the SPECT ventilation images.
- timeFrame
- 24 months
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.