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

Billy W. Loo Jr.

Status and phase: Terminated; Early Phase 1

Conditions: Lung Cancer

Treatments: Device: Infinia Hawkeye SPECT/CT gamma camera; Drug: TECHNETIUM TC 99M MAA; Device: Real-time Position Management system; Device: SKYLight nuclear camera; Drug: DTPA; Device: Pinnacle3 treatment planning system; Device: Discovery ST multislice PET/CT scanner

Study type: Interventional

Funder types: Other

Identifiers

NCT01034514

SU-04232009-2382 (Other Identifier)

LUN0034

Details and patient eligibility

About

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

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

35 participants in 1 patient group

4DCT arm

Experimental group

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.

Treatment:

Device: Discovery ST multislice PET/CT scanner

Drug: DTPA

Device: Pinnacle3 treatment planning system

Device: SKYLight nuclear camera

Device: Real-time Position Management system

Drug: TECHNETIUM TC 99M MAA

Device: Infinia Hawkeye SPECT/CT gamma camera