Pilot Study of Regional Lung Ventilation

NCT ID: NCT03077113

Last Updated: 2017-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-15
• Study Completion Date: 2016-08-23

Brief Summary

This is a prospective study of ventilation image comparison for lung functional information incorporation in thoracic cancer treatment planning.

Detailed Description

Investigators hypothesize that a high resolution regional ventilation image (HRVI) based on 4D-CT imaging will correlate with the current low resolution state-of-the-art (SPECT-CT), which is the conventional way of measuring ventilation. HRVI may be a tool that could be widely used throughout the radiation therapy community because most radiation oncologists routinely employ 4D-CT technology in their own clinics. Investigators plan to test this hypothesis by comparing ventilation patterns on SPECT-CT images to HRVIs using a DICE analysis. As SPECT ventilation imaging is not included in our standard care, this study thus is designed as a pilot study.

Based on published data, the difference between the two methods for calculating the regional ventilation in the lower 50% ventilation volume is expected to have a standard deviation of about 0.1. Therefore, the 95% confidence interval for the difference in the regional ventilation between SPECT-CT and 4D-CT pre-treatment would have a width of no more than 0.14 if 10 patients are enrolled and as small as 0.10 when 20 patients are registered.

Conditions

Non-small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Ventilation Images for Comparison

Standard of Care: 4-D CT scan will be used to make a radiation treatment plan.

SPECT-CT Scan: This second scan will be done on another day to make a treatment plan for comparison to the first plan.

Group Type: OTHER

4-D CT Scan

Intervention Type: DIAGNOSTIC_TEST

The 4-D CT scan shows how the tumor moves when patients breathe so that motion can be taken into account when planning the radiation. This is the usual way of planning lung radiation and everyone in this study will be planned using a 4-D CT scan.

SPECT-CT Scan

Intervention Type: DIAGNOSTIC_TEST

It may be possible to make a more accurate plan by using a SPECT-CT scan for planning that would result in less damage to healthy lung tissue. This is not yet proven. A SPECT-CT scan uses a special camera to detect radioactivity to produce pictures which can lead to more precise information.

Interventions

4-D CT Scan

The 4-D CT scan shows how the tumor moves when patients breathe so that motion can be taken into account when planning the radiation. This is the usual way of planning lung radiation and everyone in this study will be planned using a 4-D CT scan.

Intervention Type: DIAGNOSTIC_TEST

SPECT-CT Scan

It may be possible to make a more accurate plan by using a SPECT-CT scan for planning that would result in less damage to healthy lung tissue. This is not yet proven. A SPECT-CT scan uses a special camera to detect radioactivity to produce pictures which can lead to more precise information.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

4-D computed tomography; Single-photon emission computed tomography

Eligibility Criteria

Inclusion Criteria

• Patients that have early stage non-small cell lung cancer or clinical suspicion of the same in cases where the lesion is not amenable to biopsy but is enlarging and PET-positive. All patients are to be treated with stereotactic body radiation therapy as a monotherapy.
• Eligible patients must have appropriate staging studies identifying them as specific subsets of AJCC 7th edition stage I or II based on only one of the following combinations of TNM staging:

• T1a-b, N0, M0
• T2a, N0, M0
• T3 (invading the chest wall, <5 cm in diameter) N0 M0
• Must be at least 18 years of age
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Women of childbearing potential and male participants must use an effective contraceptive method such as condom/diaphragm and spermicidal foam, intrauterine device, or prescription birth control pills.

Exclusion Criteria

• Patients with T2b tumors or T3 tumors >5 cm or patients with tumors involving the central chest/structures of the mediastinum;
• Primary tumor of any T-stage within or touching the zone of the proximal bronchial tree, defined as a volume 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi.
• Direct evidence of regional or distant metastases after appropriate staging studies
• Patients with active systemic, pulmonary, or pericardial infection;
• Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.
• Patients that receive chemotherapy (induction or sequential)
• Psychiatric or addictive disorders that impair subject's voluntary ability to participate in informed consent or protocol procedures

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Dilling, M.D.

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Locations

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Countries

United States

Other Identifiers

MCC-17070

Identifier Type: -

Identifier Source: org_study_id