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Pilot Study of Regional Lung Ventilation

Primary Purpose

Non-small Cell Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
4-D CT Scan
SPECT-CT Scan
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Non-small Cell Lung Cancer focused on measuring lung cancer, radiation therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • H. Lee Moffitt Cancer Center and Research Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ventilation Images for Comparison

Arm Description

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.

Outcomes

Primary Outcome Measures

Rate of Correlation of Ventilation Images
The primary objective is to compare the regional ventilation using SPECT-CT and that as determined from the pre-treatment 4D-CT routinely collected at simulation in lung/abdominal patients (standard of care). 50% of the lower portion lung image will be used for the purpose of determining the regional ventilation for this protocol.

Secondary Outcome Measures

Full Information

First Posted
March 2, 2017
Last Updated
March 9, 2017
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03077113
Brief Title
Pilot Study of Regional Lung Ventilation
Official Title
Pilot Study of Regional Lung Ventilation: Comparing Ventilation Images Computed From 4D CTs vs. Traditional Nuclear Medicine Ventilation Images
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 15, 2012 (Actual)
Primary Completion Date
April 16, 2015 (Actual)
Study Completion Date
August 23, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
lung cancer, radiation therapy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ventilation Images for Comparison
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
4-D CT Scan
Other Intervention Name(s)
4-D computed tomography
Intervention Description
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
Intervention Name(s)
SPECT-CT Scan
Other Intervention Name(s)
Single-photon emission computed tomography
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of Correlation of Ventilation Images
Description
The primary objective is to compare the regional ventilation using SPECT-CT and that as determined from the pre-treatment 4D-CT routinely collected at simulation in lung/abdominal patients (standard of care). 50% of the lower portion lung image will be used for the purpose of determining the regional ventilation for this protocol.
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Dilling, M.D.
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

Links:
URL
https://moffitt.org/clinical-trials-research/
Description
Moffitt Cancer Center Clinical Trials website

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Pilot Study of Regional Lung Ventilation

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