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Pilot Study of Regional Lung Ventilation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03077113
Recruitment Status : Completed
First Posted : March 10, 2017
Last Update Posted : March 13, 2017
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

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

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Diagnostic Test: 4-D CT Scan Diagnostic Test: SPECT-CT Scan Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study of Regional Lung Ventilation: Comparing Ventilation Images Computed From 4D CTs vs. Traditional Nuclear Medicine Ventilation Images
Actual Study Start Date : October 15, 2012
Actual Primary Completion Date : April 16, 2015
Actual Study Completion Date : August 23, 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Diagnostic Test: 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.
Other Name: 4-D computed tomography

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.
Other Name: Single-photon emission computed tomography

Primary Outcome Measures :
  1. Rate of Correlation of Ventilation Images [ Time Frame: Up to 1 year ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03077113

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United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
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Principal Investigator: Thomas Dilling, M.D. H. Lee Moffitt Cancer Center and Research Institute

Additional Information:
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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute Identifier: NCT03077113     History of Changes
Other Study ID Numbers: MCC-17070
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
lung cancer
radiation therapy
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms