Non-small Cell Lung Cancer Clinical Trial
Official title:
Pilot Study of Regional Lung Ventilation: Comparing Ventilation Images Computed From 4D CTs vs. Traditional Nuclear Medicine Ventilation Images
Verified date | March 2017 |
Source | H. Lee Moffitt Cancer Center and Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a prospective study of ventilation image comparison for lung functional information incorporation in thoracic cancer treatment planning.
Status | Completed |
Enrollment | 3 |
Est. completion date | August 23, 2016 |
Est. primary completion date | April 16, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
H. Lee Moffitt Cancer Center and Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Up to 1 year |
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