Pilot Study of Regional Lung Ventilation

Study summary

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

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Key things to know

Main goalDiagnostic

This describes the study’s primary purpose.

What is being studied4-D CT Scan and SPECT-CT Scan

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 13, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?H. Lee Moffitt Cancer Center and Research Institute

Study sponsor

Study overview

What this study is about

Purpose: Diagnostic
Study type: Interventional
Phase: Not applicable
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Interventions being studied: Diagnostic Test: 4-D CT Scan; Diagnostic Test: SPECT-CT Scan

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 13, 2017. Always confirm current availability with the study team.

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