Pilot Study of Regional Lung Ventilation

NCT03077113 | Completed

• 1 other identifier: MCC-17070
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-small Cell Lung Cancer

Keywords

lung cancer; radiation therapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Ventilation Images for Comparison

OTHER

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; Diagnostic Test: SPECT-CT Scan

Interventions

4-D CT Scan 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.

Also known as: 4-D computed tomography

Ventilation Images for Comparison

SPECT-CT Scan 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.

Also known as: Single-photon emission computed tomography

Ventilation Images for Comparison

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trials website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Single Photon Emission Computed Tomography Computed Tomography; Tomography, Emission-Computed, Single-Photon

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Thomas Dilling, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: March 10, 2017
• Study Start: October 15, 2012
• Primary Completion: April 16, 2015
• Study Completion: August 23, 2016
• Last Updated: March 13, 2017

Record last verified: 2017-03

Locations

US (1)