NCT00531180

Brief Summary

Objectives: Primary Objective: 1\. To determine the correlation between 4-dimensional computed tomography (4D CT) derived ventilation and single photon emission tomography (SPECT) aerosol Tc-99m determined ventilation. Secondary Objective:

  1. 1.To evaluate the reproducibility of the 4D CT derived ventilation and to obtain an estimate of the variance in a single setting.
  2. 2.To assess the correlation between hypoperfused and hypoventilated pulmonary regions in patients with thoracic malignancies.
  3. 3.To investigate the effect of continuous positive airway pressure (CPAP) on ventilation and tumor motion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 21, 2007

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2007

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2018

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

11.1 years

First QC Date

September 14, 2007

Last Update Submit

October 23, 2018

Conditions

Esophageal CancerLung Cancer

Keywords

Esophageal CancerLung CancerThoracic Malignancies4D CT scansLung Function

Outcome Measures

Primary Outcomes (1)

  • Correlation between 4-dimensional computed tomography (4D CT) derived ventilation and single photon emission tomography (SPECT) aerosol Tc-99m determined ventilation

    2 years

Study Arms (1)

4-DCT Ventilation Validation

EXPERIMENTAL
Procedure: 4D CT scansProcedure: Lung Function Imaging

Interventions

4D CT scansPROCEDURE

Three 4D CT scans will be performed. After you are out of the CT scanner, ventilation images will be calculated from the 4D CT images and will be compared with the standard ventilation imaging method.

4-DCT Ventilation Validation
Lung Function ImagingPROCEDURE

Lung function imaging performed to provide information on how well the lungs work, how air moves into the lungs with breathing, and blood circulation into the lungs.

4-DCT Ventilation Validation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with pathologic diagnosis of esophagus or lung cancer (Stage I through IV).
  • Patients must be able to lie flat for the duration of the treatment planning sessions.
  • Patients must sign informed consent.
  • Patients who are scheduled to receive radiation therapy.
  • A cohort of 6 lung cancer patients whose primary tumors move greater than 1 cm will be recruited (CPAP cohort).

You may not qualify if:

  • Significant pleural effusion as evaluated by the attending Radiation Oncologist is excluded.
  • Women of childbearing potential (A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months \[i.e., who has had menses at any time in the preceding 24 consecutive months\]) and male participants must practice effective contraception (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study.
  • Patients with severe COPD or asthma will be excluded from the CPAP cohort.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Esophageal NeoplasmsLung Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Heath Skinner, MD, PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2007

First Posted

September 18, 2007

Study Start

August 21, 2007

Primary Completion

September 21, 2018

Study Completion

September 21, 2018

Last Updated

October 25, 2018

Record last verified: 2018-10

Locations

US(1)