MDACC Study Summary 2006-0698

Study Summary
No. 2006-0698:.......Esophagus; Lung......Thomas Guerrero......Radiation Oncology

Study Summary Title



Study Summary Number:	2006-0698

Study Title:	Phase II trial comparing 4-dimensional computed tomography derived ventilation versus SPECT/CT Tc-99m aerosol ventilation in patients with thoracic malignancies

Physician

New Patient Referral



Name:	Thomas Guerrero	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Radiation Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-2345 Contact us about clinical trials

General Information



Disease Group:	Esophagus Lung	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	n/a

Treatment Agents:	None	Home Care:	n/a

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	n/a


Description/ Intervention:	The goal of this clinical research study is to compare a new lung function calculation method with 2 standard imaging methods. A secondary goal is to evaluate the effect of airway pressure on lung function and tumor motion.

Study Objectives / Outcomes

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. To evaluate the reproducibility of the 4D CT derived ventilation and to obtain an estimate of the variance in a single setting.

2. To assess the correlation between hypoperfused and hypoventilated pulmonary regions in patients with thoracic malignancies.

3. To investigate the effect of continuous positive airway pressure (CPAP) on ventilation and tumor motion.

Study Status Information



Study Activation / Registration Date:	08/21/2007

IRB Review and Approval Date:	08/21/2007

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Closed

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients with pathologic diagnosis of esophagus or lung cancer (Stage I through IV).

2) Patients must be able to lie flat for the duration of the treatment planning sessions.

3) Patients must sign informed consent.

4) Patients who are scheduled to receive radiation therapy.

5) A cohort of 6 lung cancer patients whose primary tumors move greater than 1 cm will be recruited (CPAP cohort).

Exclusion Criteria:

1) Significant pleural effusion as evaluated by the attending Radiation Oncologist is excluded.

2) 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.

3) Patients with severe COPD or asthma will be excluded from the CPAP cohort.

Links

Registration Number: NCT00531180
Study Information on Clinical Trials Registry (clinicaltrials.gov)