SPECT/CT in Measuring Lung Function in Patients With Lung Cancer Undergoing Radiation Therapy
Conditions
Extensive Stage Small Cell Lung Cancer - Limited Stage Small Cell Lung Cancer - Occult Non-small Cell Lung Cancer - Recurrent Non-small Cell Lung Cancer - Recurrent Small Cell Lung Cancer - Stage IA Non-small Cell Lung Cancer - Stage IB Non-small Cell Lung Cancer - Stage IIA Non-small Cell Lung Cancer - Stage IIB Non-small Cell Lung Cancer - Stage IIIA Non-small Cell Lung Cancer - Stage IIIB Non-small Cell Lung Cancer - Stage IV Non-small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms - Small Cell Lung Carcinoma
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: technetium Tc 99m-labeled macroaggregated albumin Type: Radiation
Name: technetium Tc 99m DTPA Type: Drug
Name: single photon emission computed tomography Type: Procedure
Name: computed tomography Type: Procedure
Name: fludeoxyglucose F 18 Type: Radiation
Name: positron emission tomography Type: Procedure
Name: computed tomography Type: Procedure
Overall Status
Recruiting
Summary
This pilot clinical trial studies single photon emission computed tomography (SPECT)/computed tomography (CT) in measuring lung function in patients with lung cancer undergoing radiation therapy. Diagnostic procedures that measure lung function may help doctors find healthy lung tissue and allow them to plan better treatment.
Detailed Description
PRIMARY OBJECTIVES:

I. To utilize SPECT/CT imaging with technetium Tc-99m microaggregated albumin (99mTc-MAA) and 99mTc-diethylenetriamine pentaacetic acid (99mTc-DTPA) to identify functional lung on serial imaging in patients receiving radiation treatment for lung cancer, as well as to characterize reproducibility of perfusion and ventilation in non-irradiated lung tissue.

SECONDARY OBJECTIVES:

I. To estimate the dose response relationship on multiple spatial scales (global lung, regional lung, lung image voxel) between radiation dose and changes in lung ventilation and perfusion, both acutely (mid-radiation treatment) and long term (3 months post-treatment), using SPECT/CT imaging with 99mTc-MAA and 99mTc-DTPA.

II. To estimate the degree of radiation response in lung tissue with varying levels of function (i.e. compare radiation dose response of well ventilated and well perfused tissue against lung tissue with poor perfusion and ventilation).

TERTIARY OBJECTIVES:

I. To evaluate proton radiation therapy for functional lung sparing in lung cancer through treatment planning comparisons to conventional photon radiation therapy.

II. To evaluate the feasibility of incorporating standard-of-care fludeoxyglucose F 18 (18F-FDG) positron emission tomography (PET) images into proton and photon radiotherapy planning for dose escalation to functionally viable regions of gross thoracic disease.

OUTLINE:

Patients undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT at baseline, mid-radiation therapy (up to 1 week post-treatment), and at 3-6 months post-treatment. Patients also undergo a pre-treatment 18F FDG PET/CT scan per standard of care.

After completion of study, patients are followed up periodically.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 19 Years
Gender: Both
Criteria: Inclusion Criteria:

- Lung cancer patients receiving radiation treatment to the thorax to at least 45 Gy; both non-small cell and small cell patients are eligible; patient must have pathologic confirmation of diagnosis, or have an enlarging lung mass on at least two scans spaced 3 months apart, and FDG avidity on PET scan

- All stages of lung cancer are eligible, but patients must be planned for at least 45 Gy of radiation

- Patients are not required to have measurable disease; post-operative patients (patients who have had surgical resection of lung cancer) are eligible

- Patients must have pulmonary function as defined below:

- Abnormal pulmonary function test within 3 months of study entry

- Prior radiation to the lungs

- Prior surgical resection of lung tissue (i.e. wedge resection, lobectomy, or pneumonectomy)

- Clinical diagnosis of chronic obstructive pulmonary disease (COPD) or emphysema

- Ongoing oxygen use

- There are no limits on prior therapy; patients are allowed to have prior chemotherapy, radiation therapy, and surgery; patients are allowed to have concurrent chemotherapy with radiation treatment; patients are allowed to have chemotherapy after radiation treatment; patients are not allowed to have planned lung resection after radiation

- Ability to understand and the willingness to sign a written informed consent document

- Patients will typically be enrolled on this trial prior to beginning the radiation treatment course; however, if a patient has had a SPECT/CT 99mTc-MAA and 99mTc-DTPA scan as part of routine medical care within 6 weeks prior to initiation of radiation treatment, he/she is eligible for trial enrollment up to the last day of the radiation treatment course

Exclusion Criteria:

- Patients must not be planned for lung resection after radiation therapy

- Patients receiving < 45 Gy radiation

- Patients who received radiation to the chest within the past 6 months

- Patients unable to tolerate a SPECT/CT 99mTc-MAA and 99mTc-DTPA scan

- Patients who are not planning to adhere to the required follow up schedule as outlined in this protocol

- Pregnant women

- Women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception

- Patients unable to provide informed consent
Locations
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Status: Recruiting
Contact: Jing Zeng - 206-598-4100
ProCure Seattle (SCCA Proton Therapy Center)
Seattle, Washington, United States
Status: Recruiting
Contact: Jing Zeng - 206-598-4100
Start Date
January 2014
Sponsors
University of Washington
Source
University of Washington
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page