SPECT/CT in Measuring Lung Function in Patients With Cancer Undergoing Radiation Therapy
NCT ID: NCT01982123
Last Updated: 2018-12-13
Study Results
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View full resultsBasic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2014-01-17
2017-09-13
Brief Summary
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Detailed Description
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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 to the thorax, 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 cancers and other cancer in the thorax 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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SPECT/CT Mid-& Post-RT
Investigational 99mTc-MAA and 99mTc-DTPA SPECT/CT mid-radiation therapy (up to 1 week post-treatment), and at 3-6 months post-treatment.
SPECT/CT
Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT mid-radiation and post-radiation
Single Photon Emission Computed Tomography
Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT
Technetium Tc-99m Albumin Aggregated
Undergo 99mTc-MAA SPECT/CT
Technetium Tc-99m DTPA
Undergo 99mTc-DTPA SPECT/CT
Interventions
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SPECT/CT
Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT mid-radiation and post-radiation
Single Photon Emission Computed Tomography
Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT
Technetium Tc-99m Albumin Aggregated
Undergo 99mTc-MAA SPECT/CT
Technetium Tc-99m DTPA
Undergo 99mTc-DTPA SPECT/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must be planned for at least 45 Gy of thoracic radiation
* Patients are not required to have measurable disease; post-operative patients (patients who have had surgical resection of the lung) 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 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
19 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Washington
OTHER
Responsible Party
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Jing Zeng
Principal Investigator
Principal Investigators
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Jing Zeng
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Locations
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Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
ProCure Proton Therapy Center-Seattle
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2013-01774
Identifier Type: REGISTRY
Identifier Source: secondary_id
8180
Identifier Type: OTHER
Identifier Source: secondary_id
8180
Identifier Type: -
Identifier Source: org_study_id