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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-01774 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 8180 | Other Identifier | University of Washington | |
| P30CA015704 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot clinical trial studies single photon emission computed tomography (SPECT)/computed tomography (CT) in measuring lung function in patients with cancer undergoing radiation therapy. Diagnostic procedures that measure lung function may help doctors find healthy lung tissue and allow them to plan better treatment.
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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPECT/CT Mid-& Post-RT | Experimental | Investigational 99mTc-MAA and 99mTc-DTPA SPECT/CT mid-radiation therapy (up to 1 week post-treatment), and at 3-6 months post-treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPECT/CT | Diagnostic Test | Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT mid-radiation and post-radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Spatial Stability of Lung Perfusion and Ventilation Over Time, as Assessed Using 99mTc-MAA SPECT/CT | Perfusion and ventilation on SPECT/CT pre-radiation, mid-radiation, and post-radiation were compared to assess stability over time. Coefficient of determination (R²) was generated based on voxel-based comparisons between scans (R²=1 means perfect reproducibility in perfusion and ventilation between scans), based on regions outside the radiation field. | Baseline to up to 3 months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Radiation Dose With 50% Decrease in Lung Perfusion, Assessed Using 99mTc-MAA and 99mTc-DTPA SPECT/CT | For lung tissue inside the radiation field, changes in tracer uptake at the global lung, regional lung, and lung image voxel scales (compared to baseline) will be plotted against the radiation dose at the same scales to generate multiscale radiation dose response curves. These curves will be fit to linear and sigmoid dose-response functions. Lung regions in the upper quartile and lower quartile of ventilation and perfusion will also be separated out, and separate radiation dose response curves per region will be generated. We report here the dose at which there is a 50% decrease in lung perfusion based on the above analysis. |
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Inclusion Criteria:
Cancer patients receiving radiation treatment to the thorax to at least 45 Gy; 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
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Jing Zeng | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic (99mTc-MAA and 99mTc-DTPA SPECT/CT) | 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. Computed Tomography: Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT Computed Tomography: Undergo 18F FDG PET/CT Fludeoxyglucose F-18: Undergo 18F FDG PET/CT Positron Emission Tomography: Undergo 18F FDG PET/CT 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 31, 2013 |
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| Single Photon Emission Computed Tomography | Procedure | Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT |
|
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| Technetium Tc-99m Albumin Aggregated | Radiation | Undergo 99mTc-MAA SPECT/CT |
|
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| Technetium Tc-99m DTPA | Drug | Undergo 99mTc-DTPA SPECT/CT |
|
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| Baseline to up to 3 months post-treatment |
| ProCure Proton Therapy Center-Seattle |
| Seattle |
| Washington |
| 98133 |
| United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic (99mTc-MAA and 99mTc-DTPA SPECT/CT) | 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. Computed Tomography: Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT Computed Tomography: Undergo 18F FDG PET/CT Fludeoxyglucose F-18: Undergo 18F FDG PET/CT Positron Emission Tomography: Undergo 18F FDG PET/CT 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| Correlation between perfusion and ventilation on SPECT/CT scans pre-RT | Coefficient of determination (R²) between perfusion and ventilation per voxel on SPECT/CT scans prior to radiation treatment | Number | correlation coefficient |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Spatial Stability of Lung Perfusion and Ventilation Over Time, as Assessed Using 99mTc-MAA SPECT/CT | Perfusion and ventilation on SPECT/CT pre-radiation, mid-radiation, and post-radiation were compared to assess stability over time. Coefficient of determination (R²) was generated based on voxel-based comparisons between scans (R²=1 means perfect reproducibility in perfusion and ventilation between scans), based on regions outside the radiation field. | Posted | Number | correlation coefficient | Baseline to up to 3 months post-treatment |
|
|
| |||||||||||||||||||||||||||
| Secondary | Radiation Dose With 50% Decrease in Lung Perfusion, Assessed Using 99mTc-MAA and 99mTc-DTPA SPECT/CT | For lung tissue inside the radiation field, changes in tracer uptake at the global lung, regional lung, and lung image voxel scales (compared to baseline) will be plotted against the radiation dose at the same scales to generate multiscale radiation dose response curves. These curves will be fit to linear and sigmoid dose-response functions. Lung regions in the upper quartile and lower quartile of ventilation and perfusion will also be separated out, and separate radiation dose response curves per region will be generated. We report here the dose at which there is a 50% decrease in lung perfusion based on the above analysis. | Posted | Median | Full Range | Gy | Baseline to up to 3 months post-treatment |
|
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diagnostic (99mTc-MAA and 99mTc-DTPA SPECT/CT) | 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. Computed Tomography: Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT Computed Tomography: Undergo 18F FDG PET/CT Fludeoxyglucose F-18: Undergo 18F FDG PET/CT Positron Emission Tomography: Undergo 18F FDG PET/CT 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 | 0 | 12 | 0 | 12 | 0 | 12 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jing Zeng | University of Washington Medical Center | 2065984110 | jzeng13@uw.edu |
| Sep 3, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000072098 | Single Photon Emission Computed Tomography Computed Tomography |
| D014965 | X-Rays |
| D017785 | Photons |
| D013668 | Technetium Tc 99m Aggregated Albumin |
| D016284 | Technetium Tc 99m Pentetate |
| ID | Term |
|---|---|
| D015899 | Tomography, Emission-Computed, Single-Photon |
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014057 | Tomography, X-Ray Computed |
| D064847 | Multimodal Imaging |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |
| D004601 | Elementary Particles |
| D008027 | Light |
| D055620 | Optical Phenomena |
| D011840 | Radiation, Nonionizing |
| D015609 | Organotechnetium Compounds |
| D009942 | Organometallic Compounds |
| D009930 | Organic Chemicals |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004369 | Pentetic Acid |
| D011073 | Polyamines |
| D000588 | Amines |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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