- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01982123
SPECT/CT in Measuring Lung Function in Patients With Cancer Undergoing Radiation Therapy
Pulmonary Functional Imaging for Radiation Treatment Planning
Study Overview
Status
Conditions
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 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Washington
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Seattle, Washington, United States, 98109
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
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Seattle, Washington, United States, 98133
- ProCure Proton Therapy Center-Seattle
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT mid-radiation and post-radiation
Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT
Other Names:
Undergo 99mTc-MAA SPECT/CT
Other Names:
Undergo 99mTc-DTPA SPECT/CT
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spatial Stability of Lung Perfusion and Ventilation Over Time, as Assessed Using 99mTc-MAA SPECT/CT
Time Frame: Baseline to up to 3 months post-treatment
|
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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiation Dose With 50% Decrease in Lung Perfusion, Assessed Using 99mTc-MAA and 99mTc-DTPA SPECT/CT
Time Frame: Baseline to up to 3 months post-treatment
|
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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Baseline to up to 3 months post-treatment
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Radiopharmaceuticals
- Anticoagulants
- Antidotes
- Chelating Agents
- Sequestering Agents
- Iron Chelating Agents
- Calcium Chelating Agents
- Edetic Acid
- Pentetic Acid
- Technetium Tc 99m Aggregated Albumin
- Technetium Tc 99m Pentetate
Other Study ID Numbers
- 8180 (University of Washington)
- P30CA015704 (U.S. NIH Grant/Contract)
- NCI-2013-01774 (REGISTRY: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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