Lung CarcinomaNCT01982123
SPECT/CT in Measuring Lung Function in Patients With Cancer Undergoing Radiation Therapy
A study testing SPECT/CT, Single Photon Emission Computed Tomography and Technetium Tc-99m Albumin Aggregated in people with Lung Carcinoma and Malignant Neoplasm, run by University of Washington at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Lung Carcinoma, Malignant Neoplasm
- What is being tested?
- SPECT/CT, Single Photon Emission Computed Tomography and Technetium Tc-99m Albumin Aggregated
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Jan 2014to 13 Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109
ProCure Proton Therapy Center-Seattle
Seattle, Washington, 98133
About this study
Official title: Pulmonary Functional Imaging for Radiation Treatment Planning
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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:
- 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
- Lung Carcinoma, Malignant Neoplasm
- Being tested
- SPECT/CT, Single Photon Emission Computed Tomography, Technetium Tc-99m Albumin Aggregated, Technetium Tc-99m DTPA
- Medical subject headings
- Lung Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPECT/CTDiagnostic test
Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT mid-radiation and post-radiation
Single Photon Emission Computed TomographyProcedure or surgery
Also called Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, single-photon emission computed tomography, SPECT
Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT
Technetium Tc-99m Albumin AggregatedRadiation
Also called Tc 99m-labeled MAA, Technetium Tc 99m-Labeled Macroaggregated Albumin
Undergo 99mTc-MAA SPECT/CT
Technetium Tc-99m DTPADrug
Also called 99m-technetium Diethylenetriaminepentaacetic Acid, Tc-99m-DTPA, Tc-DTPA
Undergo 99mTc-DTPA SPECT/CT
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: SPECT/CT; Procedure: Single Photon Emission Computed Tomography; Radiation: Technetium Tc-99m Albumin Aggregated; Drug: Technetium Tc-99m DTPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to up to 3 months post-treatment
Secondary outcomes (1)
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.
Measured: Baseline to up to 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study start17 Jan 2014
- Primary completion13 Sep 2017
- Study completion13 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jing Zeng, University of Washington
- Investigators
- Jing Zeng, Principal investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982123
- Sponsor's protocol ID
- 8180
- Other IDs
- NCI-2013-01774, 8180, P30CA015704
- Status last verified
- Nov 2018
- First submitted
- 22 Oct 2013
- Last updated
- 13 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Functional Imaging for Radiation Treatment Planning
- ClinicalTrials.gov ID
- NCT01982123
- Acronym / sponsor ID
- 8180
- Conditions
- Lung Carcinoma, Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Jan 2014 (actual)
- Primary completion
- 13 Sep 2017 (actual)
- Study completion
- 13 Sep 2017 (actual)
- First posted
- 13 Nov 2013 (estimated)
- Results
- Posted 13 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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:
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPECT/CT Mid-& Post-RT | Experimental | Diagnostic Test: SPECT/CT, Procedure: Single Photon Emission Computed Tomography, Radiation: Technetium Tc-99m Albumin Aggregated, Drug: Technetium Tc-99m DTPAInvestigational 99mTc-MAA and 99mTc-DTPA SPECT/CT mid-radiation therapy (up to 1 week post-treatment), and at 3-6 months post-treatment. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPECT/CTUndergo 99mTc-MAA and 99mTc-DTPA SPECT/CT mid-radiation and post-radiation | Diagnostic test | SPECT/CT Mid-& Post-RT |
| Single Photon Emission Computed TomographyAlso: Medical Imaging, Single Photon Emission Computed Tomography, Single Photon Emission Tomography, single-photon emission computed tomography, SPECTUndergo 99mTc-MAA and 99mTc-DTPA SPECT/CT | Procedure or surgery | SPECT/CT Mid-& Post-RT |
| Technetium Tc-99m Albumin AggregatedAlso: Tc 99m-labeled MAA, Technetium Tc 99m-Labeled Macroaggregated AlbuminUndergo 99mTc-MAA SPECT/CT | Radiation | SPECT/CT Mid-& Post-RT |
| Technetium Tc-99m DTPAAlso: 99m-technetium Diethylenetriaminepentaacetic Acid, Tc-99m-DTPA, Tc-DTPAUndergo 99mTc-DTPA SPECT/CT | Drug | SPECT/CT Mid-& Post-RT |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Zeng principal investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPECT/CT, Single Photon Emission Computed Tomography and Technetium Tc-99m Albumin Aggregated in people with Lung Carcinoma and Malignant Neoplasm, run by University of Washington at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2018; AzTrials last refreshed its copy on 2 Nov 2026.