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SPECT/CT in Measuring Lung Function in Patients With Lung Cancer Undergoing Radiation Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of Washington
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01982123
First received: October 22, 2013
Last updated: August 29, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
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
Radiation: technetium Tc 99m-labeled macroaggregated albumin
Drug: technetium Tc 99m DTPA
Procedure: single photon emission computed tomography
Procedure: computed tomography
Radiation: fludeoxyglucose F 18
Procedure: positron emission tomography

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pulmonary Functional Imaging for Radiation Treatment Planning for Lung Cancer

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Change in perfusion in lung tissue, assessed using 99mTc-MAA SPECT/CT [ Time Frame: Baseline to up to 3 months post-treatment ] [ Designated as safety issue: No ]
    Image sets from all time points fused using rigid registration. Regions of interest defined using automated & semi-automated methods, incl. simple thresholds & gradient-search algorithms. Each tracer's uptake value calculated for each voxel. For lung tissue outside radiation field, summary statistics (total regional uptake & mean regional uptake by lobe) compared across time points w/parametric & non-parametric testing. Voxel-based correlation, incl. Pearson linear & Spearman rank, performed. Metrics of ventilation & perfusion volume overlap btwn time points estimated using Dice coefficient.

  • Change in ventilation in lung tissue, assessed using 99mTc-DTPA SPECT/CT [ Time Frame: Baseline to up to 3 months post-treatment ] [ Designated as safety issue: No ]
    Image sets from all time points fused using rigid registration. Regions of interest defined using automated & semi-automated methods, incl. simple thresholds & gradient-search algorithms. Each tracer's uptake value calculated for each voxel. For lung tissue outside radiation field, summary statistics (total regional uptake & mean regional uptake by lobe) compared across time points w/parametric & non-parametric testing. Voxel-based correlation, incl. Pearson linear & Spearman rank, performed. Metrics of ventilation & perfusion volume overlap btwn time points estimated using Dice coefficient.


Secondary Outcome Measures:
  • Changes in tracer uptake at the global lung, regional lung, and lung image voxel scales, assessed using 99mTc-MAA and 99mTc-DTPA SPECT/CT [ Time Frame: Baseline to up to 3 months post-treatment ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Functional lung sparing for proton radiation therapy [ Time Frame: Up to 3 months post-treatment ] [ Designated as safety issue: No ]
    Comparison planning with proton radiation will be performed. Two planning paradigms will be utilized: (1) fixed tumor dose objectives and comparison of normal tissue dose sparing, (2) fixed normal tissue objectives and comparison of tumor dose escalation.

  • FDG PET avid regions of functionally viable disease [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Under the second paradigm, tumor dose escalation will be planned to uniformly cover the anatomic disease extent or to differentially cover FDG PET avid regions of functionally viable disease.


Estimated Enrollment: 20
Study Start Date: January 2014
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Radiation: technetium Tc 99m-labeled macroaggregated albumin
Undergo 99mTc-MAA SPECT/CT
Other Names:
  • (99m)Tc-labeled MAA
  • (99m)Tc-labeled macroaggregated albumin
  • Tc 99m-labeled MAA
  • Tc 99m-labeled macroaggregated albumin
  • technetium-99m-labeled albumin macroaggregates
Drug: technetium Tc 99m DTPA
Undergo 99mTc-DTPA SPECT/CT
Other Names:
  • 99m-technetium diethylenetriaminepentaacetic acid
  • Tc-99m-DTPA
  • Tc-DTPA
Procedure: single photon emission computed tomography
Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT
Other Names:
  • SPECT imaging
  • tomography, emission computed, single photon
Procedure: computed tomography
Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT
Other Name: tomography, computed
Radiation: fludeoxyglucose F 18
Undergo 18F FDG PET/CT
Other Names:
  • 18FDG
  • FDG
Procedure: positron emission tomography
Undergo 18F FDG PET/CT
Other Names:
  • FDG-PET
  • PET
  • PET scan
  • tomography, emission computed
Procedure: computed tomography
Undergo 18F FDG PET/CT
Other Name: tomography, computed

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01982123

Locations
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Jing Zeng    206-598-4100      
Principal Investigator: Jing Zeng         
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Jing Zeng Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT01982123     History of Changes
Other Study ID Numbers: 8180, NCI-2013-01774, 8180, P30CA015704
Study First Received: October 22, 2013
Last Updated: August 29, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Edetic Acid
Fluorodeoxyglucose F18
Pentetic Acid
Technetium Tc 99m Aggregated Albumin
Technetium Tc 99m Pentetate
Anticoagulants
Antidotes
Chelating Agents
Diagnostic Uses of Chemicals
Hematologic Agents
Iron Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Radiopharmaceuticals
Sequestering Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014