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

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Basic Trial Information

PhaseTypeStatusAgeTrial IDs
No phase specifiedDiagnosticActive19 and over8180
NCI-2013-01774, NCT01982123

Trial Description

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. Diagnostic procedures that measure lung function may help doctors find healthy lung tissue and allow them to plan better treatment.

Further Study Information

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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

University of Washington Medical Center

  • National Cancer Institute
Jing Zeng, Principal Investigator

Trial Sites

U.S.A.

Washington
Seattle

Fred Hutch/University of Washington Cancer Consortium

Jing Zeng
Ph: 206-598-4100
Email: jzeng13@uw.edu

Jing Zeng
Principal Investigator

ProCure Proton Therapy Center-Seattle

Jing Zeng
Ph: 206-598-4100
Email: jzeng13@uw.edu

Jing Zeng
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01982123

Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.