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

University of Washington

Status

Completed

Conditions

Malignant Neoplasm

Lung Carcinoma

Treatments

Diagnostic Test: SPECT/CT

Drug: Technetium Tc-99m DTPA

Radiation: Technetium Tc-99m Albumin Aggregated

Procedure: Single Photon Emission Computed Tomography

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01982123

NCI-2013-01774 (Registry Identifier)

8180 (Other Identifier)

P30CA015704 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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