N/A
N=12
SPECT/CT in Measuring Lung Function in Patients With Cancer Undergoing Radiation Therapy
Lung Carcinoma · Malignant Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT01982123 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: Spatial Stability of Lung Perfusion and Ventilation Over Time, as Assessed Using 99mTc-MAA SPECT/CT — 0.95 correlation coefficient
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SPECT/CT (Diagnostic_test); Single Photon Emission Computed Tomography (Procedure); Technetium Tc-99m Albumin Aggregated (Radiation); Technetium Tc-99m DTPA (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Spatial Stability of Lung Perfusion and Ventilation Over Time, as Assessed Using 99mTc-MAA SPECT/CT |
0.95 | — |
| SECONDARY Radiation Dose With 50% Decrease in Lung Perfusion, Assessed Using 99mTc-MAA and 99mTc-DTPA SPECT/CT |
21 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01982123). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.