Trial Outcomes & Findings for SPECT/CT in Measuring Lung Function in Patients With Cancer Undergoing Radiation Therapy (NCT NCT01982123)

NCT ID: NCT01982123

Last Updated: 2018-12-13

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

12 participants

Primary outcome timeframe

Baseline to up to 3 months post-treatment

Results posted on

2018-12-13

Participant Flow

Participant milestones

Participant milestones
Measure	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. Computed Tomography: Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT Computed Tomography: Undergo 18F FDG PET/CT Fludeoxyglucose F-18: Undergo 18F FDG PET/CT Positron Emission Tomography: Undergo 18F FDG PET/CT Single Photon Emission Computed Tomography: Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT Technetium Tc-99m Albumin Aggregated: Undergo 99mTc-MAA SPECT/CT Technetium Tc-99m DTPA: Undergo 99mTc-DTPA SPECT/CT
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diagnostic (99mTc-MAA and 99mTc-DTPA SPECT/CT) n=12 Participants 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. Computed Tomography: Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT Computed Tomography: Undergo 18F FDG PET/CT Fludeoxyglucose F-18: Undergo 18F FDG PET/CT Positron Emission Tomography: Undergo 18F FDG PET/CT Single Photon Emission Computed Tomography: Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT Technetium Tc-99m Albumin Aggregated: Undergo 99mTc-MAA SPECT/CT Technetium Tc-99m DTPA: Undergo 99mTc-DTPA SPECT/CT
Age, Continuous	69.3 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	12 Participants n=5 Participants
Correlation between perfusion and ventilation on SPECT/CT scans pre-RT	0.9 correlation coefficient n=5 Participants

PRIMARY outcome

Timeframe: Baseline to up to 3 months post-treatment

Outcome measures

Outcome measures
Measure	SPECT/CT Mid-& Post-RT n=12 Participants Investigational 99mTc-MAA and 99mTc-DTPA SPECT/CT mid-radiation therapy (up to 1 week post-treatment), and at 3-6 months post-treatment. SPECT/CT: Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT mid-radiation and post-radiation Single Photon Emission Computed Tomography: Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT Technetium Tc-99m Albumin Aggregated: Undergo 99mTc-MAA SPECT/CT Technetium Tc-99m DTPA: Undergo 99mTc-DTPA SPECT/CT
Spatial Stability of Lung Perfusion and Ventilation Over Time, as Assessed Using 99mTc-MAA SPECT/CT	0.95 correlation coefficient

SECONDARY outcome

Timeframe: Baseline to up to 3 months post-treatment

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.

Outcome measures

Outcome measures
Measure	SPECT/CT Mid-& Post-RT n=12 Participants Investigational 99mTc-MAA and 99mTc-DTPA SPECT/CT mid-radiation therapy (up to 1 week post-treatment), and at 3-6 months post-treatment. SPECT/CT: Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT mid-radiation and post-radiation Single Photon Emission Computed Tomography: Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT Technetium Tc-99m Albumin Aggregated: Undergo 99mTc-MAA SPECT/CT Technetium Tc-99m DTPA: Undergo 99mTc-DTPA SPECT/CT
Radiation Dose With 50% Decrease in Lung Perfusion, Assessed Using 99mTc-MAA and 99mTc-DTPA SPECT/CT	21 Gy Interval 2.0 to 31.0

Adverse Events

Diagnostic (99mTc-MAA and 99mTc-DTPA SPECT/CT)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jing Zeng

University of Washington Medical Center

Phone: 2065984110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place