Trial Outcomes & Findings for Feasibility Study of Enhanced MRI for Early Stage Non Small Cell Lung Cancer (NSCLC) (NCT NCT01799135)

Results Overview

Feasibility rate is defined as the number of participants with a 20% or greater change in tumor perfusion at 1-2 days, 1-2 weeks, and 3-4 months from baseline. Feasibility must be achieved at all 3 timepoints to be considered as a success. Perfusion measured using establish methods in conjunction with Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI)

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

Measured 1-2 days, 1-2 weeks, and 3-4 months from baseline.

Results posted on

2021-10-12

Participant Flow

November 2012 to August 2016

Participant milestones

Participant milestones
Measure	Experimental Arm Stereotactic Body Radiation Therapy: either 54 Gy in 3 fractions or 50-60 Gy in 5 fraction over a span of 15 days at most. DCE-MRI was performed at four time points during therapy: at baseline prior to SBRT, 1-2 days after the first treatment fraction, 1-2 weeks after the end of the SBRT course, and 3 months after completing radiotherapy. 4D-CT scan 3 months after completing radiotherapy. DCE-MRI scan Stereotactic Body Radiation Therapy 4D-CT scan
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility Study of Enhanced MRI for Early Stage Non Small Cell Lung Cancer (NSCLC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental Arm n=6 Participants Stereotactic Body Radiation Therapy: either 54 Gy in 3 fractions or 50-60 Gy in 5 fraction over a span of 15 days at most. DCE-MRI was performed at four time points during therapy: at baseline prior to SBRT, 1-2 days after the first treatment fraction, 1-2 weeks after the end of the SBRT course, and 3 months after completing radiotherapy. 4D-CT scan 3 months after completing radiotherapy. DCE-MRI scan Stereotactic Body Radiation Therapy 4D-CT scan
Age, Continuous	67.5 year n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	1 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Measured 1-2 days, 1-2 weeks, and 3-4 months from baseline.

Feasibility rate is defined as the number of participants with a 20% or greater change in tumor perfusion at 1-2 days, 1-2 weeks, and 3-4 months from baseline. Feasibility must be achieved at all 3 timepoints to be considered as a success. Perfusion measured using establish methods in conjunction with Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI)

Outcome measures

Outcome measures
Measure	Experimental Arm n=6 Participants Stereotactic Body Radiation Therapy: either 54 Gy in 3 fractions or 50-60 Gy in 5 fraction over a span of 15 days at most. DCE-MRI was performed at four time points during therapy: at baseline prior to SBRT, 1-2 days after the first treatment fraction, 1-2 weeks after the end of the SBRT course, and 3 months after completing radiotherapy. 4D-CT scan 3 months after completing radiotherapy. DCE-MRI scan Stereotactic Body Radiation Therapy 4D-CT scan
Feasibility Rate at 1-2 Days After the First SBRT Treatment and 1-2 Weeks and 3-4 Months After SBRT Treatment.	66.7 percentage of participants Interval 27.1 to 93.7

SECONDARY outcome

Timeframe: 3 months

Feasibility (success) is defined as successfully enrolling patients, processing the pulmonary DCE-MRI data, and observing at least a 20% change in perfusion on the 3-month scan.

Outcome measures

Outcome measures
Measure	Experimental Arm n=6 Participants Stereotactic Body Radiation Therapy: either 54 Gy in 3 fractions or 50-60 Gy in 5 fraction over a span of 15 days at most. DCE-MRI was performed at four time points during therapy: at baseline prior to SBRT, 1-2 days after the first treatment fraction, 1-2 weeks after the end of the SBRT course, and 3 months after completing radiotherapy. 4D-CT scan 3 months after completing radiotherapy. DCE-MRI scan Stereotactic Body Radiation Therapy 4D-CT scan
Feasibility Rate of Using Pulmonary DCE-MRI in Characterizing Acute and Subacute Radiation-induced Lung Injury	50 percentage of participants Interval 15.3 to 84.6

SECONDARY outcome

Timeframe: 3 months

Feasibility (success) is defined as successfully enrolling patients, processing the pulmonary DCE-MRI and 4D-CT data, and observing at least a 20% change in perfusion on the 3-month scan.

Outcome measures

Outcome measures
Measure	Experimental Arm n=6 Participants Stereotactic Body Radiation Therapy: either 54 Gy in 3 fractions or 50-60 Gy in 5 fraction over a span of 15 days at most. DCE-MRI was performed at four time points during therapy: at baseline prior to SBRT, 1-2 days after the first treatment fraction, 1-2 weeks after the end of the SBRT course, and 3 months after completing radiotherapy. 4D-CT scan 3 months after completing radiotherapy. DCE-MRI scan Stereotactic Body Radiation Therapy 4D-CT scan
Feasibility Rate of Using 4D-CT Ventilation Imaging With Pulmonary DCE-MRI in Characterizing Acute and Subacute Radiation Induced Lung Injury	0 percentage of participants Interval 0.0 to 39.3

SECONDARY outcome

Timeframe: 3 months

Feasibility will be defined as the ability to perform a retrospective comparative treatment planning study using the DCE-MRI images acquired prior to treatment for each participant. Regions of functional and non-functional lung will be defined on each MRI, and the images will be registered to the 4DCT used for treatment planning. The functional-lung contours will be transferred to the 4D-CT based on this registration. the treatment plan will attempt to maximize sparing of functional-lung regions while maintaining adequate target coverage and not exceeding other normal-tissue constraints. The functional-lung based treatment plans generated in this manner will be compared to the corresponding standard plans that were used to treat the patient. Changes in the functional-lung V20 and V5 will be used to analyze changes in functional-lung sparing

Outcome measures

Outcome measures
Measure	Experimental Arm n=6 Participants Stereotactic Body Radiation Therapy: either 54 Gy in 3 fractions or 50-60 Gy in 5 fraction over a span of 15 days at most. DCE-MRI was performed at four time points during therapy: at baseline prior to SBRT, 1-2 days after the first treatment fraction, 1-2 weeks after the end of the SBRT course, and 3 months after completing radiotherapy. 4D-CT scan 3 months after completing radiotherapy. DCE-MRI scan Stereotactic Body Radiation Therapy 4D-CT scan
Feasibility Rate of Using Pulmonary DCE-MRI to Identify Regions of Functional Lung for SBRT Treatment Planning	83.3 percentage of participants Interval 41.8 to 99.1

Adverse Events

Experimental Arm

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Experimental Arm n=6 participants at risk Stereotactic Body Radiation Therapy: either 54 Gy in 3 fractions or 50-60 Gy in 5 fraction over a span of 15 days at most. DCE-MRI was performed at four time points during therapy: at baseline prior to SBRT, 1-2 days after the first treatment fraction, 1-2 weeks after the end of the SBRT course, and 3 months after completing radiotherapy. 4D-CT scan 3 months after completing radiotherapy. DCE-MRI scan Stereotactic Body Radiation Therapy 4D-CT scan
General disorders Death NOS	16.7% 1/6 • Up to 4 months Serious Adverse Events (SAE's) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term

Other adverse events

Other adverse events
Measure	Experimental Arm n=6 participants at risk Stereotactic Body Radiation Therapy: either 54 Gy in 3 fractions or 50-60 Gy in 5 fraction over a span of 15 days at most. DCE-MRI was performed at four time points during therapy: at baseline prior to SBRT, 1-2 days after the first treatment fraction, 1-2 weeks after the end of the SBRT course, and 3 months after completing radiotherapy. 4D-CT scan 3 months after completing radiotherapy. DCE-MRI scan Stereotactic Body Radiation Therapy 4D-CT scan
Vascular disorders Hypertension	16.7% 1/6 • Number of events 1 • Up to 4 months Serious Adverse Events (SAE's) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term
Infections and infestations Lung Infection	16.7% 1/6 • Number of events 1 • Up to 4 months Serious Adverse Events (SAE's) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term

Additional Information

Raymond H. Mak

Dana Farber Cancer Institute

Phone: 617.632.3591

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place