Trial Outcomes & Findings for Dynamic Magnetic Resonance Imaging (MRI) for Lung Tumor Motion and Lung Function (GCC 0943) (NCT NCT01016938)

Results Overview

Tumor tracking using cine-MRI and external surrogates with an accuracy of \~ 2mm. The participants' tumor size/margins were not specficially defined as long as it was visible/measurable on the MRI.

Recruitment status

COMPLETED

Target enrollment

16 participants

Primary outcome timeframe

2 years

Results posted on

2019-08-19

Participant Flow

Participant milestones

Participant milestones
Measure	Dynamic Lung MRI Lung Tumor Motion and Function
Overall Study STARTED	16
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dynamic Magnetic Resonance Imaging (MRI) for Lung Tumor Motion and Lung Function (GCC 0943)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dynmaic Lung MRI n=16 Participants Lung Tumor Motion and Function
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Tumor tracking using cine-MRI and external surrogates with an accuracy of \~ 2mm. The participants' tumor size/margins were not specficially defined as long as it was visible/measurable on the MRI.

Outcome measures

Outcome measures
Measure	Lung Tumor Motion and Lung Function n=16 Participants This is a pilot study and there is only one group.
Number of Participants Whose Tumor Position is Visible Within ~2mm Using Cine-MRI Scans and External Sensors	7 participants

SECONDARY outcome

Timeframe: 2 years

The internal margin (IM) is one half of the peak-to-peak displacement amplitude on 4D-CT images.

Outcome measures

Outcome measures
Measure	Lung Tumor Motion and Lung Function n=16 Participants This is a pilot study and there is only one group.
Number of Participants Whose Tumor Motion Could be Tracked Using Dynamic MRI w/ Contrast Post Radiation	7 participants

Adverse Events

Dynamic Lung MRI

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

Warren D'Souza, PhD, MBA

Universtity of Maryland School of Medicine

Phone: 410-328-7159

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place