Trial Outcomes & Findings for Same-session MR-only Simulation and Treatment With MRI-guided Adaptive Palliative RadioTherapy (NCT NCT03824366)

NCT ID: NCT03824366

Last Updated: 2025-01-10

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: Completion of enrollment (approximately 29 months)
• Results posted on: 2025-01-10

Participant Flow

Patients would be considered evaluable for the study if they were able to be scheduled for radiation treatment per protocol.

Participant milestones

Measure	Volumetric MR Imaging Planning * All patients will undergo volumetric MR imaging on treatment days in positioning appropriate for the specific treatment site. * Patients will receive standard of care palliative radiation therapy
Overall Study STARTED	20
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Volumetric MR Imaging Planning * All patients will undergo volumetric MR imaging on treatment days in positioning appropriate for the specific treatment site. * Patients will receive standard of care palliative radiation therapy
Overall Study Death	1
Overall Study Previously unidentified metal artifact	1
Overall Study Unable to tolerate lying flat on MR table	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Same-session MR-only Simulation and Treatment With MRI-guided Adaptive Palliative RadioTherapy

Baseline characteristics by cohort

Measure	Volumetric MR Imaging Planning n=20 Participants * All patients will undergo volumetric MR imaging on treatment days in positioning appropriate for the specific treatment site. * Patients will receive standard of care palliative radiation therapy
Age, Continuous	66 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 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	3 Participants n=5 Participants
Race (NIH/OMB) White	16 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	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Completion of enrollment (approximately 29 months)

Outcome measures

Measure	Volumetric MR Imaging Planning n=16 Participants * All patients will undergo volumetric MR imaging on treatment days in positioning appropriate for the specific treatment site. * Patients will receive standard of care palliative radiation therapy
Feasibility of Same-session MRI-only Simulation as Defined as More Than 70% of Patients Receiving at Least 70% of Their Scheduled Treatment Fractions on the First On-table Attempt for Each Respective Fraction.	16 Participants

Adverse Events

Volumetric MR Imaging Planning

Serious events: 2 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Measure	Volumetric MR Imaging Planning n=16 participants at risk * All patients will undergo volumetric MR imaging on treatment days in positioning appropriate for the specific treatment site. * Patients will receive standard of care palliative radiation therapy
Gastrointestinal disorders Abdominal pain	6.2% 1/16 • Adverse events and all-cause mortality were tracked through 1 week following the last day of MRgRT, an average of 2 weeks.
Gastrointestinal disorders Constipation	6.2% 1/16 • Adverse events and all-cause mortality were tracked through 1 week following the last day of MRgRT, an average of 2 weeks.
Respiratory, thoracic and mediastinal disorders Cough	6.2% 1/16 • Adverse events and all-cause mortality were tracked through 1 week following the last day of MRgRT, an average of 2 weeks.
Respiratory, thoracic and mediastinal disorders Dyspnea	6.2% 1/16 • Adverse events and all-cause mortality were tracked through 1 week following the last day of MRgRT, an average of 2 weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death due to disease	6.2% 1/16 • Adverse events and all-cause mortality were tracked through 1 week following the last day of MRgRT, an average of 2 weeks.

Other adverse events

Measure	Volumetric MR Imaging Planning n=16 participants at risk * All patients will undergo volumetric MR imaging on treatment days in positioning appropriate for the specific treatment site. * Patients will receive standard of care palliative radiation therapy
Gastrointestinal disorders Abdominal pain	6.2% 1/16 • Adverse events and all-cause mortality were tracked through 1 week following the last day of MRgRT, an average of 2 weeks.
Gastrointestinal disorders Diarrhea	6.2% 1/16 • Adverse events and all-cause mortality were tracked through 1 week following the last day of MRgRT, an average of 2 weeks.
General disorders Non-cardiac chest pain	6.2% 1/16 • Adverse events and all-cause mortality were tracked through 1 week following the last day of MRgRT, an average of 2 weeks.
Metabolism and nutrition disorders Anorexia	6.2% 1/16 • Adverse events and all-cause mortality were tracked through 1 week following the last day of MRgRT, an average of 2 weeks.
Musculoskeletal and connective tissue disorders Back pain	12.5% 2/16 • Adverse events and all-cause mortality were tracked through 1 week following the last day of MRgRT, an average of 2 weeks.
Musculoskeletal and connective tissue disorders Myalgia	6.2% 1/16 • Adverse events and all-cause mortality were tracked through 1 week following the last day of MRgRT, an average of 2 weeks.
General disorders Fatigue	6.2% 1/16 • Adverse events and all-cause mortality were tracked through 1 week following the last day of MRgRT, an average of 2 weeks.
Gastrointestinal disorders Nausea	6.2% 1/16 • Adverse events and all-cause mortality were tracked through 1 week following the last day of MRgRT, an average of 2 weeks.

Additional Information

Hyun Kim, M.D.

Washington University School of Medicine

Phone: 314-362-8502

Email: kim.hyun@wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place