Trial Outcomes & Findings for Image-guided Cryoablation of Head, Neck and Spine Tumors (NCT NCT02085941)

NCT ID: NCT02085941

Last Updated: 2022-08-15

Results Overview

Assess the number of adverse events from time of procedure to one month post-procedure.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: One month
• Results posted on: 2022-08-15

Participant Flow

Participant milestones

Measure	MRI Guided Cryoablation Participants had cryoablation monitored by intraoperative MRI guidance	PET-CT Guided Cryoablation Participants had cryoablation monitored by intraoperative PET-CT guidance
Overall Study STARTED	25	5
Overall Study COMPLETED	17	2
Overall Study NOT COMPLETED	8	3

Reasons for withdrawal

Measure	MRI Guided Cryoablation Participants had cryoablation monitored by intraoperative MRI guidance	PET-CT Guided Cryoablation Participants had cryoablation monitored by intraoperative PET-CT guidance
Overall Study Lack of Efficacy	1	0
Overall Study Death	6	1
Overall Study Lost to Follow-up	1	0
Overall Study Physician Decision	0	2

Baseline Characteristics

Image-guided Cryoablation of Head, Neck and Spine Tumors

Baseline characteristics by cohort

Measure	MRI Guided Cryoablation n=25 Participants Participants had tumors cryoablation by intraoperative MRI guidance	PET-CT Guided Cryoablation n=5 Participants Participants had tumors cryoablation by intraoperative PET-CT guidance	Total n=30 Participants Total of all reporting groups
Age, Continuous	56.2 years STANDARD_DEVIATION 11.6 • n=5 Participants	63.0 years STANDARD_DEVIATION 8.8 • n=7 Participants	57.1 years STANDARD_DEVIATION 13.1 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	2 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	3 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants	5 Participants n=7 Participants	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	5 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: One month

Assess the number of adverse events from time of procedure to one month post-procedure.

Outcome measures

Measure	MRI Guided Cryoablation n=25 Participants Participants had cryoablation monitored by intraoperative MRI guidance	PET-CT Guided Cryoablation n=5 Participants Participants had cryoablation monitored by intraoperative PET-CT guidance
Number of Participants Undergoing Image-guided Cryoablation of a Head, Neck, or Spine Tumor With Adverse Events	3 participants	0 participants

SECONDARY outcome

Timeframe: 6 months

Assess patient's local progression rates with the criteria proposed by the Interventional Radiology Technology Assessment Committee and the International Working Group on Image-Guided Tumor Ablation

Outcome measures

Measure	MRI Guided Cryoablation n=17 Participants Participants had cryoablation monitored by intraoperative MRI guidance	PET-CT Guided Cryoablation n=2 Participants Participants had cryoablation monitored by intraoperative PET-CT guidance
Progression Rates	39.4 percentage of tumor reduction Standard Deviation 54.4	100 percentage of tumor reduction Standard Deviation 0

SECONDARY outcome

Timeframe: 6 months

Assess patient's pain localized to the target of cryoablation with a 10-point Visual Analog Scale (VAS), specifically, pain was rated on a scale from 0 to 10 with 0 representing no pain and 10 representing the worst pain.

Outcome measures

Measure	MRI Guided Cryoablation n=17 Participants Participants had cryoablation monitored by intraoperative MRI guidance	PET-CT Guided Cryoablation n=2 Participants Participants had cryoablation monitored by intraoperative PET-CT guidance
Pain Assessment	2.6 score on a scale Standard Deviation 2.1	0 score on a scale Standard Deviation 0

Adverse Events

MRI Guided Cryoablation

Serious events: 0 serious events

Other events: 3 other events

Deaths: 6 deaths

PET-CT Guided Cryoablation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	MRI Guided Cryoablation n=25 participants at risk Participants had cryoablation monitored by intraoperative MRI guidance	PET-CT Guided Cryoablation n=5 participants at risk Participants had cryoablation monitored by intraoperative PET-CT guidance
Infections and infestations Neck abscess	4.0% 1/25 • Number of events 1 • 6 months	0.00% 0/5 • 6 months
Nervous system disorders Neuropathy	8.0% 2/25 • Number of events 2 • 6 months	0.00% 0/5 • 6 months

Additional Information

Thomas C. Lee, MD

Brigham & Women's Hospital/Dana-Farber Cancer Institute

Phone: 617-732-7260

Email: tchlee@bwh.harvard.edu

Results disclosure agreements

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