Image-guided Cryoablation of Head, Neck and Spine Tumors
Phase: NA
Conditions: Head and Neck Neoplasms, Malignant Neoplasm of Vertebral Column
Sponsor: Dana-Farber Cancer Institute

Image-guided Cryoablation of Head, Neck and Spine Tumors 
 
NCT02085941 
 
June 21, 2022 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Protocol 
 
 
Brief Summary: 
This research study is evaluating a procedure called cryoablation (the removal of diseased tissue using 
extreme freezing temperatures) as a possible treatment for head, neck and spine tumors. 
 
Detailed Description: 
The participant will be assigned to either group 1 for MRI-guided cryoablation or group 2 for 
PET/CT guided cryoablation. Each participant's placement will be made by a team of radiologists, 
medical oncologists, surgical oncologists, and radiation oncologists. 
After the eligibility screening 
Group 1: 
The investigators will assess the participant's tumor by Magnetic Resonance Imaging (MRI). This is 
a safe and standard exam that will show the physician where the participant's tumor is located. 
MRI scans typically take 60 minutes. The investigator will ask the participant to complete a 
"Quality of Life" questionnaire. 
Following the participant's baseline scan, the physician will schedule the participant's procedure 
in the Advanced Multimodality Image-Guided Operating (AMIGO) suite. The participant will be 
placed under general anesthesia for the procedure. A cryoablation needle will be inserted 
through the skin and into the tumor using MRI guidance. The tip of the cryoablation needle forms 
an iceball which will be used to ablate the tumor cells. 
The physician will be able to see the tumor during the procedure through the MRI scan. The 
procedure will take about 3 hours, and the participant will be spending approximately 2 hours in 
the post-treatment anesthesia care unit. The participant will spend the subsequent night in the 
hospital, and will be discharged the next day. 
The investigators will ask that the participant to return 1 month, 3 months and 6 months post 
procedure. The participant will be asked to complete the Quality of Life questionnaire at the 1, 3 
and 6 month follow up visits. 
Group 2: 
The investigators will assess the participant's tumor by a Positron Emission Tomography (PET) 
scan and Computerized Tomography (CT). These are safe and standard exams that will show the 
physician where the participant's tumor is located. PET/CT scans typically take 60 minutes. The 
investigator will ask the participant to complete a "Quality of Life" questionnaire. 
Following the participant's baseline scan, the physician will schedule the participant's procedure 
in the AMIGO suite. The participant will be placed under general anesthesia for the procedure. A 
cryoablation needle will be inserted through the skin and into the tumor using PET/CT guidance. 
The tip of the cryoablation needle forms an iceball which will be used to ablate the tumor cells. 
The physician will be able to see the tumor during the procedure through the PET/CT scan. The 
procedure will take about 3 hours, and the participant will spend approximately 2 hours in the 

post-treatment anesthesia care unit. The participant will spend the subsequent night in the 
hospital, and will be discharged the next day. 
The investigators ask that the participant return 1 month, 3 months and 6 months post 
procedure. The participant will be asked to complete the Quality of Life questionnaire at the 1, 3 
and 6 month follow up visits. 
 
 
Study Design 
Study Type  : 
Interventional  (Clinical Trial) 
Actual Enrollment  : 
30 participants 
Allocation: 
N/A 
Intervention Model: 
Single Group Assignment 
Masking: 
None (Open Label) 
Primary Purpose: 
Treatment 
Official Title: 
Image-guided Cryoablation of Head, Neck and Spine Tumors 
Study Start Date  : 
February 2015 
Actual Primary Completion Date  : 
July 2021 
Actual Study Completion Date  : 
July 2021 
 
Arms and Interventions 
 
Arm  
Experimental: Image-guided cryoablation +/- biopsy 
• MRI/PET/CT imaging in the Advanced Multimodality Image Guided Operating (AMIGO) suite used to place
cryoablation needle(s) into target lesion (Mean: 3 cryoprobes, Range: 1-10). 
• MR/PET/CT imaging in the AMIGO suite will monitor two 15-minute freeze cycles separated by a 10 minut
thaw period. 

Arm  
 
 
Outcome Measures 
 
Primary Outcome Measures  : 
1. Number of participants undergoing image-guided cryoablation of a head, neck, or spine 
tumor with adverse events [ Time Frame: One month ] 
Assess the number of adverse events from time of procedure to one month post-
procedure. 
Secondary Outcome Measures  : 
1. Progression Rates [ Time Frame: 2 Years ] 
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 
 
2. QOL Assessment [ Time Frame: 2 Years ] 
Assess quality of life and pain via the patient self report University of Washington 
Quality of Life Questionnaire (UW-QOL) 
 
3. Pain assessment [ Time Frame: 2 years ] 
Assess patient's pain localized to the target of cryoablation with a 10-point Visual 
Analog Scale (VAS). 

 
 
Eligibility Criteria 
Ages Eligible for Study:   
18 Years and older   (Adult, Older Adult) 
Sexes Eligible for Study:   
All 
 Accepts Healthy Volunteers:   
No 
Criteria 
Inclusion Criteria: 
• 
Participants must meet the following criteria on screening examination to be eligible 
to participate in the study: 
• 
Participants must have histologically confirmed malignant tumor that is metastatic 
or unresectable and for which standard curative or palliative measures do not exist 
or are no longer effective. 
• 
Participants with malignant locally recurrent and/or metastatic tumors will be 
eligible for cryoablation. All tumor shapes and sizes will be eligible for ablation. 
• 
Participants must have sustained all available treatment options (radiation, 
chemotherapy, surgery) as verified by the Dana Farber Cancer Institute's Head and 
Neck Tumor Board. These cases will be reviewed by a team of medical oncologists, 
radiologists, radiation oncologists, and surgical oncologists. 
• 
Participants must have an advanced head, neck or spine malignant tumor that would 
potentially benefit from a minimally invasive procedure. 
• 
Age 18 years or older 
-- Because no dosing or adverse event data are currently available on the use of 
cryoablation in participants < 18 years of age, children are excluded from this study 
but will be eligible for future pediatric III trials. 
• 
Life expectancy of greater than 8 weeks in the opinion of the referring clinician. 
• 
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (see Appendix 
A). 
• 
Participants must have normal organ and marrow function as defined below: 
o 
Leukocytes ≥ 3,000/microliter (mcL) 
o 
Absolute neutrophil count ≥ 1,500/mcL 
o 
Platelets ≥ 100,000/microliter (mcL) 
o 
Total bilirubin within normal institutional limits 
o 
Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) ≤ 2.5 X 
institutional upper limit of normal 

o 
Creatinine within normal institutional limits or creatinine clearance ≥ 60 
mL/min/1.73 m2 for subjects with creatinine levels about institutional 
normal . 
• 
Cryoablation can be performed near vessels of the head and neck, and if deemed 
necessary tumor may be displaced using a saline injection (hydro-displacement). 
Tumor displacement from nerves may be required and will be performed as deemed 
appropriate to avoid nerve injury. 
• 
The effects of cryoablation on the developing human fetus are unknown. For this 
reason women of child-bearing potential and men must agree to use adequate 
contraception (hormonal or barrier method of birth control; abstinence) prior to 
study entry and for the duration of study participation. Should a woman become 
pregnant or suspect she is pregnant while participating in this study, she should 
inform her treating physician immediately. 
• 
Ability to understand and the willingness to sign a written informed consent 
document. 
• 
MRI-Guided Cryoablation Criteria-Cohort 1 
-- Participants must have a mass that is well-visualized under MRI. Since positron 
emission tomography-computed tomography (PET-CT) guidance requires the 
nuclear medicine department to administer a radionuclide material, the default will 
be to try to use MRI guidance. 
• 
PET/CT-Guided Cryoablation Criteria-Cohort 2 -- Patients must have a mass that is 
well visualized under PET/CT. Tumors that are not clearly seen by MRI but showing 
on PET/CT will be ablated with PET/CT guidance. 
Exclusion Criteria: 
• 
Participants who exhibit any of the following conditions at screening will not be 
eligible for admission into the study. 
• 
Participants with tumors involving the optic chiasm, brain, or spinal cord will not be 
eligible for participation in this study. Furthermore, tumors that encase any major 
blood vessel (carotid, jugular, vertebral) will be excluded from the study due to 
inability to displace these masses. 
• 
Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks 
for nitrosoureas or mitomycin C) prior to entering the study or those who have not 
recovered from adverse events due to agents administered more than 4 weeks 
earlier. 
• 
Participants may not be receiving any other study agents. 
• 
Participants with known brain metastases should be excluded from this clinical trial 
because of their poor prognosis and because they often develop progressive 
neurologic dysfunction that would confound the evaluation of neurologic and other 
adverse events. 

• 
History of allergic reactions attributed to compounds of similar chemical or biologic 
composition to gadolinium contrast agents, if contrast use is anticipated during the 
procedure. 
• 
Participants with a blood glucose level of > 200mg/dl prior to the baseline study, 
known ischemic disease, and/or impaired renal function (eGFR < 60ml/min) will not 
be eligible for this study. 
• 
Uncontrolled intercurrent illness including, but not limited to ongoing or active 
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac 
arrhythmia, or psychiatric illness/social situations that would limit compliance with 
study requirements. 
• 
Pregnant women are excluded from this study because gadolinium is a contrast 
agent with the potential for teratogenic or abortifacient effects. Because there is an 
unknown but potential risk of adverse events in nursing infants secondary to 
treatment of the mother with gadolinium, breastfeeding should be discontinued if 
the mother is treated with gadolinium. 
• 
MRI-Guided Cryoablation Exclusion Criteria-Cohort 1 
• 
-Pregnant women are excluded from this study because gadolinium is a contrast 
agent with the potential for teratogenic or abortifacient effects. Because there is an 
unknown but potential risk of adverse events in nursing infants secondary to 
treatment of the mother with gadolinium, breastfeeding should be discontinued if 
the mother is treated with gadolinium. 
• 
PET/CT-Guided Cryoablation Exclusion Criteria-Cohort 2 
o 
Based on potential risks of fetal loss, teratogenicity, fetal growth retardation 
and carcinogenesis, PET/CT is contraindicated in the pregnant patient. 
o 
Pregnant women are excluded from this study because PET/CT utilizes a 
radioactive diagnostic agent with the potential for teratogenic or 
abortifacient effects. Because there is an unknown but potential risk of 
adverse events in nursing infants secondary to treatment of the mother with 
a radionclide, breastfeeding should be discontinued if the mother is treated. 
 
 
 
Statistical Analysis Plan 
 
Tumor size at baseline, 1 month post, 3 months post and 6 months post as well as 
pain on a VAS scale from 1 to 10 at the same time points will be statistically 
analyzed by the Student’s t test analysis for significant reduction (p<0.05) 
comparing MRI guided ablation versus PET-CT guided ablation.