This phase I clinical trial studies image-guided cryosurgery in treating patients with head, neck, and spine tumors. Cryoablation, also known as cryosurgery, is a procedure in which an extremely cold liquid or an instrument called a cryoprobe is used to freeze and destroy abnormal tissue. Cryoablation may shrink the tumor, reduce pain, and improve quality of life in patients with head, neck, and spine tumors.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02085941.
PRIMARY OBJECTIVES:
I. Assess the safety and feasibility of real-time image guidance for the percutaneous cryoablation of malignancies in patients with unresectable or untreatable head, neck and spine tumors.
SECONDARY OBJECTIVES:
I. 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.
II. Document adverse events via Common Terminology Criteria for Adverse Events (CTCAE) version (vs.) 4.
III. Assess quality of life and pain via the patient self-report University of Washington Quality of Life Questionnaire (UW-QOL).
OUTLINE: Patients are assigned to 1 of 2 treatment arms.
ARM I: Patients undergo 3T-magnetic resonance imaging (MRI) scan followed by cryosurgery.
ARM II: Patients undergo whole-body fludeoxyglucose F 18 (FDG) positron emission tomography (PET)/computed tomography (CT) scan followed by cryosurgery.
After completion of study treatment, patients are followed up at 1, 3, and 6 months.
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorThomas C Lee
