Image-guided Cryoablation of Head, Neck and Spine Tumors

NCT02085941 | Completed Results DMC

• 1 other identifier: 13-458
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Head and Neck Neoplasms; Malignant Neoplasm of Vertebral Column

Keywords

Head and Neck Neoplasms; Malignant Neoplasm of Vertebral Column

Outcome Measures

Primary Outcomes (1)

• Number of Participants Undergoing Image-guided Cryoablation of a Head, Neck, or Spine Tumor With Adverse Events

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

  One month

Secondary Outcomes (2)

• Progression Rates

  6 months

• Pain Assessment

  6 months

Study Arms (2)

MRI guided cryoablation +/- biopsy

EXPERIMENTAL

Intraoperative MRI guidance for cryoablation of tumor using 17G Galil cryoprobe with concurrent biopsy with 18G Temno core biopsy needle if biopsy not previously performed

Device: Cryoablation; Device: Biopsy

PET-CT guided cryoablation +/- biopsy

EXPERIMENTAL

Intraoperative PET-CT guidance for cryoablation of tumor using 17G Galil cryoprobe with concurrent biopsy with 18G Temno core biopsy needle if biopsy not previously performed

Device: Cryoablation; Device: Biopsy

Interventions

Cryoablation DEVICE

Cryoablation using 17G Galil cryoprobe

MRI guided cryoablation +/- biopsy; PET-CT guided cryoablation +/- biopsy

Biopsy DEVICE

Biopsy using 18G Temno core biopsy needle

MRI guided cryoablation +/- biopsy; PET-CT guided cryoablation +/- biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Leukocytes ≥ 3,000/microliter (mcL)
• Absolute neutrophil count ≥ 1,500/mcL
• Platelets ≥ 100,000/microliter (mcL)
• Total bilirubin within normal institutional limits
• Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) ≤ 2.5 X institutional upper limit of normal

You may not qualify if:

• 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.
• 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.
• Based on potential risks of fetal loss, teratogenicity, fetal growth retardation and carcinogenesis, PET/CT is contraindicated in the pregnant patient.
• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Spinal Cord Neoplasms

Interventions

Cryosurgery; Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Investigative Techniques

Results Point of Contact

• Title: Thomas C. Lee, MD
• Organization: Brigham & Women's Hospital/Dana-Farber Cancer Institute

tchlee@bwh.harvard.edu

617-732-7260

Study Officials

• Thomas Lee, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 13, 2014
• Study Start: February 1, 2015
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: August 15, 2022
• Results First Posted: August 15, 2022

Record last verified: 2022-07

Locations

US (2)