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N/A N=30 Treatment

Image-guided Cryoablation of Head, Neck and Spine Tumors

Head and Neck Neoplasms · Malignant Neoplasm of Vertebral Column

Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcome: Primary: Number of Participants Undergoing Image-guided Cryoablation of a Head, Neck, or Spine Tumor With Adverse Events — 3; 0 participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Cryoablation (Device); Biopsy (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Dana-Farber Cancer Institute
Primary completion
Jul 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants Undergoing Image-guided Cryoablation of a Head, Neck, or Spine Tumor With Adverse Events
3; 0
SECONDARY
Progression Rates
39.4; 100
SECONDARY
Pain Assessment
2.6; 0

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.

Eligibility 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 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
  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02085941). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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