About this trial
This is a prospective study on the safety and effectiveness of radiofrequency ablation in patients with desmoid tumors.
In the study group, all patients after radiofrequency ablation of the tumor after 1 month will be evaluated using MRI and CT studies and, if solid components of the tumor are detected, repeated surgical treatment is performed followed by active monitoring after 1 month.
In the absence of a solid component, the effect is estimated by the volume of the necrotic process and monitored in dynamics every 3 months.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients with histologically verified diagnosis of dermoid tumor
The presence of progressive, symptomatic or functionally significant DF.
Written Informed consent to participate in the study
Age from 18 to 75 years
Disqualifiers
The inability to obtain informed consent to participate in the study
Synchronous or metachronous cancer
Clinically significant diseases of the cardiovascular system
Clinically significant CNS diseases
Trial design
Single group
Treatments tested in this trial
radiofrequency ablation
Procedure/SurgeryAnesthesia: Local (Novocaine, Lidocaine, Bupivacaine) Access: transcutaneous Navigation under CT control Cannulas are used: 22G 100 and 150 mm, the size of the electrode corresponds to the size of the cannula The starting power is 20W followed by steps of 10W every 2 minutes until the maximum power is reached, the maximum power is 60W. In order to prevent infectious complications, two-day antibiotic prophylaxis of Cefazolin (1g) is carried out 3 times a day In order to prevent skin burns with superficially located DFS, the skin is cooled during the procedure.
Treatment groups
Trial outcomes
Primary outcomes
Comparison of safety assessment.
Adverse Event Assessment and Serious Adverse Event Assessment according to CTCAE 5.0
Secondary outcomes
Overall Response Rate
Proportion of patients who have a partial or complete response to therapy
Duration of responce
The time from randomization to disease progression or death for patients who achieve complete or partial alleviation
Comparison of tumor necrosis based on MRI/CT
Proportion of tumor necrosis after therapy
Locations
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Sponsors and contacts
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