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Trial Title:
A Prospective Clinical Study on the Safety and Efficacy of Radiofrequency Ablation for the Treatment of Patients With Desmoid Tumors
NCT ID:
NCT06355921
Condition:
Desmoid Tumor
Desmoid Fibromatosis
Desmoid
Conditions: Official terms:
Fibromatosis, Aggressive
Fibroma
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
radiofrequency ablation
Description:
Anesthesia: 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.
Arm group label:
Desmoid
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients with histologically verified diagnosis of dermoid tumor
2. The presence of progressive, symptomatic or functionally significant DF.
3. Written Informed consent to participate in the study
4. Age from 18 to 75 years
5. The functional status of the patient according to the ECOG 0-2 scale
6. Normal renal function (estimated creatinine clearance 60 ml/min);
7. Normal level of bilirubin and liver enzymes (AST, ALT - no more than 3 norms);
8. Left ventricular ejection fraction > 55%
9. Satisfactory bone marrow function (hemoglobin level 9 g/dl, neutrophil count 1.5
thousand/ml, platelet count < 100 thousand/ml);
Exclusion Criteria:
1. The inability to obtain informed consent to participate in the study
2. Synchronous or metachronous cancer
3. Clinically significant diseases of the cardiovascular system
4. Clinically significant CNS diseases
5. Previous grade 2 polyneuropathy and above
6. Current infection or other severe or systemic disease that increases the risk of
complications of therapy
7. Pregnancy, lactation
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Federal State Budgetary Institution "N.N. Blokhin National Medical Research Center of Oncology" оf the Ministry of Health of the Russian Federation (N.N. Blokhin NMRCO)
Address:
City:
Moscow
Zip:
115522
Country:
Russian Federation
Contact:
Last name:
Artem Galustov
Phone:
9169117818
Email:
artem115583@mail.ru
Investigator:
Last name:
Aslan Valiev, PhD
Email:
Principal Investigator
Investigator:
Last name:
Denis Sofronov, PhD
Email:
Sub-Investigator
Start date:
April 1, 2024
Completion date:
May 1, 2028
Lead sponsor:
Agency:
Blokhin's Russian Cancer Research Center
Agency class:
Other
Source:
Blokhin's Russian Cancer Research Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06355921
