A Prospective Clinical Study on the Safety and Efficacy of Radiofrequency Ablation for the Treatment of Patients With Desmoid Tumors

NCT ID: NCT06355921

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2028-05-01

Brief 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.

Conditions

Desmoid Tumor; Desmoid Fibromatosis; Desmoid

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Desmoid

Adult patients with desmoid tumors in the soft tissues of the extremities, trunk and paravertebral region of both sexes.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.

Group Type: EXPERIMENTAL

radiofrequency ablation

Intervention Type: PROCEDURE

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.

Interventions

radiofrequency ablation

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Blokhin's Russian Cancer Research Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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)

Moscow, Moscow Oblast, Russia

Countries

Russia

Central Contacts

Artem Galustov

Role: CONTACT

artem115583@mail.ru

9169117818

Facility Contacts

Artem Galustov

Role: primary

artem115583@mail.ru

9169117818

Other Identifiers

RFAdesmoid

Identifier Type: -

Identifier Source: org_study_id