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NCT Number: NCT06355921

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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, 115522, Russia

Location contact

Artem Galustov

CONTACT

[email protected]

9169117818

Aslan Valiev, PhD

PRINCIPAL_INVESTIGATOR

Denis Sofronov, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • The functional status of the patient according to the ECOG 0-2 scale
  • Normal renal function (estimated creatinine clearance 60 ml/min);
  • Normal level of bilirubin and liver enzymes (AST, ALT - no more than 3 norms);
  • Left ventricular ejection fraction > 55%
  • Satisfactory bone marrow function (hemoglobin level 9 g/dl, neutrophil count 1.5 thousand/ml, platelet count < 100 thousand/ml);

Exclusion criteria

  • 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
  • Previous grade 2 polyneuropathy and above
  • Current infection or other severe or systemic disease that increases the risk of complications of therapy
  • Pregnancy, lactation

Treatment and study plan

Radiofrequency ablation

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.

Primary outcomes

  1. Comparison of safety assessment.

    Time frame: The effectiveness of treatment is monitored 1 month after treatment, then every 3 months for 2 years, every 6 months from 2 to 3 years from the moment of therapy

    Adverse Event Assessment and Serious Adverse Event Assessment according to CTCAE 5.0

Secondary outcomes

  1. Overall Response Rate

    Time frame: The effectiveness of treatment is monitored 1 month after treatment, then every 3 months for 2 years, every 6 months from 2 to 3 years from the moment of therapy

    Proportion of patients who have a partial or complete response to therapy

  2. Duration of responce

    Time frame: 3 years

    The time from randomization to disease progression or death for patients who achieve complete or partial alleviation

  3. Comparison of tumor necrosis based on MRI/CT

    Time frame: The effectiveness of treatment is monitored 1 month after treatment, then every 3 months for 2 years, every 6 months from 2 to 3 years from the moment of therapy

    Proportion of tumor necrosis after therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Artem Galustov

CONTACT

[email protected]

9169117818

Sponsors and collaborators

Lead sponsor

Blokhin's Russian Cancer Research Center

Other

Registry information

Acronym: RFAdesmoid

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Apr 10, 2024
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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