Cryotherapy in the Treatment of Desmoid Tumors

July 29, 2025 updated by: Costantino Errani, Istituto Ortopedico Rizzoli
Desmoid tumor is a benign neoplasm with an unpredictable course and a high rate of local recurrence if treated surgically. Therefore, over time the surgical approach has become conservative, preferring simple observation or medical therapy in case of disease progression through the use of hormonal therapy and low-dose chemotherapy. Since this neoplasm remains benign, our study aims to avoid chemotherapy in patients usually young through the use of a minimally invasive treatment such as cryotherapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • BO
      • Bologna, BO, Italy, 40136
        • Recruiting
        • IRCCS Itituto Ortopedico Rizzoli
        • Contact:
          • Costantino Errani, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • histologic diagnosis of desmoid tumors
  • age > 18 years
  • abdominal and extra-abdominal desmoid tumors

Exclusion Criteria:

  • contraindication to the procedure by the interventional radiologist in terms of tumor proximity to neurologic/vascular structures
  • retroperitoneal desmoid tumors
  • age < 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients
Procedure: Cryotherapy
The procedure involves general or peripheral anesthesia and percutaneous treatment under CT control with probes capable of forming ice spheres of up to 3 cm that will be used in sufficient number to treat the neoplasm completely.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
response to treatment
Time Frame: At baseline (time 0)
assessment of tumor response to treatment will be performed using the solid tumor response criteria
At baseline (time 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Rizzoli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2021

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

October 12, 2021

First Submitted That Met QC Criteria

October 12, 2021

First Posted (Actual)

October 25, 2021

Study Record Updates

Last Update Posted (Actual)

August 1, 2025

Last Update Submitted That Met QC Criteria

July 29, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRYODESMO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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