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Cryotherapy in the Treatment of Desmoid Tumors

Primary Purpose

Desmoid

Status

Recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Cryotherapy

About this trial

This is an interventional treatment trial for Desmoid focused on measuring desmoid tumor; cryotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

IRCCS Itituto Ortopedico RizzoliRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients

Arm Description

Outcomes

Primary Outcome Measures

response to treatment

assessment of tumor response to treatment will be performed using the solid tumor response criteria

Secondary Outcome Measures

Full Information

NCT ID

NCT05091255

First Posted

October 12, 2021

Last Updated

May 18, 2023

Sponsor

Istituto Ortopedico Rizzoli

1. Study Identification

Unique Protocol Identification Number

NCT05091255

Brief Title

Cryotherapy in the Treatment of Desmoid Tumors

Official Title

Cryotherapy in the Treatment of Desmoid Tumors

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 20, 2021 (Actual)

Primary Completion Date

January 1, 2027 (Anticipated)

Study Completion Date

January 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Istituto Ortopedico Rizzoli

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Desmoid

Keywords

desmoid tumor; cryotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Cryotherapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

response to treatment

Description

assessment of tumor response to treatment will be performed using the solid tumor response criteria

Time Frame

At baseline (time 0)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Costantino Errani, MD

Phone

051-6366

Ext

6103

costantino.errani@ior.it

Facility Information:

Facility Name

IRCCS Itituto Ortopedico Rizzoli

City

Bologna

State/Province

ZIP/Postal Code

40136

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Costantino Errani, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

19768644

Citation

Kujak JL, Liu PT, Johnson GB, Callstrom MR. Early experience with percutaneous cryoablation of extra-abdominal desmoid tumors. Skeletal Radiol. 2010 Feb;39(2):175-82. doi: 10.1007/s00256-009-0801-z. Epub 2009 Sep 21.

Results Reference

result

PubMed Identifier

31236956

Citation

Redifer Tremblay K, Lea WB, Neilson JC, King DM, Tutton SM. Percutaneous cryoablation for the treatment of extra-abdominal desmoid tumors. J Surg Oncol. 2019 Sep;120(3):366-375. doi: 10.1002/jso.25597. Epub 2019 Jun 24.

Results Reference

result

PubMed Identifier

27064168

Citation

Schmitz JJ, Schmit GD, Atwell TD, Callstrom MR, Kurup AN, Weisbrod AJ, Morris JM. Percutaneous Cryoablation of Extraabdominal Desmoid Tumors: A 10-Year Experience. AJR Am J Roentgenol. 2016 Jul;207(1):190-5. doi: 10.2214/AJR.15.14391. Epub 2016 Apr 11.

Results Reference

result

Learn more about this trial

Cryotherapy in the Treatment of Desmoid Tumors

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