Cryotherapy in the Treatment of Desmoid Tumors

Desmoid Clinical Trial

Official title:

Cryotherapy in the Treatment of Desmoid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05091255
• Other study ID #: CRYODESMO
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2021
• Est. completion date: January 1, 2027

Study information

• Verified date: May 2023
• Source: Istituto Ortopedico Rizzoli
• Contact: Costantino Errani, MD
• Phone: 051-6366
• Email: costantino.errani[@]ior.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Desmoid

Intervention

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.

Locations

Country	Name	City	State
Italy	IRCCS Itituto Ortopedico Rizzoli	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response to treatment	assessment of tumor response to treatment will be performed using the solid tumor response criteria	At baseline (time 0)