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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05091255
Other study ID # CRYODESMO
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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