Intralesional Cryosurgery for Basal Cell Carcinoma - a Feasibility Study

Basal Cell Carcinoma (BCC) Clinical Trial

Official title:

Intralesional Cryosurgery for the Treatment of Basal Cell Carcinoma of the Lower Extremities in the Elderly - a Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01633515
• Other study ID #: EMC-12-0032-CTIL
• Status: Recruiting
• Phase: N/A
• First received: June 9, 2012
• Last updated: December 2, 2013
• Start date: July 2012
• Est. completion date: July 2014

Study information

• Verified date: December 2013
• Source: Carmel Medical Center
• Contact: Yaron har-Shai, M.D
• Phone: 972057866206
• Email: yaron07[@]yahoo.com
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

A feasibility study for the treatment of Basal Cell Carcinoma of the lower extremities in the elderly utilizing intralesional cryosurgery.

10 cases of BCC (confirmed by biopsy) in the lower extremity of elderly will undergo intralesional cryotherapy. A Cryoneedle is introduced through the skin lesion (BCC) and thus the BCC is frozen. Treatment success will be determined according to biopsy results 3 months after treatment

Description:

BCC is the most common skin cancer. Many treatment modalities are acceptable including cryotherapy - freezing of the skin lesion with liquid nitrogen. This method is highly effective for the treatment of BCC. The purpose of this study is to determine the cure rates of BCC utilizing intralesional cryotherapy.

surgery in the gold standard for the treatment of BCC, however in the case of skin malignancy in the elderly and in the lower extremity, surgical complication (including skin grafting) are high. Therefore cryotherapy which is a non surgical treatment method provides an optimal therapeutic choice.

10 cases of BCC (confirmed by biopsy) in the lower extremity of elderly will undergo intralesional cryotherapy. A Cryoneedle is introduced through the skin lesion and the BCC is frozen. Treatment success will be determined according to biopsy results 3 months after treatment. Participants will be followed at the out patient clinic for the duration of wound healing, an expected average duration of 3 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: July 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Patients over 60 years old

• BCC was determined with tissue diagnosis in the lower extremity

• One or more risk factor for surgical complication including: diabetes, venous insufficiency, obesity, peripheral vascular disease, lymphedema and long term steroids use.

Exclusion Criteria:

• Patient unable to read, understand and sign the consent form

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Basal Cell Carcinoma (BCC)
• Carcinoma
• Carcinoma, Basal Cell

Intervention

Procedure:
• Intralesional cryotherapy
The Intralesional cryotherapy technology (CryoShape; CryoShape™, U.S Patent Number 6,503,246; European Patent Number 1299043, FDA 510(k) Number K060928) had been developed for the treatment of hypertrophic scars and keloids. The cryoneedle is connected by an adaptor to a cryogun filled with liquid nitrogen, and is introduced into the BCC. After the BCC is completely frozen, the cryoprobe defrosts and is withdrawn. Other relevant intervention: The cryotherapy will be performed under local anesthesia (bupivacaine). After the procedure topical antibiotic cream will be applied. Participants will be followed at the out patient clinic for an average duration of 5 month after cryotherapy (3 month post cyotherapy until the biopsy and then 1-2 month more until biopsy results are received).

Locations

Country	Name	City	State
Israel	Lin Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Carmel Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (3)

Giuffrida TJ, Jimenez G, Nouri K. Histologic cure of basal cell carcinoma treated with cryosurgery. J Am Acad Dermatol. 2003 Sep;49(3):483-6. — View Citation

Har-Shai Y, Brown W, Labbé D, Dompmartin A, Goldine I, Gil T, Mettanes I, Pallua N. Intralesional cryosurgery for the treatment of hypertrophic scars and keloids following aesthetic surgery: the results of a prospective observational study. Int J Low Extrem Wounds. 2008 Sep;7(3):169-75. doi: 10.1177/1534734608322813. — View Citation

Har-Shai Y, Brown W, Pallua N, Zouboulis CC. Intralesional cryosurgery for the treatment of hypertrophic scars and keloids. Plast Reconstr Surg. 2010 Nov;126(5):1798-800; author reply 1800. doi: 10.1097/PRS.0b013e3181ef823d. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cure rate of intralesional cryotherapy for BCC in the lower extremity of elderly	Cure rates of BCC in the lower extremity of elderly treated with intralesional cryotherapy. A biopsy will be performed 3 month post cryotherapy, the rate of biopsies which determine that no residual tumor is left will be defined as cure rate	Participants will be followed at the out patient clinic for an average duration of 5 month after cryotherapy (3 month post cyotherapy until the biopsy and then 1-2 month more until biopsy results are received).	No