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Intralesional Cryosurgery for Basal Cell Carcinoma - a Feasibility Study

This study is not yet open for participant recruitment.
Verified July 2012 by Carmel Medical Center
Sponsor:
Information provided by (Responsible Party):
Yaron Har-Shai, Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT01633515
First received: June 9, 2012
Last updated: July 1, 2012
Last verified: July 2012
History of Changes
  Purpose

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


Condition Intervention
Basal Cell Carcinoma (BCC)
 Procedure: Intralesional cryotherapy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intralesional Cryosurgery for the Treatment of Basal Cell Carcinoma of the Lower Extremities in the Elderly - a Feasibility Study

Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:
  • Cure rate of intralesional cryotherapy for BCC in the lower extremity of elderly [ Time Frame: 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). ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 10
Study Start Date: July 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Intralesional cryotherapy
10 BCC (skin lesions) in the lower extremity of elderlies with risk factors for surgical complications.
 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).

Other Name: CryoShape; CryoShape™, FDA 510(k) Number K060928)

Detailed 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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01633515

Contacts
Contact: Yaron har-Shai, M.D 972057866206 yaron07@yahoo.com
Contact: Tamir Gil, M.D 972507308646 tamirgiloragil@walla.com

Sponsors and Collaborators
Carmel Medical Center
Investigators
Principal Investigator: Yaron Har-Shai, M.D Carmel Medical Center
  More Information

Publications:

Responsible Party: Yaron Har-Shai, Head of plastic department, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01633515     History of Changes
Other Study ID Numbers: CMC-12-0032-CTIL
Study First Received: June 9, 2012
Last Updated: July 1, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Carmel Medical Center:
Basal cell carcinoma (BCC)
Cryotherapy
Cryosurgery

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Basal Cell

ClinicalTrials.gov processed this record on May 19, 2013