Ultrasound Biomicroscopy - Apoptosis

Lymphoma Clinical Trial

Official title:

Ultrasound Biomicroscopy for Monitoring Apoptosis in Lymphoma, Melanoma and Basal Cell Carcinoma Patients During Chemotherapy or Radiation Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00188370
• Other study ID #: UHN REB 01-0508-C
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: September 9, 2005
• Start date: April 1999
• Est. completion date: December 2004

Study information

• Verified date: September 2005
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

A group of researchers at the Ontario Cancer Institute/Princess Margaret Hospital have discovered that a very specific form of cell death 'apoptosis' can be detected using high-frequency ultrasound imaging. This type of cell death is recognized to occur in tumours in response to various different chemotherapeutic drugs and in response to radiation therapy. This group of researchers has confirmed that high-frequency ultrasound can detect apoptosis in response to tumour treatments experimentally using cell culture and experimental animal systems. The ultrasound approach is now being evaluated clinically in a 3-year clinical trial enrolling a target of 200 patients including Hodgkin's disease and non-Hodgkin's disease lymphoma patients, melanoma patients and patients with basal cell carcinoma. Our hope is to be able to use this type of imaging system in the future to clinically monitor the effects of therapy on tumours and rapidly detect tumours which are not responding so that changes in therapy can be made much quicker than presently possible.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• lymphoma patients with superficial lesions prior to starting chemotherapy or after relapse of disease

• patients with superficial melanoma lesions

• patients with superficial basal cell carcinoma lesions

• Informed consent

Exclusion Criteria:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma, Basal Cell
• Lymphoma
• Lymphoma, Non-Hodgkin
• Melanoma

Intervention

Procedure:
• high frequency ultrasound imaging

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility study of the use of Ultrasound Biomicroscopy for monitoring tumour response of lymphoma and melanoma patients to chemotheapy or radiation therapy.