Ultrasound Biomicroscopy - Apoptosis
Primary Purpose
Lymphoma, Lymphoma, Non-Hodgkin, Melanoma
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
high frequency ultrasound imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Lymphoma
Eligibility Criteria
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: -
Sites / Locations
- Princess Margaret Hospital
Outcomes
Primary Outcome Measures
Feasibility study of the use of Ultrasound Biomicroscopy for monitoring tumour response of lymphoma and melanoma patients to chemotheapy or radiation therapy.
Secondary Outcome Measures
Full Information
NCT ID
NCT00188370
First Posted
September 9, 2005
Last Updated
September 9, 2005
Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
1. Study Identification
Unique Protocol Identification Number
NCT00188370
Brief Title
Ultrasound Biomicroscopy - Apoptosis
Official Title
Ultrasound Biomicroscopy for Monitoring Apoptosis in Lymphoma, Melanoma and Basal Cell Carcinoma Patients During Chemotherapy or Radiation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
April 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Lymphoma, Non-Hodgkin, Melanoma, Carcinoma, Basal Cell
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
high frequency ultrasound imaging
Primary Outcome Measure Information:
Title
Feasibility study of the use of Ultrasound Biomicroscopy for monitoring tumour response of lymphoma and melanoma patients to chemotheapy or radiation therapy.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Tsang, MD
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Ultrasound Biomicroscopy - Apoptosis
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