Dynamic Area Telethermometry (DAT) as an Imaging Modality in Patients With Cancer

Malignant Tumors Clinical Trial

Official title:

Dynamic Area Telethermometry (DAT) as an Auxiliary Imaging Modality in Assessment of Patients With Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00165100
• Other study ID #: 99-331
• Status: Completed
• Phase: N/A
• First received: September 9, 2005
• Last updated: December 20, 2007
• Start date: January 2000
• Est. completion date: October 2002

Study information

• Verified date: December 2007
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether this new method of taking pictures called Dynamic Area Telethermometry (DAT) might be a good way of looking at patients with cancer that is relatively close to the surface of the body.

Description:

• The DAT system resembles a video camera which picks up changes in body temperature which may reflect disease-related changes in blood flow to some areas, particularly those involved with tumors.

• Patients with known tumor sites amendable to DAT evaluation will be imaged at the time of staging and at later time points. Thermal profiles will be compared to those of normal adjacent tissues and correlated with the images of the tumors on conventional images.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2002
• Est. primary completion date: October 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed malignancy

• Primary or secondary tumor location amendable to DAT scanning: subcutaneous tissues

• Older than 15 years of age

• Able to withhold movement for 20 seconds, hold breath for 20 seconds for chest wall lesions and clinically stable acutely

Exclusion Criteria:

• Uncontrolled motion

• Tumors not verified or measurable by standard imaging

Study Design

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

Related Conditions & MeSH terms

• Lymph Node Tumors
• Malignant Tumors
• Neoplasms
• Subcutaneous Tumors

Intervention

Procedure:
• Dynamic Area Telethermometry (DAT)

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the feasibility of DAT in tumors detected by conventional imaging and evaluation of therapy induced changes in DAT imaging profile over time.