Malignant TumorsNCT00165100
Dynamic Area Telethermometry (DAT) as an Imaging Modality in Patients With Cancer
A study testing Dynamic Area Telethermometry (DAT) in people with Malignant Tumors and Subcutaneous Tumors, run by Dana-Farber Cancer Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Malignant Tumors, Subcutaneous Tumors, Lymph Node Tumors
- What is being tested?
- Dynamic Area Telethermometry (DAT)
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2000to Oct 2002
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Uncontrolled motion
- Tumors not verified or measurable by standard imaging
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Dynamic Area Telethermometry (DAT) as an Auxiliary Imaging Modality in Assessment of Patients With Cancer
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.
Read the detailed 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.
- Conditions
- Malignant Tumors, Subcutaneous Tumors, Lymph Node Tumors
- Being tested
- Dynamic Area Telethermometry (DAT)
- Keywords
- DAT, imaging modality
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Area Telethermometry (DAT)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the feasibility of DAT in tumors detected by conventional imaging and evaluation of therapy induced changes in DAT imaging profile over time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startJan 2000
- Primary completionOct 2002
- Study completionOct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant TumorsStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Investigators
- Milos Janicek, MD, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00165100
- Sponsor's protocol ID
- 99-331
- Status last verified
- Dec 2007
- First submitted
- 9 Sep 2005
- Last updated
- 28 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Area Telethermometry (DAT) as an Auxiliary Imaging Modality in Assessment of Patients With Cancer
- ClinicalTrials.gov ID
- NCT00165100
- Acronym / sponsor ID
- 99-331
- Conditions
- Malignant Tumors, Subcutaneous Tumors, Lymph Node Tumors
- Keywords
- DAT, imaging modality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- Jan 2000
- Primary completion
- Oct 2002 (actual)
- Study completion
- Oct 2002 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Uncontrolled motion
- Tumors not verified or measurable by standard imaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic Area Telethermometry (DAT) | Procedure or surgery | – |
Primary outcome
To assess the feasibility of DAT in tumors detected by conventional imaging and evaluation of therapy induced changes in DAT imaging profile over time.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milos Janicek, MD, PhD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Area Telethermometry (DAT) in people with Malignant Tumors and Subcutaneous Tumors, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the feasibility of DAT in tumors detected by conventional imaging and evaluation of therapy induced changes in DAT imaging profile over time.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2007.