Status:
COMPLETED
MRI Sarcoma Non Invasive Thermometry
Lead Sponsor:
Mark Dewhirst
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature. Using MRI to measure heat may help to determine the effectiveness of hyperthermia therapy. ...
Detailed Description
OBJECTIVES: Primary * Determine the feasibility and accuracy of real time magnetic resonance-based non-invasive thermometry in patients with grade 2 or 3 soft tissue sarcoma of the extremity receivi...
Eligibility Criteria
Inclusion
- Patients will have histologically proven grade 2 or grade 3 soft tissue sarcoma.
- Karnofsky performance status ≥ 70.
- Life expectancy ≥ 6 months.
- There is no specific tumor size limitation, but the involved extremity must fit within the hyperthermia applicator.
- Patients must be ≥ 18 years of age.
- Patients who are to receive chemotherapy must have a left ventricular ejection fraction on resting MUGA scan of at least 45% to confirm adequate cardiac function
- Patients must competent to consent to be in the study and sign an approved informed consent.
Exclusion
- Pregnant patients
- Patients with cardiac pacemakers and implanted defibrillators or other devices not compatible with ultrasound or microwave technology
- Patients who have any metal in their bodies including orthopedic rods, surgical clips, bullets, or shrapnel, etc. unless cleared by MRI staff and Hyperthermia physicians
Key Trial Info
Start Date :
November 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00093509
Start Date
November 1 1999
End Date
October 1 2009
Last Update
September 1 2014
Active Locations (1)
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1
Duke Cancer Institute
Durham, North Carolina, United States, 27710