- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00019565
PET and/or MRI Scans in Assessing Tumor Response in Patients Receiving Antiangiogenesis Therapy
The Use of Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI) to Assess the Effects of Anti-neoplastic Therapy on Tumor Associated Vasculature
RATIONALE: Diagnostic procedures, such as PET and MRI scans, may help to measure a patient's response to treatment.
PURPOSE: This diagnostic trial is studying how well PET and/or MRI scans work in assessing changes in tumor blood supply in patients receiving antiangiogenesis therapy.
Study Overview
Status
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Evaluate the ability of positron emission tomography (PET) to assess the effect of therapy directed against tumor vasculatures on tumor blood flow and tumor blood volume in patients enrolled on a treatment protocol evaluating a therapeutic modality effecting the tumor associated vasculature.
- Evaluate the ability of PET to assess the effects of this type of therapy regimen on tumor uptake of fluorodeoxyglucose in these patients.
- Evaluate the ability of magnetic resonance imaging (MRI) to assess the effects of therapy directed against the tumor vasculature on tumor blood flow and tumor vascular density in these patients.
- Compare the findings on PET and/or MRI with those obtained from conventional CT in this patient population.
OUTLINE: This is a diagnostic study conducted concurrently with a therapeutic modality study.
Patients have magnetic resonance imaging and/or positron emission tomography (PET) scans performed prior to start of therapy, 6 weeks and 16 weeks following the initiation of therapy, and 6 weeks following the completion of therapy. Each scan requires about 1-3 hours. Patients receive up to 3 different PET scans including tumor blood flow scan with H2015, tumor blood volume scan with 11CO, and glucose uptake scan with fludeoxyglucose F 18.
PROJECTED ACCRUAL: A total of 145 patients will be accrued for this study within 2 years.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
- Eligible for a treatment protocol evaluating a therapeutic modality that may have an effect on tumor associated vasculature
- Measurable or evaluable disease by standard CT or MRI
- At least 1 lesion measuring greater than 2 cm in diameter
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Creatinine no greater than 2.0 mg/dL
Other:
- Not pregnant or nursing
- Negative pregnancy test
- No pacemakers, aneurysm clips, shrapnel injury, or implantable electronic devices
- Weight no greater than 136 kilograms
- No sensitivity to contrast agents that cannot be controlled with premedication
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Steven K. Libutti, MD, NCI - Surgery Branch
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 980163
- 98-C-0163
- CDR0000066720
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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