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PET and/or MRI Scans in Assessing Tumor Response in Patients Receiving Antiangiogenesis Therapy

Sponsor
National Institutes of Health Clinical Center (CC) (NIH)
Overall Status
Completed
CT.gov ID
NCT00019565
Collaborator
National Cancer Institute (NCI) (NIH)
53
Enrollment
1
Location

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: magnetic resonance imaging
  • Procedure: positron emission tomography
  • Radiation: fludeoxyglucose F 18
 Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
53 participants
Primary Purpose:
Diagnostic
Official Title:
The Use of Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI) to Assess the Effects of Anti-neoplastic Therapy on Tumor Associated Vasculature
Study Start Date :
Oct 1, 1998
Actual Primary Completion Date :
Aug 1, 2008

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office Bethesda Maryland United States 20892-1182

    Sponsors and Collaborators

    • National Institutes of Health Clinical Center (CC)
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Steven K. Libutti, MD, NCI - Surgery Branch

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Institutes of Health Clinical Center (CC)
    ClinicalTrials.gov Identifier:
    NCT00019565
    Other Study ID Numbers:
    • 980163
    • 98-C-0163
    • CDR0000066720
    • NCT00001709
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Sep 26, 2016
    Last Verified:
    Sep 1, 2016
    Keywords provided by National Institutes of Health Clinical Center (CC)
    unspecified adult solid tumor, protocol specific
    Additional relevant MeSH terms:
    Neoplasms
    Fluorodeoxyglucose F18

    Study Results

    No Results Posted as of Sep 26, 2016