PET Scans in Patients With Locally Advanced Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Imaging procedures such as PET scans may improve the ability to monitor the
      effectiveness of chemotherapy for locally advanced breast cancer.

      PURPOSE: This clinical trial is studying how well PET scans work in patients with locally
      advanced breast cancer who will undergo chemotherapy.
    

Detailed description: 
      OBJECTIVES:

        -  Determine whether the biologic activity of locally advanced breast cancer as measured by
           retention of iodine I 124 iododeoxyuridine (IUdR) on positron emission tomography (PET)
           scans pre- and postchemotherapy is different between patients whose tumor shrinks after
           treatment in comparison to patients whose tumor is stable or continues to grow.

        -  Demonstrate that incorporation of IUdR into tumor is in the tumor DNA at 24-36 hours
           post injection, as documented by tissue analysis and immunohistochemistry and that this
           correlates with the subsequent change in tumor dimension and proliferative activity of
           the tumor.

        -  Compare the pre and post treatment results of fludeoxyglucose (FDG) PET scanning and
           IUdR PET scanning in the same breast lesions as a basis for assessment of the relative
           metabolic change during chemotherapy.

        -  Further assess the biologic activity of metastatic tumor sites and their changes in size
           following chemotherapy to standard parameters that are used to evaluate change in tumor
           size, obtained under clinical standard of care for breast cancer, which will include CT
           scans as well as bone scans.

        -  Assess the accuracy of noninvasive measurement of PET measurement of the left
           ventricular cardiac chamber clearance of radioactivity as a substitute for arterial
           plasma sampling for determining metabolic rates of FDG and IUdR uptake into tumors.

        -  Evaluate metabolic changes in tumors as they are affected by specific chemotherapy in
           comparison to changes in tumor dimensions.

      OUTLINE: For this study, the chemotherapy administered for an individual patient is at the
      discretion of the patient's primary attending physician. After chemotherapy, the patient is
      evaluated for surgical resection of the tumor. If the tumor is unresectable, the patient may
      be offered radiation therapy.

      The first group of positron emission tomography (PET) scans is performed within 2 weeks
      before the first dose of chemotherapy. The second group of PET scans occur no more than 7
      weeks after chemotherapy and prior to local therapy, either surgery or radiation therapy.

      The PET scan before initiation of chemotherapy consists of 4 imaging sessions. There is one
      iodine I-124 iododeoxyuridine (IUdR) PET scan (3 imaging sessions) at 1, 4-8, and 24 hours
      after IUdR infusion, followed by one fludeoxyglucose (FDG) PET scan (1 imaging session) 45
      minutes after FDG infusion.

      PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study.
    

Intervention name(s): positron emission tomography; fludeoxyglucose F 18; iodine I 124 iododeoxyuridine
Intervention type(s): Procedure; Radiation; Radiation
Intervention MeSH terms: Idoxuridine; Fluorodeoxyglucose F18
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; male breast cancer