PET Scans in Patients With Locally Advanced Breast Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: positron emission tomography (Procedure); fludeoxyglucose F 18 (Radiation); iodine I 124 iododeoxyuridine (Radiation)
Phase: N/A
Status: Recruiting
Sponsored by: Memorial Sloan-Kettering Cancer Center Official(s) and/or principal investigator(s):
Teresa Ann Gilewski, MD, Study Chair, Affiliation: Memorial Sloan-Kettering Cancer Center
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.
Clinical Details
Official title: Positron Emitter I-124-Iododeoxyuridine to Follow DNA Metabolism on Scans and in Tumor Samples in Advanced Breast Cancer: Comparison to 18-F-2-Fluoro-2-Deoxy-(D)-Glucose, as a Tracer for Glycolysis
Study design: Diagnostic
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS:
- Histologically confirmed locally advanced breast carcinoma
- Stage T3 T4, N2 or N3 disease
- Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Male or female
Menopausal status:
- Not specified
Performance status:
- Karnofsky 80-100%
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No history of psychiatric illness that would preclude giving informed consent
- Not pregnant
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Locations and Contacts
Memorial Sloan-Kettering Cancer Center, New York, New York 10021, United States; Recruiting
Teresa Ann Gilewski, MD, Phone: 646-888-4557
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: March 1997
Last updated: February 6, 2009
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