Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109785
Status:
COMPLETED
Last Update Posted:
2015-12-24
First Post:
2005-05-03
Brief Title:
PET Scans in Patients With Locally Advanced Breast Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 patients 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
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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G97-1308 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000065706 | REGISTRY | None | None |