Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00071357
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2003-10-20
Brief Title:
Use of Dynamic Contrast-Enhanced Magnetic Resonance Imaging to Assess Tumor-Associated Vasculature in Patients With Metastatic Breast Cancer
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Use of Dynamic Contrast-Enhanced Magnetic Resonance Imaging to Assess Tumor-Associated Vasculature in Patients With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2004-10
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:
This study will examine a non-invasive method to assess vasculature that is the development of a blood supply necessary to the growth of tumors The hope is to identify the way that genes are expressed within the tumor itself from areas shown as low flow versus those shown as high flow on dynamic contrast-enhanced magnetic resonance imaging DCE-MRI
Most patients with solid epithelial cancers those that develop on free surfaces or linings inside the body die because of the distant spread of tumors-metastasis After that spread a cure is more difficult than if the tumors were detected early or locally Tumors develop a new supply of blood Traditional anticancer therapies have had the goal of causing a decline in the tumor Yet by focusing on the tumors blood supply microscopic differences between tumors and clonal differences within tumors may be avoided Doing so may overcome tumor resistance to treatment and may result in treatments that can be more universally applied across tumor types
Female patients 18 years of age enrolled in the protocol Analysis of Brain Metastasis in Patients with Breast Cancer with and without Over-Expression of HER-2 who will undergo an MRI scan immediately before surgery will be invited to participate in this study Patients seen in the oncology outpatient clinic of the NIH Clinical Center or by referral from outside physicians may be eligible for this study
Participants will undergo DCE-MRI immediately before the craniotomy-the surgery scheduled-in conjunction with other clinically indicated MRI The preoperative MRI will take about 30 minutes and the DCE-MRI will take no more than 15 minutes During the MRI patients will lie still on a table that can slide in and out of a metal cylinder surrounded by a strong magnetic field They may be asked to lie still for up to 5 minutes at a time As the scanner takes pictures there will be loud knocking noises and the patients will wear earplugs to muffle the sound Patients will be able to communicate with the MRI staff at all times during the scan and may ask to be moved out of the machine at any time During part of the MRI patients will receive a contrast agent one that is gadolinium-based into a vein This agent changes the relative brightness or contrast on the MRI image under some conditions Before that agent is used patients will be asked about any previous allergic reactions to gadolinium-based contrast agents
Most patients with solid epithelial cancers those that develop on free surfaces or linings inside the body die because of the distant spread of tumors-metastasis After that spread a cure is more difficult than if the tumors were detected early or locally Tumors develop a new supply of blood Traditional anticancer therapies have had the goal of causing a decline in the tumor Yet by focusing on the tumors blood supply microscopic differences between tumors and clonal differences within tumors may be avoided Doing so may overcome tumor resistance to treatment and may result in treatments that can be more universally applied across tumor types
Female patients 18 years of age enrolled in the protocol Analysis of Brain Metastasis in Patients with Breast Cancer with and without Over-Expression of HER-2 who will undergo an MRI scan immediately before surgery will be invited to participate in this study Patients seen in the oncology outpatient clinic of the NIH Clinical Center or by referral from outside physicians may be eligible for this study
Participants will undergo DCE-MRI immediately before the craniotomy-the surgery scheduled-in conjunction with other clinically indicated MRI The preoperative MRI will take about 30 minutes and the DCE-MRI will take no more than 15 minutes During the MRI patients will lie still on a table that can slide in and out of a metal cylinder surrounded by a strong magnetic field They may be asked to lie still for up to 5 minutes at a time As the scanner takes pictures there will be loud knocking noises and the patients will wear earplugs to muffle the sound Patients will be able to communicate with the MRI staff at all times during the scan and may ask to be moved out of the machine at any time During part of the MRI patients will receive a contrast agent one that is gadolinium-based into a vein This agent changes the relative brightness or contrast on the MRI image under some conditions Before that agent is used patients will be asked about any previous allergic reactions to gadolinium-based contrast agents
Detailed Description:
Introduction Metastasis of epithelial tumors such as breast cancer to the brain is a common problem with significant consequences with respect to neurological dysfunction and shortening of survival One necessary step for tumor growth anywhere is the development of a blood supply
Objectives We seek to compare a new non-invasive method of assessing neo-vascularization dynamic contrast-enhanced magnetic resonance imaging DCE-MRI with a gold-standard-microvessel counts-and to see if we can identify gene expression patterns within the tumor itself from areas shown as low flow versus those that are high-flow on DCE-MRI if there are features within the tumor itself that influence the degree of neovascularization This prospective study will only be utilized in conjunction the protocol entitled Analysis of Brain Metastasis in Patients with Breast Cancer with and without over-expression of HER-2 that is evaluating breast tumors metastatic to the brain
Study Population A series of women with breast cancer metastatic to the brain who do n39 or do not n39 over-express the growth factor receptor HER-2 entered into a prospective trial in which pre-operative MRI imaging is performed as a matter of standard medical practice At the time of this pre-operative MR we propose to add one additional 10-minute MR series a dynamic contrast-enhance image to assess the extent of blood flow through various aspects of the tumor
Anticipated Risks and Benefits There are no obvious risks or benefits to patients who participate in this protocol It is felt that this study involves no more than minimal risk
Estimation of OutcomePotential Meaning We believe that this protocol will help us identify tumors with higher or lower degrees of neovascularization as well as identify tumor-intrinsic factors via microarrays performed on microdissected tissues This is becoming an important issues as cytostatic treatments such as anti-angiogenic agents enter the clinical area and are used singly or in combination with cytotoxic therapies
Objectives We seek to compare a new non-invasive method of assessing neo-vascularization dynamic contrast-enhanced magnetic resonance imaging DCE-MRI with a gold-standard-microvessel counts-and to see if we can identify gene expression patterns within the tumor itself from areas shown as low flow versus those that are high-flow on DCE-MRI if there are features within the tumor itself that influence the degree of neovascularization This prospective study will only be utilized in conjunction the protocol entitled Analysis of Brain Metastasis in Patients with Breast Cancer with and without over-expression of HER-2 that is evaluating breast tumors metastatic to the brain
Study Population A series of women with breast cancer metastatic to the brain who do n39 or do not n39 over-express the growth factor receptor HER-2 entered into a prospective trial in which pre-operative MRI imaging is performed as a matter of standard medical practice At the time of this pre-operative MR we propose to add one additional 10-minute MR series a dynamic contrast-enhance image to assess the extent of blood flow through various aspects of the tumor
Anticipated Risks and Benefits There are no obvious risks or benefits to patients who participate in this protocol It is felt that this study involves no more than minimal risk
Estimation of OutcomePotential Meaning We believe that this protocol will help us identify tumors with higher or lower degrees of neovascularization as well as identify tumor-intrinsic factors via microarrays performed on microdissected tissues This is becoming an important issues as cytostatic treatments such as anti-angiogenic agents enter the clinical area and are used singly or in combination with cytotoxic therapies
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 |
|---|---|---|---|
| 04-N-0003 | None | None | None |