Breast NeoplasmsNCT00071357
Use of Dynamic Contrast-Enhanced Magnetic Resonance Imaging to Assess Tumor-Associated Vasculature in Patients With Metastatic Breast Cancer
An observational study of Breast Neoplasms, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Neoplasms
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Oct 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A woman with a known or with radiographic evidence of a breast neoplasm metastatic to the brain, who has agreed to participate in the protocol "Analysis of Brain Metastasis in Patients with Breast Cancer, with and without over-expression of HER-2," and who will undergo a pre-operative MR scan immediately before surgery.
- Medically-indicated (diagnostic and/or therapeutic) brain tumor resection.
- Informed consent from female patient, age 18 or older. In general, patients less than 18 years of age rarely have breast cancer metastatic to the brain.
Who cannot join
- Inability to provide informed consent prior to surgery.
- Medical conditions that cannot be corrected prior to surgery that would be standard contraindications for craniotomy (brain tumor patients).
- Conditions that preclude MR imaging of the brain (Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices) or known allergy to gadolinium.
- Men
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
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 tumor's 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.
Read more
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.
Read the 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 (n=39) or do not (n=39) 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 Outcome/Potential 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.
- Conditions
- Breast Neoplasms
- Keywords
- Microarray, Herceptin, Trastuzumab, Carcinoma, Proteomics, Breast Cancer, Metastatic Breast Cancer, Metastatic Breast Tumor
- Medical subject headings
- Breast Neoplasms, Carcinoma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2003 (estimated)
- Study startOct 2003
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 78 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00071357
- Sponsor's protocol ID
- 040003
- Other IDs
- 04-N-0003
- Status last verified
- Oct 2004
- First submitted
- 20 Oct 2003
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Steeg PS. Metastasis suppressors alter the signal transduction of cancer cells. Nat Rev Cancer. 2003 Jan;3(1):55-63. doi: 10.1038/nrc967.
PubMed 12509767Chambers AF, Groom AC, MacDonald IC. Dissemination and growth of cancer cells in metastatic sites. Nat Rev Cancer. 2002 Aug;2(8):563-72. doi: 10.1038/nrc865.
PubMed 12154349Patchell RA, Tibbs PA, Walsh JW, Dempsey RJ, Maruyama Y, Kryscio RJ, Markesbery WR, Macdonald JS, Young B. A randomized trial of surgery in the treatment of single metastases to the brain. N Engl J Med. 1990 Feb 22;322(8):494-500. doi: 10.1056/NEJM199002223220802.
PubMed 2405271
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Dynamic Contrast-Enhanced Magnetic Resonance Imaging to Assess Tumor-Associated Vasculature in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00071357
- Acronym / sponsor ID
- 040003
- Conditions
- Breast Neoplasms
- Keywords
- Microarray, Herceptin, Trastuzumab, Carcinoma, Proteomics, Breast Cancer, Metastatic Breast Cancer, Metastatic Breast Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Oct 2003
- Study completion
- Oct 2004
- First posted
- 13 Oct 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 tumor's 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 (n=39) or do not (n=39) 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 Outcome/Potential 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 design
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- A woman with a known or with radiographic evidence of a breast neoplasm metastatic to the brain, who has agreed to participate in the protocol "Analysis of Brain Metastasis in Patients with Breast Cancer, with and without over-expression of HER-2," and who will undergo a pre-operative MR scan immediately before surgery.
- Medically-indicated (diagnostic and/or therapeutic) brain tumor resection.
- Informed consent from female patient, age 18 or older. In general, patients less than 18 years of age rarely have breast cancer metastatic to the brain.
Key exclusion criteria (4 listed)
- Inability to provide informed consent prior to surgery.
- Medical conditions that cannot be corrected prior to surgery that would be standard contraindications for craniotomy (brain tumor patients).
- Conditions that preclude MR imaging of the brain (Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices) or known allergy to gadolinium.
- Men
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 12509767Steeg PS. Metastasis suppressors alter the signal transduction of cancer cells. Nat Rev Cancer. 2003 Jan;3(1):55-63. doi: 10.1038/nrc967.
- Background: PubMed 12154349Chambers AF, Groom AC, MacDonald IC. Dissemination and growth of cancer cells in metastatic sites. Nat Rev Cancer. 2002 Aug;2(8):563-72. doi: 10.1038/nrc865.
- Background: PubMed 2405271Patchell RA, Tibbs PA, Walsh JW, Dempsey RJ, Maruyama Y, Kryscio RJ, Markesbery WR, Macdonald JS, Young B. A randomized trial of surgery in the treatment of single metastases to the brain. N Engl J Med. 1990 Feb 22;322(8):494-500. doi: 10.1056/NEJM199002223220802.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00071357, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.