Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001148
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Detecting Malignant Brain Tumor Cells in the Bloodstream During Surgery to Remove the Tumor
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Detection of Glioblastoma or Anaplastic Astrocytoma Cells in the Circulation During Surgical Resection
Status:
COMPLETED
Status Verified Date:
2005-01
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:
Glioblastomas the most frequent malignant brain tumor in adults are widespread in the brain despite their discrete appearance on computed tomography CT or magnetic resonance imaging MRI While this tumor tends to spread widely in the brain unlike other tumors of the body it rarely metastasizes or spreads to other organs Approximately 10 percent of patients with glioblastoma develop metastatic disease after radiation or brain surgery In the absence of radiation or brain surgery few patients have developed disease spread outside the brain
During surgery to remove tumors of other organs of the body such as the lung prostate kidney or ovary cells from these tumors are routinely found in the bloodstream These cells are believed to be the reason for the spread of these tumors In the case of malignant brain tumors this process of glioma tumor cells shedding into circulation has not yet been investigated
This study will determine whether glioma cells can be detected in the bloodstream of patients undergoing surgery If glioma cells are absent it may mean they are unable to penetrate the blood-brain barrier If they are present they presumably can penetrate into blood vessels but they may be recognized and eliminated by the immune system or they may escape detection yet not be able to take hold in the new microenvironment The results of the study will add to the knowledge of the biology of these highly malignant tumors
Study participants will be admitted to the hospital for 8 to 10 days They will undergo a complete physical and neurological exam and blood and urine tests An electrocardiogram will be performed and x-rays may be taken On the morning of surgery the patient will receive sedation intravenously A tiny plastic tube called a catheter will be introduced into a vein in the groin through needles The catheter will be passed through to the jugular bulb right above the jugular vein on the same side as the tumor The patient will then be taken to the operating room for surgery During surgery not more than one quarter of a unit of blood will be removed through the catheter The catheter will be removed before the patient enters the intensive care unit Another MRI will be taken after surgery
The study will enroll participants for 2 years Patients will be followed at 3 months and 6 months after the surgery to make sure the postoperative period is uneventful
During surgery to remove tumors of other organs of the body such as the lung prostate kidney or ovary cells from these tumors are routinely found in the bloodstream These cells are believed to be the reason for the spread of these tumors In the case of malignant brain tumors this process of glioma tumor cells shedding into circulation has not yet been investigated
This study will determine whether glioma cells can be detected in the bloodstream of patients undergoing surgery If glioma cells are absent it may mean they are unable to penetrate the blood-brain barrier If they are present they presumably can penetrate into blood vessels but they may be recognized and eliminated by the immune system or they may escape detection yet not be able to take hold in the new microenvironment The results of the study will add to the knowledge of the biology of these highly malignant tumors
Study participants will be admitted to the hospital for 8 to 10 days They will undergo a complete physical and neurological exam and blood and urine tests An electrocardiogram will be performed and x-rays may be taken On the morning of surgery the patient will receive sedation intravenously A tiny plastic tube called a catheter will be introduced into a vein in the groin through needles The catheter will be passed through to the jugular bulb right above the jugular vein on the same side as the tumor The patient will then be taken to the operating room for surgery During surgery not more than one quarter of a unit of blood will be removed through the catheter The catheter will be removed before the patient enters the intensive care unit Another MRI will be taken after surgery
The study will enroll participants for 2 years Patients will be followed at 3 months and 6 months after the surgery to make sure the postoperative period is uneventful
Detailed Description:
Glioblastomas are the most frequent malignant brain tumor in adults and are widespread in the brain despite their discrete appearance on CT or MRI While locally aggressive metastasis of glioblastoma to extracranial organs is considered rare Approximately 10 of patients with glioblastoma develop metastatic disease after radiation or craniotomy Few patients have developed extracranial metastatic disease in the absence of surgical resection or radiation Unlike tumors of other organs such as lung colon and prostate the presence of glioma cells in the circulation of patients undergoing surgical resection has not been established If found absent glioma cells may be unable to intravasate through the blood brain barrier If present these tumor cells presumably can intravasate but may be recognized and eliminated by an immunological process or they may escape detection yet not be able to take hold in the new microenvironment The information provided will add to the knowledge of the biology of these highly malignant tumors
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 |
|---|---|---|---|
| 00-N-0009 | None | None | None |