Fluorescence Guided Resection of Brain Tumors
| Status: | Completed |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/17/2018 |
| Start Date: | May 2007 |
| End Date: | July 2, 2013 |
Co-registered Fluorescence-Enhanced Resection of Brain Tumors Stage I: Correlation With MR and Biopsy
Removing a tumor from your brain is hard to do because, very often, brain tumors do not have
boundaries that are easy for your surgeon to find. In many cases, the surgeon can't tell
exactly where the tumor begins or ends. The surgeon usually can remove most of your tumor by
looking at the MRI images that were taken of your brain before surgery. However, the surgeon
does not have any good way to tell if the entire tumor has been removed or not. Removing the
entire tumor is very important because leaving tumor behind may allow it to grow back which
could decrease your chances of survival.
It is possible to detect tumor cells by making them glow with a specific color of light (a
process called fluorescence). This can be done by having you take the drug, ALA, before your
surgery. ALA is a molecule that already exists in the cells of your body. Once enough of it
is in your body, it gets converted into another molecule named PpIX. If blue light is shined
on a tumor that has enough PpIX, it will glow with red light (fluorescence) that can be
detected with a special camera. In this study, we want to determine how the fluorescence (red
light) is related to the tumor which appears in the images that are normally taken of your
brain (which the surgeon uses to guide the removal of your tumor) and the tumor tissue that
will be removed during your surgery. Removing the entire tumor is very important because
leaving tumor behind may allow it to grow back which could decrease your chances of survival.
boundaries that are easy for your surgeon to find. In many cases, the surgeon can't tell
exactly where the tumor begins or ends. The surgeon usually can remove most of your tumor by
looking at the MRI images that were taken of your brain before surgery. However, the surgeon
does not have any good way to tell if the entire tumor has been removed or not. Removing the
entire tumor is very important because leaving tumor behind may allow it to grow back which
could decrease your chances of survival.
It is possible to detect tumor cells by making them glow with a specific color of light (a
process called fluorescence). This can be done by having you take the drug, ALA, before your
surgery. ALA is a molecule that already exists in the cells of your body. Once enough of it
is in your body, it gets converted into another molecule named PpIX. If blue light is shined
on a tumor that has enough PpIX, it will glow with red light (fluorescence) that can be
detected with a special camera. In this study, we want to determine how the fluorescence (red
light) is related to the tumor which appears in the images that are normally taken of your
brain (which the surgeon uses to guide the removal of your tumor) and the tumor tissue that
will be removed during your surgery. Removing the entire tumor is very important because
leaving tumor behind may allow it to grow back which could decrease your chances of survival.
The first phase of study (Stage I) will use FI coregistered with pMR, iUS and iSV images to
test the overall hypothesis that there is a high degree of spatial correlation between local
tissue FI signal and coregistered conventional imaging and corresponding histopathology.
Additionally, coregistered probe measurements and biopsy specimens will be acquired
intraoperatively. Biopsy specimens will be processed post-operatively (via fluorescence
microscopy and chemical spectrofluorimetry) to assess PpIX concentration which will allow
direct comparisons of FI signal strength with PpIX production (based on both in vivo probe
data and ex vivo histological quantification) as a function of histological grade. The study
protocol is outlined below. Because of the overall interest and importance of relating this
data to the existing body of literature and the excellent safety record of oral
administration of ALA reported in these trials [1, 33-36], we will use the same dose/time
schedule described in [1, 33]. The operative procedures will follow existing practice at
Dartmouth for image-guided resection of meningiomas, pituitary adenomas and metastases with
additional acquisition of FI and biopsy data at predefined time points that are related to
the expected volume of tumor tissue. In this first phase of the study, resection decisions
will not be made based on FI data alone. Should residual fluorescence remain after the
intended resection volume has been removed further excisions will require biopsy confirmation
in the OR. It is anticipated that 234 patients will be enrolled in Stage I.
test the overall hypothesis that there is a high degree of spatial correlation between local
tissue FI signal and coregistered conventional imaging and corresponding histopathology.
Additionally, coregistered probe measurements and biopsy specimens will be acquired
intraoperatively. Biopsy specimens will be processed post-operatively (via fluorescence
microscopy and chemical spectrofluorimetry) to assess PpIX concentration which will allow
direct comparisons of FI signal strength with PpIX production (based on both in vivo probe
data and ex vivo histological quantification) as a function of histological grade. The study
protocol is outlined below. Because of the overall interest and importance of relating this
data to the existing body of literature and the excellent safety record of oral
administration of ALA reported in these trials [1, 33-36], we will use the same dose/time
schedule described in [1, 33]. The operative procedures will follow existing practice at
Dartmouth for image-guided resection of meningiomas, pituitary adenomas and metastases with
additional acquisition of FI and biopsy data at predefined time points that are related to
the expected volume of tumor tissue. In this first phase of the study, resection decisions
will not be made based on FI data alone. Should residual fluorescence remain after the
intended resection volume has been removed further excisions will require biopsy confirmation
in the OR. It is anticipated that 234 patients will be enrolled in Stage I.
Inclusion Criteria:
- Preoperative diagnosis of either presumed low or high grade glioma (astrocytoma,
oligodendroglioma, mixed oligo-astrocytoma, anaplastic astrocytoma, and glioblastoma
multiforme) or meningioma, pituitary adenoma or metastasis.
- Tumor judged to be suitable for open cranial resection based on preoperative imaging
studies.
- Patient able to provide written informed consent.
- Age ≥ 21 years old.
Exclusion Criteria:
- Pregnant women or women who are breast feeding
- History of cutaneous photosensitivity, porphyria, hypersensitivity to porphyrins,
photodermatosis, exfoliative dermatitis
- History of liver disease within the last 12 months,
- AST, ALT, ALP or bilirubin levels greater than 2.5 times the normal limit at any time
during the previous 2 months
- Plasma creatinine in excess of 180 mol/L.
- Inability to comply with the photosensitivity precautions associated with the study
- Patients with an existing DSM-IV Axis 1diagnosis
- Inability to give informed consent
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