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Co-registered Fluorescence-Enhanced Resection of Brain Tumors Stage I: Correlation With MR and Biopsy


Phase 1
21 Years
N/A
Open (Enrolling)
Both
Brain Tumors

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Trial Information

Co-registered Fluorescence-Enhanced Resection of Brain Tumors Stage I: Correlation With MR and Biopsy


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Determine the degree of spatial correlation between local fluorescence recorded intraop and coregistered conventional imaging obtained preop with MR and intraop with ultrasound and operating microscope stereovision.

Outcome Time Frame:

From date of first surgery through 6/1/2013

Safety Issue:

No

Principal Investigator

David W Roberts, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dartmouth-Hitchcock Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

DMS 0711

NCT ID:

NCT00870779

Start Date:

May 2007

Completion Date:

June 2013

Related Keywords:

  • Brain Tumors
  • Fluorescence
  • Brain Tumor
  • Malignant Glioma
  • Pituitary Tumor
  • Skull Base Tumor
  • Brain Lesions
  • Brain Metastases
  • Meningioma
  • Brain Neoplasms

Name

Location
Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756