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Fluorescence Guided Resection of Brain Tumors (FGR)

Primary Purpose

Brain Tumors

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
5-aminolevulinic acid
Sponsored by
David W. Roberts
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Tumors focused on measuring Fluorescence, Brain Tumor, Malignant Glioma, Pituitary Tumor, Skull Base Tumor, Brain Lesions, Brain Metastases, Meningioma

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dartmouth-Hitchcock Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

5-aminolevulinic acid

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Establish the clinical feasibility of integrating FI with conventional image guidance (pMR, iUS and iSV data). Determine the relationships between FI signals, PpIX concentration, histological grade and image features evident for surgical guidance.

Full Information

First Posted
March 25, 2009
Last Updated
June 12, 2019
Sponsor
David W. Roberts
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT00870779
Brief Title
Fluorescence Guided Resection of Brain Tumors
Acronym
FGR
Official Title
Co-registered Fluorescence-Enhanced Resection of Brain Tumors Stage I: Correlation With MR and Biopsy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
July 2, 2012 (Actual)
Study Completion Date
July 2, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David W. Roberts
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumors
Keywords
Fluorescence, Brain Tumor, Malignant Glioma, Pituitary Tumor, Skull Base Tumor, Brain Lesions, Brain Metastases, Meningioma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5-aminolevulinic acid
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
5-aminolevulinic acid
Other Intervention Name(s)
5-ALA
Intervention Description
20mg/kg 3 hours prior to surgery
Primary Outcome Measure Information:
Title
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.
Time Frame
From date of first surgery through 6/1/2013
Secondary Outcome Measure Information:
Title
Establish the clinical feasibility of integrating FI with conventional image guidance (pMR, iUS and iSV data). Determine the relationships between FI signals, PpIX concentration, histological grade and image features evident for surgical guidance.
Time Frame
From date of first surgery through 6/1/2013

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David W Roberts, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Keith Paulsen, PhD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Fluorescence Guided Resection of Brain Tumors

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