Fluorescence Guided Resection of Brain Tumors (FGR)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2014 by Dartmouth-Hitchcock Medical Center.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by (Responsible Party):

Dartmouth-Hitchcock Medical Center

ClinicalTrials.gov Identifier:

NCT00870779

First received: March 25, 2009

Last updated: August 28, 2014

Last verified: August 2014

History of Changes

Purpose

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.

Condition	Intervention	Phase
Brain Tumors	Drug: 5-aminolevulinic acid	Phase 1


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Co-registered Fluorescence-Enhanced Resection of Brain Tumors Stage I: Correlation With MR and Biopsy

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Aminolevulinic acid Aminolevulinic acid hydrochloride

Genetic and Rare Diseases Information Center resources: Glioma Meningioma

U.S. FDA Resources

Further study details as provided by Dartmouth-Hitchcock Medical Center:

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. [ Time Frame: From date of first surgery through 6/1/2013 ] [ Designated as safety issue: No ]

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. [ Time Frame: From date of first surgery through 6/1/2013 ] [ Designated as safety issue: No ]


Estimated Enrollment:	234
Study Start Date:	May 2007
Estimated Study Completion Date:	August 2015
Estimated Primary Completion Date:	August 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 5-aminolevulinic acid	Drug: 5-aminolevulinic acid 20mg/kg 3 hours prior to surgery Other Name: 5-ALA

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.

Eligibility


Ages Eligible for Study:	21 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00870779

Locations


United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center

Investigators


Principal Investigator:	David W Roberts, MD	Dartmouth-Hitchcock Medical Center
Principal Investigator:	Keith Paulsen, PhD	Dartmouth-Hitchcock Medical Center

More Information


Responsible Party:	Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:	NCT00870779 History of Changes
Other Study ID Numbers:	DMS 0711 R01NS052274-01A2
Study First Received:	March 25, 2009
Last Updated:	August 28, 2014
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dartmouth-Hitchcock Medical Center:


Fluorescence Brain Tumor Malignant Glioma Pituitary Tumor	Skull Base Tumor Brain Lesions Brain Metastases Meningioma

Additional relevant MeSH terms:


Brain Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases	Central Nervous System Diseases Nervous System Diseases Aminolevulinic Acid Photosensitizing Agents Dermatologic Agents

ClinicalTrials.gov processed this record on September 23, 2016

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