Fluorescence Guided Resection of Brain Tumors (FGR)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00870779 |
Recruitment Status :
Completed
First Posted : March 27, 2009
Last Update Posted : June 14, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment | Phase |
---|---|---|
Brain Tumors | Drug: 5-aminolevulinic acid | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 105 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Co-registered Fluorescence-Enhanced Resection of Brain Tumors Stage I: Correlation With MR and Biopsy |
Study Start Date : | May 2007 |
Actual Primary Completion Date : | July 2, 2012 |
Actual Study Completion Date : | July 2, 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: 5-aminolevulinic acid |
Drug: 5-aminolevulinic acid
20mg/kg 3 hours prior to surgery
Other Name: 5-ALA |
- 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 ]
- 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 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00870779
United States, New Hampshire | |
Dartmouth-Hitchcock Medical Center | |
Lebanon, New Hampshire, United States, 03756 |
Principal Investigator: | David W Roberts, MD | Dartmouth-Hitchcock Medical Center | |
Principal Investigator: | Keith Paulsen, PhD | Dartmouth-Hitchcock Medical Center |
Responsible Party: | David W. Roberts, Professor of Surgery (Neurosurgery), Dartmouth-Hitchcock Medical Center |
ClinicalTrials.gov Identifier: | NCT00870779 |
Other Study ID Numbers: |
DMS 0711 R01NS052274-01A2 ( U.S. NIH Grant/Contract ) |
First Posted: | March 27, 2009 Key Record Dates |
Last Update Posted: | June 14, 2019 |
Last Verified: | June 2019 |
Fluorescence Brain Tumor Malignant Glioma Pituitary Tumor |
Skull Base Tumor Brain Lesions Brain Metastases Meningioma |
Brain Neoplasms Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Aminolevulinic Acid Photosensitizing Agents Dermatologic Agents |