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ALA-induced PpIX Fluorescence During Brain Tumor Resection

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: NCT02191488
Recruitment Status : Active, not recruiting
First Posted : July 16, 2014
Last Update Posted : April 9, 2020
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
David W. Roberts, Dartmouth-Hitchcock Medical Center

Brief Summary:
Removing a tumor from a patients brain is hard to do because, very often, brain tumors do not have boundaries that are easy for the patients 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 the patient's tumor by looking at the MRI images that were taken of the patient's 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 the chances of survival.

Condition or disease Intervention/treatment Phase
Brain Tumors Drug: 5-aminolevulinic acid Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Quantification of ALA-induced PpIX Fluorescence During Brain Tumor Resection
Actual Study Start Date : July 2014
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

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




Primary Outcome Measures :
  1. Comparison of intraoperative measurements of PpIX concentration to coregistered histopathology [ Time Frame: Up to five years from the first surgery date ]
    To estimate the probability of tumor distribution for a given PpIX concentration by comparing intraoperative measurements with coregistered histopathology obtained from biopsy sampling during the procedure



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Preoperative diagnosis of either presumed first-time low or high grade glioma, or recurrent glioma, or metastasis, or meningioma
  • Tumor judged to be suitable for open cranial resection based on preoperative imaging studies.
  • Patient or LAR able to provide written informed consent.
  • No serious associated psychiatric illnesses.
  • 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.
  • Elevated liver function levels greater than 2.5 times the normal limit from laboratory tests conducted within 30 days prior to surgery.
  • Inability to comply with the photosensitivity precautions associated with the study.
  • Plasma creatinine in excess of 180umol/L within 30 days prior to surgery

Information from the National Library of Medicine

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): NCT02191488


Locations
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United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
David W. Roberts
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: David W. Roberts, MD Dartmouth-Hitchcock Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: David W. Roberts, Professor of Surgery (Neurosurgery), Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02191488    
Other Study ID Numbers: DMS 13066
R01NS052274-01A2 ( U.S. NIH Grant/Contract )
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: April 9, 2020
Last Verified: April 2020
Keywords provided by David W. Roberts, Dartmouth-Hitchcock Medical Center:
Fluorescence
Brain Tumors
Brain Metastases
Malignant Glioma
Brain Lesions
Additional relevant MeSH terms:
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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