Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 94085 for:    5

The Use of 5-aminolevulinic Acid (ALA) as an Intraoperative Tumor Marker for Resection of Pediatric Central Nervous System (CNS) Tumors (5-ALA)

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: NCT02050243
Recruitment Status : Unknown
Verified January 2014 by michal roll, Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 30, 2014
Last Update Posted : January 30, 2014
Sponsor:
Information provided by (Responsible Party):
michal roll, Tel-Aviv Sourasky Medical Center

Brief Summary:

Surgery is the cornerstone treatment of most pediatric CNS tumors, including astrocytomas, ependymomas, medulloblastomas, and many other pathologies.

In most pediatric CNS tumors, the aim of surgery is maximal tumor resection, while preserving neurological function. Extent of tumor residual has been shown to be a major prognostic factor for progression free survival (PFS), and survival in several malignant and low-grade tumors such as medulloblastomas, ependymomas, and astrocytic tumors.

5-aminolevulinic acid (5-ALA) has been shown to be valuable in intraoperative marking of various cancers. Following oral admission, during surgery, the tumor tissue is illuminated by blue light. Tumor cells tend to metabolize 5-ALA to a porphyrin named protoporhyrin IX (PpIX). PpIX reacts with the blue light and emits a pinky color (- fluorescence). This enables the surgeon to better identify tumor cells and perform a more extensive resection.

Over recent years, many studies have proven the efficacy using 5-ALA for resecting various intracranial and spinal tumors, thus achieving a better tumor control.

In the suggested study, we propose using the same technique for various pediatric central nervous system tumors.

We will focus on the correlation between various pathologies and the fluorescence, trying to deduce the role of 5-ALA in resection of specific pathologies.

Also, we will study the safety of 5-ALA use in the pediatric population.


Condition or disease Intervention/treatment Phase
Central Nervous System Tumor, Pediatric Drug: 5ALA Phase 1 Phase 2

Detailed Description:

Following the above general description, eligible children will receive 5-aminolevulinic acid (5ALA) prior to surgery.

During surgery, careful attention will be payed to the fluorescence from the tumor, as well as the ability to differentiate between tumor and non tumorous tissue.

Comparisons between fluorescence and pathologies will be performed. Additionally, careful documentation of side effects will be done, to increase the safety of 5ALA use.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of 5-aminolevulinic Acid (ALA) as an Intraoperative Tumor Marker for Resection of Pediatric CNS Tumors
Study Start Date : February 2014
Estimated Primary Completion Date : February 2016
Estimated Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 5ALA
All included patients will receive 20mg/kg of 5ALA (oral suspension) about 3 hours prior to surgery
Drug: 5ALA
20mg/kg of oral suspension of 5ALA




Primary Outcome Measures :
  1. sensitivity of 5ALA fluorescence to intraoperatively detect pediatric CNS tumor tissue [ Time Frame: up to 2 weeks ]
    about 3hour following the 5ALA admission, the patient undergoes surgery. during surgery, global impression of tumor fluorescence will be appreciated (none, inhomogenous, intense homogenous) additionally, tumor samples will be taken from various regions, including various fluorescence regions, to try and correlate tumor regions (e.g. necrosis and viable tumor) with fluorescence (and measure the sensitivity of the 5ALA to the specific tumor)

  2. number of patients with 5ALA related side effects [ Time Frame: 2 weeks ]

    5ALA is known to cause skin hypersensitivity reaction following direct sun light exposure, during the first 48 hours after admission. also, transient elevation in liver enzymes have been documented.

    the investigators will supervise these reactions during the postoperative phase




Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 3 -18 years old
  • Any CNS related pathology (including intraaxial and extraaxial tumors, intracranial or spinal intradural) that is planned for either open (microscopic) resection (or biopsy), or lesions undergoing stereotactic biopsies.
  • Parental consent
  • No personal or familial (1st degree) history of porphyria
  • Liver function test within normal limits (alanine aminotransferase (ALT), aspartate aminotransferase (AST)<2 * upper normal limit)
  • Normal renal function (Cr <2)

Exclusion Criteria:

  • Surgery with no microscopic use (i.e. purely endoscopic surgeries)
  • History of hepatic disease within last 12 months
  • History of cutaneous photosensitivity, hypersensitivity to porphyrins, photodermatosis, exfoliative dermatitis, or porphyria
  • Inability to comply with photosensitivity precautions

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): NCT02050243


Contacts
Layout table for location contacts
Contact: Jonathan Roth, MD 972-524262095 jonaroth@gmail.com

Locations
Layout table for location information
Israel
Department of pediatric neurosurgery Not yet recruiting
Tel-Aviv, Israel, 64239
Contact: Jonathan Roth, MD    972-524262095    jonaroth@gmail.com   
Principal Investigator: Jonathan Roth, MD         
Sub-Investigator: Shlomi Constantini, MD, MSc         
Sub-Investigator: Liana Beni-Adani, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center

Layout table for additonal information
Responsible Party: michal roll, research and development director, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02050243     History of Changes
Other Study ID Numbers: TASMC-13-JR-528-CTIL
First Posted: January 30, 2014    Key Record Dates
Last Update Posted: January 30, 2014
Last Verified: January 2014
Keywords provided by michal roll, Tel-Aviv Sourasky Medical Center:
pediatrics
brain tumor
CNS
fluorescence
5ALA
Additional relevant MeSH terms:
Layout table for MeSH terms
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents