The Use of 5-aminolevulinic Acid (ALA) as an Intraoperative Tumor Marker for Resection of Pediatric Central Nervous System (CNS) Tumors (5-ALA)
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|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
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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
All included patients will receive 20mg/kg of 5ALA (oral suspension) about 3 hours prior to surgery
20mg/kg of oral suspension of 5ALA
- 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)
- 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
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
|Contact: Jonathan Roth, MDfirstname.lastname@example.org|
|Department of pediatric neurosurgery|
|Tel-Aviv, Israel, 64239|
|Contact: Jonathan Roth, MD 972-524262095 email@example.com|
|Principal Investigator: Jonathan Roth, MD|
|Sub-Investigator: Shlomi Constantini, MD, MSc|
|Sub-Investigator: Liana Beni-Adani, MD|