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5-Aminolevulinic Acid (5-ALA) to Enhance Visualization of Malignant Tumor

This study is currently recruiting participants.
Verified April 2017 by Constantinos Hadjipanayis, Icahn School of Medicine at Mount Sinai
Sponsor:
ClinicalTrials.gov Identifier:
NCT02632370
First Posted: December 16, 2015
Last Update Posted: August 8, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Constantinos Hadjipanayis, Icahn School of Medicine at Mount Sinai
  Purpose
In support of the US marketing application for 5-ALA, this single arm trial is being conducted to establish the efficacy and safety of Gliolan (5-ALA) in patients with newly diagnosed or recurrent malignant gliomas. The hypothesis of the study is Gliolan (5-ALA), as an adjunct to tumor resection, is safe and that real-time tissue fluorescence correlates with malignant histopathology. The primary objective in this single arm study is to define the positive predictive value (PPV) of Gliolan-induced PPIX fluorescence for malignant tumor at the time of initial resection and first use of FGS by taking a biopsy of tissue presenting with red fluorescence when observed during the course of resection of new or recurrent malignant gliomas. The functionality and performance reliability of the blue light excitation microscope platforms will be assessed.

Condition Intervention Phase
Malignant Gliomas Drug: Gliolan Procedure: Fluorescence-Guided Surgery Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Study of 5-Aminolevulinic Acid (5-ALA) to Enhance Visualization of Malignant Tumor in Patients With Newly Diagnosed or Recurrent Malignant Gliomas: A Safety, Histopathology, and Correlative Biomarker Study

Resource links provided by NLM:


Further study details as provided by Constantinos Hadjipanayis, Icahn School of Medicine at Mount Sinai:

Primary Outcome Measures:
  • Incidence of diagnostic tissue presence [ Time Frame: 6 weeks ]
    Pathologic confirmation of tumor type will be made by a pathologist who will not be informed of the fluorescence status of the tissue samples.


Secondary Outcome Measures:
  • Presence of malignant glioma tumor cells [ Time Frame: 6 weeks ]
    Pathologic confirmation of tumor type will be made by a pathologist who will not be informed of the fluorescence status of the tissue samples.

  • WHO tumor type with grading [ Time Frame: 6 weeks ]
    Pathologic confirmation of tumor type will be made by a pathologist who will not be informed of the fluorescence status of the tissue samples.

  • Ki-67 proliferation index [ Time Frame: 6 weeks ]
    Ki-67 is a prognostic marker for cancer

  • Karnofsky Performance Scale [ Time Frame: 6 weeks ]
    Scale from 0-100, function from low to high, with 100 being normal


Estimated Enrollment: 100
Study Start Date: May 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gliolan
Gliolan® is presented as a powder for oral solution in 60 ml colorless glass vials. The formulation contains 1.5 g 5-aminolevulinic acid hydrochloride corresponding to 1.17 g of 5-aminolevulinic acid. The oral solution is intended for single (partial) use.
Drug: Gliolan
single dose of oral 5-ALA (20mg/kg bodyweight) at 3 hours (range 2-5 hours) given preoperatively
Other Name: 5-ALA
Procedure: Fluorescence-Guided Surgery
performed utilizing blue light. At least 3-5 fluorescent tissue samples will be taken.
Other Name: FGS

Detailed Description:

Primary Objectives

  • To determine whether Gliolan® (5-ALA)-induced PPIX fluorescence correlates with malignant tumor histopathology (in a minimum of 3-5 serial biopsies taken from the red fluorescent region of tissue resection).
  • To determine the patient safety profile of both oral Gliolan® (5-ALA), as well as use of the fluorescence operative microscope. These will include use of commonly accepted toxicity measures as well as recording surgically-related neurological deficits within the six weeks after surgery.
  • To determine functionality and performance reliability of the blue light excitation microscope platforms (Zeiss Pentero, Leica OH4, Leica OH6 and others).

Secondary Objectives

  • To correlate PPIX-containing extracellular microvesicles recovered from blood (at multiple time points prior to and following tumor resection) with the pre-operative MRI tumor volume.
  • To characterize the presence and longitudinal changes in microvesicle biomarkers recovered from blood evaluating EGFRvIII, IDH1/2 wt and mutations and others. These microvesicular blood genes will be identified and correlated with the same microvesicular genes identified in tissue at the time of surgery.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects included must have an MRI documenting a primary brain tumor for which resection is indicated and has been planned. These patients will include those with newly diagnosed or recurrent malignant gliomas. Standard criteria for diagnosis will include a distinct ring-like pattern of contrast enhancement with thick irregular walls on MRI for patients with a presumed newly diagnosed malignant glioma.
  • Age 18-80.
  • Karnofsky>60%.
  • Subjects must have normal organ and marrow function as defined below:

Leukocytes >3,000/mL Platelets >100,000/mL Total bilirubin below upper limit of normal AST (SGOT)/ALT (SGPT) <2.5 X institutional upper limit of normal Creatinine below upper limit of normal OR Creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.

  • The effects of 5-aminolevulinic Acid (5-ALA) on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. A pregnancy test will be performed for all women of childbearing ability prior to surgery (see Exclusion Criteria below). Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Ability to understand and the willingness to sign a written informed consent document. Translation will be provided as appropriate by institution.
  • Inclusion of Women and Minorities: Both men and women and members of all ethnic groups are eligible for this trial.

Exclusion Criteria:

  • Patients with radiographic tumors of, or involving, nonresectable midline, the basal ganglia, or brain stem as assessed by MRI.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to aminolevulinic acid (ALA). Patients should refrain from use of other potential phototoxic substances (e.g. tetracyclines, sulfonamides, fluoroquinolones, hypericin extracts) for 72 h.
  • Personal or family history of porphyria.
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. . Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 5-aminolevulinic acid (5-ALA), breastfeeding should be discontinued if the mother is treated with 5-aminolevulinic acid (5-ALA).
  • Women who are pregnant will be excluded from the trial as aminolevulinic acid (ALA) is unknown to be teratogenic or have abortifacient effects Prior history of GI perforation, diverticulitis, and/or peptic ulcer disease.
  Contacts and Locations
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): NCT02632370


Contacts
Contact: Constantinos G Hadjipanayis, MD, PhD 212-844-6922 constantinos.hadjipanayis@mountsinai.org

Locations
United States, California
University of California San Diego Not yet recruiting
La Jolla, California, United States, 92093
Principal Investigator: Bob Carter, MD, PhD         
United States, Florida
Delray Medical Center Recruiting
Delray Beach, Florida, United States, 33484
Principal Investigator: Lloyd Zucker, MD         
United States, Idaho
Saint Alphonsus Regional Medical Center Recruiting
Boise, Idaho, United States, 83706
Contact: Terra Inman, BS, CCRC    208-367-7397    terra.inman@saintalphonsus.org   
Principal Investigator: Bruce Andersen, MD,PHD, FACS         
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Principal Investigator: Roukoz B Chamoun, MD         
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Principal Investigator: Steve Kalkanis, MD         
United States, Minnesota
CentraCare St. Cloud Hospital Recruiting
Saint Cloud, Minnesota, United States, 56303
Principal Investigator: Jerone Kennedy, MD         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Principal Investigator: Michael R Chicoine, MD         
United States, New Mexico
University of New Mexico School of Medicine, Department of Neurosurgery Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Ronald Mimis, CRC    505-272-3417      
Principal Investigator: Muhammad Omar Chohan, MD         
United States, New York
Mount Sinai Beth Israel Recruiting
New York, New York, United States, 10003
Principal Investigator: Constantinos G Hadjipanayis, MD, PhD         
Principal Investigator: Germano Isabelle, MD, PhD         
Mount Sinai St Luke's Withdrawn
New York, New York, United States, 10025
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Principal Investigator: Isabelle Germano, MD, PhD         
Sponsors and Collaborators
Constantinos Hadjipanayis
University of California, San Diego
Investigators
Principal Investigator: Isabelle Germano, MD, PhD Icahn School of Medicine at Mount Sinai
  More Information

Responsible Party: Constantinos Hadjipanayis, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02632370     History of Changes
Other Study ID Numbers: GCO 15-2034-0001
CGH932015 ( Other Identifier: Clinical Trials Regulatory Compliance Specialists )
PRMC 15-085 ( Other Identifier: Mount Sinai Hospital )
First Submitted: December 9, 2015
First Posted: December 16, 2015
Last Update Posted: August 8, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Constantinos Hadjipanayis, Icahn School of Medicine at Mount Sinai:
Malignant Gliomas
5-ALA
tumor resection
malignant tumor

Additional relevant MeSH terms:
Glioma
Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents