Clinical Trial Finder

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

Study 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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Observational
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT02632370

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Constantinos Hadjipanayis

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Bob Carter, MD, PhD
Principal Investigator Affiliation Massachusetts General Hospital

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
OtherOther
Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Malignant Gliomas
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California San Diego, La Jolla, California

Status

Withdrawn

Address

University of California San Diego

La Jolla, California, 92093

Site Contact

212-844-6922

George Washington University, Washington, District of Columbia

Status

Recruiting

Address

George Washington University

Washington, District of Columbia, 20037

Site Contact

Jonathan Sherman, MD

jsherman@mfa.gwu.edu

202-741-2750

Delray Medical Center, Delray Beach, Florida

Status

Recruiting

Address

Delray Medical Center

Delray Beach, Florida, 33484

Site Contact

212-844-6922

Atlanta, Georgia

Status

Recruiting

Address

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322

Site Contact

Jeffrey Olson, MD

jolson@emory.edu

404-778-1900

Saint Alphonsus Regional Medical Center, Boise, Idaho

Status

Recruiting

Address

Saint Alphonsus Regional Medical Center

Boise, Idaho, 83706

Site Contact

Terra Inman, BS, CCRC

terra.inman@saintalphonsus.org

208-367-7397

University of Kansas Medical Center, Kansas City, Kansas

Status

Recruiting

Address

University of Kansas Medical Center

Kansas City, Kansas, 66160

Site Contact

212-844-6922

Massachusetts General Hospital, Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Site Contact

Brian Nahed, MD

BNAHED@PARTNERS.ORG

617-724-5805

Henry Ford Hospital, Detroit, Michigan

Status

Recruiting

Address

Henry Ford Hospital

Detroit, Michigan, 48202

Site Contact

212-844-6922

CentraCare St. Cloud Hospital, Saint Cloud, Minnesota

Status

Recruiting

Address

CentraCare St. Cloud Hospital

Saint Cloud, Minnesota, 56303

Site Contact

212-844-6922

Kansas City, Missouri

Status

Completed

Address

St. Luke's Marion Bloch Neuroscience Institute

Kansas City, Missouri, 64111

Site Contact

212-844-6922

Washington University School of Medicine, Saint Louis, Missouri

Status

Recruiting

Address

Washington University School of Medicine

Saint Louis, Missouri, 63110

Site Contact

212-844-6922

Albuquerque, New Mexico

Status

Recruiting

Address

University of New Mexico School of Medicine, Department of Neurosurgery

Albuquerque, New Mexico, 87131

Site Contact

Ronald Mimis, CRC

505-272-3417

Mount Sinai Beth Israel, New York, New York

Status

Completed

Address

Mount Sinai Beth Israel

New York, New York, 10003

Site Contact

212-844-6922

Mount Sinai St Luke's, New York, New York

Status

Withdrawn

Address

Mount Sinai St Luke's

New York, New York, 10025

Site Contact

212-844-6922

Icahn School of Medicine at Mount Sinai, New York, New York

Status

Completed

Address

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

Site Contact

212-844-6922

St. Luke's University Health Network, Bethlehem, Pennsylvania

Status

Recruiting

Address

St. Luke's University Health Network

Bethlehem, Pennsylvania, 18015

Site Contact

Hugh Moulding, MD

Hugh.Moulding@sluhn.org

484-526-6000

Hershey, Pennsylvania

Status

Recruiting

Address

Penn State- Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033

Site Contact

Brad Zacharia, MD

bzacharia@hmc.psu.edu

717-531-4177

Allegheny General Hospital, Pittsburgh, Pennsylvania

Status

Recruiting

Address

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212

Site Contact

Khaled Aziz, MD

kaziz@wpahs.org

412-359-6200

Huntsman Cancer Institute, Salt Lake City, Utah

Status

Recruiting

Address

Huntsman Cancer Institute

Salt Lake City, Utah, 84112

Site Contact

Randy Jensen, MD, PhD

randy.jensen@hsc.utah.edu

801-585-0255

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