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Trial record 1 of 2 for:    Recruiting Studies | Interventional Studies | Meningioma | United States | Start date from 10/09/2020 to 01/05/2021
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Gleolan for Visualization of Newly Diagnosed or Recurrent Meningioma (MEN-301)

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ClinicalTrials.gov Identifier: NCT04305470
Recruitment Status : Recruiting
First Posted : March 12, 2020
Last Update Posted : July 16, 2021
Sponsor:
Information provided by (Responsible Party):
NX Development Corp

Tracking Information
First Submitted Date  ICMJE March 9, 2020
First Posted Date  ICMJE March 12, 2020
Last Update Posted Date July 16, 2021
Actual Study Start Date  ICMJE October 28, 2020
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2020)
The proportion of participants who have at least one indeterminate tissue or unexpected fluorescent End of Surgery (EOS) tissue where Gleolan-induced PpIX fluorescence status is consistent with histology. [ Time Frame: Surgery (Day 1) ]
Per Protocol Population
Original Primary Outcome Measures  ICMJE
 (submitted: March 9, 2020)
Proportion of participants for which Gleolan-induced PpIX fluorescence allows the surgeon to visually obtain correct information as to the presence or absence of tumor in tissue where there is uncertainty based on WL visualization alone. [ Time Frame: Surgery (Day 1) ]
Per Protocol Population
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2020)
  • Positive Predicted Value (PPV) of Gleolan-induced PpIX fluorescence of the single bulk tumor tissue obtained from each study participant [ Time Frame: Surgery (Day 1) ]
    Per Protocol Population
  • Diagnostic accuracy of Gleolan-induced PpIX fluorescence among indeterminate tissue and unexpected fluorescent EOS tissue locations is at least 20% greater than the diagnostic accuracy of the surgeons' assessment. [ Time Frame: Surgery (Day 1) ]
    Biopsy Efficacy Analysis Population
  • Diagnostic performance of Gleolan-induced PpIX fluorescence will be computed for indeterminate tissue biopsies, unexpected fluorescent EOS tissue biopsies. [ Time Frame: Surgery (Day 1) ]
    Biopsy Efficacy Analysis Population
  • The concordance between the Surgeon and Adjudication Panel assessment of white light (WL) visualization visualization to identify tissue as likely or unlikely to be meningioma among indeterminate tissues. [ Time Frame: Surgery (Day 1) ]
    Biopsy Efficacy Analysis Population
  • The concordance between the Surgeon and Adjudication Panel assessment of blue light (BL) visualization to identify fluorescence status of indeterminate tissues. [ Time Frame: Surgery (Day 1) ]
    Biopsy Efficacy Analysis Population
Original Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2020)
  • Diagnostic performance of Gleolan for the real-time visualization of newly diagnosed or recurrent meningioma during resection surgery. [ Time Frame: Surgery (Day 1) ]
    Per Protocol Population
  • Diagnostic accuracy of meningioma identification with Gleolan-induced PpIX fluorescence status under BL vs. visualization under WL among indeterminate tissue and unexpected fluorescent EOS tissue locations. [ Time Frame: Surgery (Day 1) ]
    Biopsy Efficacy Analysis Population
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gleolan for Visualization of Newly Diagnosed or Recurrent Meningioma
Official Title  ICMJE A Phase 3 Multicenter Study of Gleolan (Aminolevulinic Acid Hydrochloride) to Enhance Visualization of Tumor in Patients With Newly Diagnosed or Recurrent Meningiomas
Brief Summary This Phase 3 open-label single-arm study is designed to investigate the safety, diagnostic performance, and clinical usefulness of Gleolan for the real time detection and visualization of meningiomas during tumor resection surgery. The study is planned to run for 15 months with individual study participation lasting for approximately 2 months.
Detailed Description

This Phase 3 open-label single-arm study is designed to investigate the safety, diagnostic performance, and clinical usefulness of the imaging agent Gleolan™ (Aminolevulinic Acid Hydrochloride, ALA HCl, ALA, 5-ALA), an orally administered imaging agent for the real time detection and visualization of meningiomas during tumor resection surgery. ALA is a prodrug that is metabolized intracellularly to form the fluorescent molecule Protoporphyrin IX (PpIX). The exogenous application of ALA leads to a highly selective accumulation of PpIX in tumor cells. Following excitation with blue light (BL) (λ = 375 - 440 nm), the PpIX, which has accumulated selectively in tumor tissue, emits a red-violet light. This phenomenon allows for the real-time visualization of tumor tissue during resection surgery.

Patients about to undergo resection for suspected meningioma [World Health Organization (WHO) Grade I, II, III] will be screened and informed consent will be obtained prior to surgery and prior to study participation. Eligible study participants will receive an oral solution of Gleolan (20 mg/kg body weight) 3 hours, (target range 2-4 hours) prior to anesthesia, and then undergo surgery for meningioma resection. During the surgery, the surgeon will use a microscope equipped with WL and BL for visualization of Gleolan-induced PpIX fluorescence for the selection of protocol-driven tissue locations and to assess fluorescence status.

Study participants will be evaluated within 48 hours post procedure, 2 weeks post procedure, and 6 weeks post procedure for study safety assessment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Phase 3, open-label, single arm study.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Meningioma
Intervention  ICMJE Drug: Gleolan (Aminolevulinic Acid Hydrochloride/ALA/ALA-HCI)
One time oral dose on day of surgery (20 mg/kg bodyweight)
Study Arms  ICMJE Experimental: Single Arm
Open-label, single-arm
Intervention: Drug: Gleolan (Aminolevulinic Acid Hydrochloride/ALA/ALA-HCI)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 9, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2022
Estimated Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. A pre-operative MRI within ≥ 90 days of study enrollment documenting a suspected meningioma or suspected recurrence of a meningioma for which a complete meningioma resection is indicated and has been planned.
  2. Adult age ≥ 18 years.
  3. Patient must have normal organ and bone marrow function and be appropriate surgical candidates per site SOC.
  4. Patient must have recording of each parameter as defined below:

    Bilirubin Below upper limit of normal AST (SGOT) < 2.5 X institutional upper limit of normal 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 participants with creatinine levels above institutional normal

  5. The patient must demonstrate the ability to understand the informed consent document and the willingness and ability to sign a written informed consent document. The study consent documents will be prepared in English and German and Spanish. Translation for non-English, non-German, or non-Spanish speaking participants will be provided as appropriate by institution, as required.
  6. WOCBP and men participating must agree to use highly effective forms of contraception, and men must also agree not to donate sperm for the duration of treatment, and for at least 42 days after the one time use of the study drug.

Exclusion Criteria:

  1. History of allergic reactions attributed to compounds of similar chemical/biologic composition to Gleolan.
  2. Known or documented personal or family history of porphyria.
  3. Uncontrolled concurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness.
  4. Patient has had a meningioma resection or radiation treatment within 90 days of informed consent.
  5. Social or medical situations that would limit compliance with study requirements (e.g. ability to travel for follow-up or inability to obtain appropriate pre-op MRI (e.g. cardiac pacemaker).
  6. Women who are pregnant or plan to become pregnant during study participation.
  7. Prior history of gastrointestinal perforation, diverticulitis, and or/peptic ulcer disease.
  8. Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding treatment or within 5 plasma half-life of the preceding study drug, whatever is longer.
  9. Simultaneous use of other potentially phototoxic substances (St. John's wort, griseofulvin, thiazide diuretics, sulfonylureas, phenothiazines, sulphonamides, quinolones and tetracyclines), and topical preparations containing ALA for 24 hours during the perioperative period (see MOPS for detailed list).
  10. Unwillingness by patient to sign consent or return for subsequent visits following surgery.
  11. Any condition that in the opinion of the Investigator would exclude the patient as a viable candidate for this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ashley Cox, MBA, CCRP 502-316-8981 acox@nxdevcorp.com
Contact: Kelly Sims, CRN, SCRN 267-977-7870 ksims@nxdevcorp.com
Listed Location Countries  ICMJE United States,   Austria,   Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04305470
Other Study ID Numbers  ICMJE NXDC-MEN-301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NX Development Corp
Study Sponsor  ICMJE NX Development Corp
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Walter Stummer, MD Universitätsklinikum Münster
Principal Investigator: Bernard Bendok, MD Mayo Clinic
PRS Account NX Development Corp
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP