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JOURNAL ONKOLOGIE – STUDIE
MEN-301

Gleolan for Visualization of Newly Diagnosed or Recurrent Meningioma

Rekrutierend

NCT-Nummer:
NCT04305470

Studienbeginn:
Oktober 2020

Letztes Update:
01.04.2021

Wirkstoff:
Gleolan (Aminolevulinic Acid Hydrochloride/ALA/ALA-HCI)

Indikation (Clinical Trials):
Meningioma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
NX Development Corp

Collaborator:
-

Studienleiter

Walter Stummer, MD
Principal Investigator
Universitätsklinikum Münster

Kontakt

Studienlocations
(3 von 10)

Baptist Health South Florida
33176 Miami
United StatesNoch nicht rekrutierend» Google-Maps
Medical University of Vienna
1090 Vienna
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Georg Widhalm, MD
E-Mail: georg.widhalm@meduniwien.ac.at

Julia Freund
E-Mail: julia.freund@meduniwien.ac.at
» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. 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



Secondary outcome:

1. 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

2. 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

3. 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

4. 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

5. 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

Geprüfte Regime

  • Gleolan (Aminolevulinic Acid Hydrochloride/ALA/ALA-HCI):
    One time oral dose on day of surgery (20 mg/kg bodyweight)

Quelle: ClinicalTrials.gov


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