Study on how effective Gleolan is as a maker for tumor cells during brain surgery

Phase 1

Conditions: Meningioma
MedDRA version: 21.1Level: PTClassification code 10027191Term: MeningiomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

Registration Number: EUCTR2020-000096-21-AT

Lead Sponsor: X Development Corp.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

1.A pre-operative MRI within 30 days of study enrollment documenting a suspected meningioma or suspected recurrence of a meningioma for which a 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 canditates per site SOC.
4. Patient must have recording of each Parameter as defined below:
BilirubinBelow upper limit of normal
AST (SGOT)< 2.5 X institutional upper limit of normal
ALT (SGPT)< 2.5 X institutional upper limit of normal
CreatinineBelow upper limit of normal
OR
Creatinine clearance >60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal
5. The Patient/patient´s legally authorized representative (LAR) will have to demonstrate the ability to understand, informed consent, 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.
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

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
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 exculde the patient as a viable candidate for this study
12. Patient undergoing planned embolization prior to meningioma resection that is separate from the meningioma resection procedure itself.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Provide a framework for surgeons to make better-informed decisions during meningioma tumor surgery through the use of Gleolan as a visual aid to distinguish tumor versus non-tumor tissue;Secondary Objective: N/A;Primary end point(s): The percentage of participants who have at least one indeterminate or unexpected fluorescent EOS tissue where Gleolan-induced PpIX fluorescence status is consistent with histology.;Timepoint(s) of evaluation of this end point: Day of surgery

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): PPV of Gleolan-induced PpIX fluorescence of the single bulk tumor biopsied tissue location obtained from each study participant. Study hypothesis: PPV is > 90%;Timepoint(s) of evaluation of this end point: Day of surgery

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