Clinical Trials

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.

Eligibility last updated 6/13/22. Questions regarding updates should be directed to the study team contact.