MeningiomaPhase 3MEN-301NCT04305470
Gleolan for Visualization of Newly Diagnosed or Recurrent Meningioma
A Phase 3 study testing Gleolan in people with Meningioma, run by NX Development Corp at 17 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meningioma
- What is being tested?
- Gleolan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 17 sitesin 3 countries
- Study dates
- 28 Oct 2020to 13 Dec 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A pre-operative MRI within ≤ 90 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.
- Adult age ≥ 18 years.
- Patient must have normal organ and bone marrow function and be appropriate surgical candidates per site SOC.
- 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
- 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.
- 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.
Who cannot join
- History of allergic reactions attributed to compounds of similar chemical/biologic composition to Gleolan.
- Known or documented personal or family history of porphyria.
- Uncontrolled concurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness.
- Patient has had a meningioma resection or radiation treatment within 90 days of informed consent.
- 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).
- Women who are pregnant or plan to become pregnant during study participation.
Show all 11Show fewer
- Prior history of gastrointestinal perforation, diverticulitis, and or/peptic ulcer disease within 90 days of informed consent.
- 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.
- 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).
- Unwillingness by patient to sign consent or return for subsequent visits following surgery.
- Any condition that in the opinion of the Investigator would exclude the patient as a viable candidate for this study.
Trial locations and contacts
17 sites in 3 countries.
17 sites in 3 countries
United States15 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
NYU Langone Health
Brooklyn, New York, 11220
University of Miami
Coral Gables, Florida, 33136
Henry Ford Health System
Detroit, Michigan, 48202
Swedish Medical Center
Englewood, Colorado, 80113
MD Anderson
Houston, Texas, 77030
University of California San Diego
La Jolla, California, 92093
Keck Hospital of USC
Los Angeles, California, 90033
Baptist Health South Florida
Miami, Florida, 33176
Providence St. Joseph Hospital
Orange, California, 92868
University of Pennsylvania- Penn Medicine
Philadelphia, Pennsylvania, 19104
Mayo Clinic
Phoenix, Arizona, 85054
UPMC
Pittsburgh, Pennsylvania, 15213
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Southern Illinois University
Springfield, Illinois, 62702
About this study
Official title: A Phase 3 Multicenter Study of Gleolan (Aminolevulinic Acid Hydrochloride) to Enhance Visualization of Tumor in Patients With Newly Diagnosed or Recurrent Meningiomas
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.
Read the 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.
- Conditions
- Meningioma
- Being tested
- Gleolan
- Keywords
- ALA, fluorescence guided surgery, Gleolan, meningioma
- Medical subject headings
- Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GleolanDrug
Also called Aminolevulinic Acid Hydrochloride / ALA / ALA HCI
One time oral dose on day of surgery (20 mg/kg bodyweight)
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Open-label, intra-subject control Receives: Drug: Gleolan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Participants Who Had at Least 1 Indeterminate Tissue or Unexpected Fluorescent End of Surgery (EOS) Tissue Where Gleolan-induced PpIX Fluorescence Status is Consistent With Histology (i.e., True Positive or True Negative for Meningioma).
Responders are defined as the percentage of participants among all participants receiving Gleolan (the Intent to Image Population) who had at least one indeterminate tissue or unexpected fluorescent end of surgery (EOS) tissue where Gleolan-induced PpIX fluorescence status was consistent with central laboratory histology. For a participant to be considered a success, only biopsies considered 'non-obvious' for tumor status by an external panel of neurosurgeons who reviewed videos and images were eligible to be assessed in the numerator. A two-sided 95% confidence interval was calculated using the Wilson (score) method. The lower bound of the confidence interval was tested against a null hypothesis value of 30%. A modified worst-case imputation was used for missing data.
Measured: Surgery (Day 1)
Secondary outcomes (3)
Positive Predicted Value (PPV) of Gleolan-induced PpIX Fluorescence Status of Biopsied Tissue Locations at the Margin of the Tumor [Indeterminate Tissues and Unexpected Fluorescent EOS Tissues (Combined)].
PPV calculation considers both indeterminate and unexpected fluorescent end-of-surgery tissues. Generalized Estimating Equation (GEE) models that take into account the correlation (clustering) of the biopsies within a participant were used to calculate the estimates and two-sided 95% confidence intervals. The models used a binomial distribution function with an exchangeable working correlation matrix and utilized a robust variance estimator. PPV = TP/(TP+FP) TP = True Positive; FP = False Positive; The truth standard was determined via central histopathology.
Measured: Surgery (Day 1)
Negative Predicted Value (NPV) of Gleolan-induced PpIX Fluorescence Status of Biopsied Tissue Locations at the Margin of the Tumor [Indeterminate Tissues].
NPV calculation considered indeterminate tissues only since unexpected fluorescent end-of-surgery tissues were, by definition, fluorescence positive. Generalized Estimating Equation (GEE) models that take into account the correlation (clustering) of the biopsies within a participant were used to calculate the estimates and two-sided 95% confidence intervals. The models used a binomial distribution function with an exchangeable working correlation matrix and utilized a robust variance estimator. NPV = TN/(TN+FN) TN = True Negative; FN = False Negative; The truth standard was determined via central histopathology.
Measured: Surgery (Day 1)
Positive Predictive Value of Single Bulk Tumor Sample Obtained From Each Participant.
PPV (PPV=TP/(TP+FP)) of Gleolan-induced PpIX fluorescence status of biopsied tissue locations of bulk/core meningioma tumor
Measured: Surgery (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2020
- Study start28 Oct 2020
- Primary completion7 Nov 2022
- Study completion13 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MeningiomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase 3, open-label, single arm study.
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- NX Development Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Walter Stummer, MD, Principal investigator, Universitätsklinikum MünsterBernard Bendok, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04305470
- Sponsor's protocol ID
- NXDC-MEN-301
- Acronym
- MEN-301
- Status last verified
- Apr 2026
- First submitted
- 9 Mar 2020
- Last updated
- 18 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stummer W, Holling M, Bendok BR, Vogelbaum MA, Cox A, Renfrow SL, Widhalm G, Ezrin A, DeSena S, Sackman ML, Wyse JW. The NXDC-MEN-301 Study on 5-ALA for Meningiomas Surgery: An Innovative Study Design for the Assessing the Benefit of Intra-Operative Fluorescence Imaging. Brain Sci. 2022 Aug 6;12(8):1044. doi: 10.3390/brainsci12081044.
PubMed 36009108
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Multicenter Study of Gleolan (Aminolevulinic Acid Hydrochloride) to Enhance Visualization of Tumor in Patients With Newly Diagnosed or Recurrent Meningiomas
- ClinicalTrials.gov ID
- NCT04305470
- Acronym / sponsor ID
- MEN-301 / NXDC-MEN-301
- Conditions
- Meningioma
- Keywords
- ALA, fluorescence guided surgery, Gleolan, meningioma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- NX Development CorpIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 7 Nov 2022 (actual)
- Study completion
- 13 Dec 2022 (actual)
- First posted
- 12 Mar 2020 (actual)
- Results
- Posted 18 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase 3, open-label, single arm study.
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: GleolanOpen-label, intra-subject control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A pre-operative MRI within ≤ 90 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.
- Adult age ≥ 18 years.
- Patient must have normal organ and bone marrow function and be appropriate surgical candidates per site SOC.
- 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
Key exclusion criteria (11 listed)
- History of allergic reactions attributed to compounds of similar chemical/biologic composition to Gleolan.
- Known or documented personal or family history of porphyria.
- Uncontrolled concurrent illness, including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness.
- Patient has had a meningioma resection or radiation treatment within 90 days of informed consent.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GleolanAlso: Aminolevulinic Acid Hydrochloride / ALA / ALA HCIOne time oral dose on day of surgery (20 mg/kg bodyweight) | Drug | Single Arm |
Primary outcome
The Percentage of Participants Who Had at Least 1 Indeterminate Tissue or Unexpected Fluorescent End of Surgery (EOS) Tissue Where Gleolan-induced PpIX Fluorescence Status is Consistent With Histology (i.e., True Positive or True Negative for Meningioma).
Time frame: Surgery (Day 1)
Responders are defined as the percentage of participants among all participants receiving Gleolan (the Intent to Image Population) who had at least one indeterminate tissue or unexpected fluorescent end of surgery (EOS) tissue where Gleolan-induced PpIX fluorescence status was consistent with central laboratory histology. For a participant to be considered a success, only biopsies considered 'non-obvious' for tumor status by an external panel of neurosurgeons who reviewed videos and images were eligible to be assessed in the numerator. A two-sided 95% confidence interval was calculated using the Wilson (score) method. The lower bound of the confidence interval was tested against a null hypothesis value of 30%. A modified worst-case imputation was used for missing data.
3 secondary outcomes
Positive Predicted Value (PPV) of Gleolan-induced PpIX Fluorescence Status of Biopsied Tissue Locations at the Margin of the Tumor [Indeterminate Tissues and Unexpected Fluorescent EOS Tissues (Combined)].
Time frame: Surgery (Day 1)
Negative Predicted Value (NPV) of Gleolan-induced PpIX Fluorescence Status of Biopsied Tissue Locations at the Margin of the Tumor [Indeterminate Tissues].
Time frame: Surgery (Day 1)
Positive Predictive Value of Single Bulk Tumor Sample Obtained From Each Participant.
Time frame: Surgery (Day 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 36009108Stummer W, Holling M, Bendok BR, Vogelbaum MA, Cox A, Renfrow SL, Widhalm G, Ezrin A, DeSena S, Sackman ML, Wyse JW. The NXDC-MEN-301 Study on 5-ALA for Meningiomas Surgery: An Innovative Study Design for the Assessing the Benefit of Intra-Operative Fluorescence Imaging. Brain Sci. 2022 Aug 6;12(8):1044. doi: 10.3390/brainsci12081044.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter Stummer, MD principal investigator
Universitätsklinikum Münster
Bernard Bendok, MD principal investigator
Mayo Clinic
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gleolan in people with Meningioma, run by NX Development Corp at 17 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Austria, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Percentage of Participants Who Had at Least 1 Indeterminate Tissue or Unexpected Fluorescent End of Surgery (EOS) Tissue Where Gleolan-induced PpIX Fluorescence Status is Consistent With Histology (i.e., True Positive or True Negative for Meningioma). (time frame: Surgery (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04305470, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.