Brain NeoplasmPhase 1/2NCT02755142
Clinical Study on 5-aminolevulinic Acid Hydrochloride (5-ALA) for Fluorescence-guided Resection of Malignant Gliomas
A Phase 1/2 study testing Gliolan in people with Brain Neoplasm, run by medac GmbH.
Trial summary
This study is planned to detect a dose-efficacy relationship between the chosen dose levels of MC506/1 and the extent and quality of fluorescence in the tumour core in patients with newly diagnosed malignant glioma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Neoplasm
- What is being tested?
- Gliolan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Feb 2000to Jun 2001
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- Adult, Older adult
Who may be able to join
- Radiological suspicion of a malignant glioma with distinct ring- or garland shaped, contrast agent-enhancing tumour structures and a core area of reduced intensity in the MRI (tumour necrosis)
- Indication for surgical tumour resection
- First operation of the tumour, no other tumour-specific pre-treatment
- Karnofsky Performance Scale 70%
- Patient's written informed consent
- Age 18-75 years
Who cannot join
- Porphyria, hypersensitivity to porphyrins
- Renal insufficiency:
- Creatinine > 2.0 mg/dl
- Hepatic insufficiency:
- Bilirubin > 3 mg/dl
- Quick test < 60 %
Show all 14Show fewer
- GT > 100 U/I
- Other known malignancy (except basaliomas)
- Women:
- Existing/planned pregnancy (to be checked by a pregnancy test if of child-bearing age)/lactation or inadequate contraception (hormone cycle regulation pill or condom)
- Men:
- Inadequate contraception (condom)
- Dementia or mental condition making it impossible to understand the therapy and therefore prohibiting written consent
- Simultaneous participation or participation in another clinical trial in the preceding 30 days
About this study
Official title: Clinical Phase I/II Study on 5-aminolevulinic Acid Hydrochloride (5-ALA) for Fluorescence-guided Resection of Malignant Gliomas
This study is planned to detect a dose-efficacy relationship between the chosen dose levels of MC506/1 and the extent and quality of fluorescence in the tumour core in patients with newly diagnosed malignant glioma.
- Conditions
- Brain Neoplasm
- Being tested
- Gliolan
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GliolanBiological
Also called 5-Aminolevulinic Acid Hydrochloride (5-ALA)
| Study group | Role | What they receive |
|---|---|---|
| Dose level 1 | Active comparator | 0,2 mg/Kg Receives: Biological: Gliolan |
| Dose level 2 | Active comparator | 2,0 mg/Kg Receives: Biological: Gliolan |
| Dose level 3 | Active comparator | 20 mg/Kg Receives: Biological: Gliolan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of a dose-efficacy relationship between the dose levels and the extent and quality of fluorescence in the tumour core (of newly diagnosed malignant glioma).
After completion of resection, global fluorescence extent in the tumour core will be assessed by the first and second surgeon. It will be estimated whether approx. 0/3, 1/3, 2/3 or 3/3 of the tumour core is identified using standard white operation light were fluorescent (irrespective of fluorescence quality). The global quality of Gliolan induced tissue fluorescence within the tumour core will be recorded as being strong, weak or missing. As an objective control of the subjective assessment of the fluorescent quality, selected areas will be measured spectrometrically.
Measured: Within 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study startFeb 2000
- Primary completionJun 2001
- Study completionJun 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain NeoplasmStudies 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 1/2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- medac GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IKP
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755142
- Sponsor's protocol ID
- MC-ALS.8-I/GLI
- Status last verified
- Apr 2016
- First submitted
- 22 Apr 2016
- Last updated
- 23 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Phase I/II Study on 5-aminolevulinic Acid Hydrochloride (5-ALA) for Fluorescence-guided Resection of Malignant Gliomas
- ClinicalTrials.gov ID
- NCT02755142
- Acronym / sponsor ID
- MC-ALS.8-I/GLI
- Conditions
- Brain Neoplasm
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- medac GmbHIndustry (pharma, biotech, devices)
- Collaborators
- IKP
- Study start
- Feb 2000
- Primary completion
- Jun 2001 (actual)
- Study completion
- Jun 2001 (actual)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is planned to detect a dose-efficacy relationship between the chosen dose levels of MC506/1 and the extent and quality of fluorescence in the tumour core in patients with newly diagnosed malignant glioma.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose level 1 | Active comparator | Biological: Gliolan0,2 mg/Kg |
| Dose level 2 | Active comparator | Biological: Gliolan2,0 mg/Kg |
| Dose level 3 | Active comparator | Biological: Gliolan20 mg/Kg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Radiological suspicion of a malignant glioma with distinct ring- or garland shaped, contrast agent-enhancing tumour structures and a core area of reduced intensity in the MRI (tumour necrosis)
- Indication for surgical tumour resection
- First operation of the tumour, no other tumour-specific pre-treatment
- Karnofsky Performance Scale 70%
- Patient's written informed consent
Key exclusion criteria (14 listed)
- Porphyria, hypersensitivity to porphyrins
- Renal insufficiency:
- Hepatic insufficiency:
- Other known malignancy (except basaliomas)
- Existing/planned pregnancy (to be checked by a pregnancy test if of child-bearing age)/lactation or inadequate contraception (hormone cycle regulation pill or condom)
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 |
|---|---|---|
| GliolanAlso: 5-Aminolevulinic Acid Hydrochloride (5-ALA) | Biological | Dose level 1, Dose level 2, Dose level 3 |
Primary outcome
Detection of a dose-efficacy relationship between the dose levels and the extent and quality of fluorescence in the tumour core (of newly diagnosed malignant glioma).
Time frame: Within 3 hours
After completion of resection, global fluorescence extent in the tumour core will be assessed by the first and second surgeon. It will be estimated whether approx. 0/3, 1/3, 2/3 or 3/3 of the tumour core is identified using standard white operation light were fluorescent (irrespective of fluorescence quality). The global quality of Gliolan induced tissue fluorescence within the tumour core will be recorded as being strong, weak or missing. As an objective control of the subjective assessment of the fluorescent quality, selected areas will be measured spectrometrically.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gliolan in people with Brain Neoplasm, run by medac GmbH.
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 6 inclusion and 14 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 23 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Detection of a dose-efficacy relationship between the dose levels and the extent and quality of fluorescence in the tumour core (of newly diagnosed malignant glioma). (time frame: Within 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2016.