Brain TumorsPhase 1FGRNCT00870779
Fluorescence Guided Resection of Brain Tumors
A Phase 1 study testing 5-aminolevulinic acid in people with Brain Tumors, run by David W. Roberts at 1 site in United States.
Trial summary
Removing a tumor from your brain is hard to do because, very often, brain tumors do not have boundaries that are easy for your surgeon to find. In many cases, the surgeon can't tell exactly where the tumor begins or ends. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Brain Tumors
- What is being tested?
- 5-aminolevulinic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to 2 Jul 2013
- Phase
- Phase 1
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Preoperative diagnosis of either presumed low or high grade glioma (astrocytoma, oligodendroglioma, mixed oligo-astrocytoma, anaplastic astrocytoma, and glioblastoma multiforme) or meningioma, pituitary adenoma or metastasis.
- Tumor judged to be suitable for open cranial resection based on preoperative imaging studies.
- Patient able to provide written informed consent.
- Age ≥ 21 years old.
Who cannot join
- Pregnant women or women who are breast feeding
- History of cutaneous photosensitivity, porphyria, hypersensitivity to porphyrins, photodermatosis, exfoliative dermatitis
- History of liver disease within the last 12 months,
- AST, ALT, ALP or bilirubin levels greater than 2.5 times the normal limit at any time during the previous 2 months
- Plasma creatinine in excess of 180 mol/L.
- Inability to comply with the photosensitivity precautions associated with the study
- Patients with an existing DSM-IV Axis 1diagnosis
- Inability to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: Co-registered Fluorescence-Enhanced Resection of Brain Tumors Stage I: Correlation With MR and Biopsy
Removing a tumor from your brain is hard to do because, very often, brain tumors do not have boundaries that are easy for your surgeon to find. In many cases, the surgeon can't tell exactly where the tumor begins or ends. The surgeon usually can remove most of your tumor by looking at the MRI images that were taken of your brain before surgery. However, the surgeon does not have any good way to tell if the entire tumor has been removed or not. Removing the entire tumor is very important because leaving tumor behind may allow it to grow back which could decrease your chances of survival.
It is possible to detect tumor cells by making them glow with a specific color of light (a process called fluorescence). This can be done by having you take the drug, ALA, before your surgery. ALA is a molecule that already exists in the cells of your body. Once enough of it is in your body, it gets converted into another molecule named PpIX. If blue light is shined on a tumor that has enough PpIX, it will glow with red light (fluorescence) that can be detected with a special camera. In this study, we want to determine how the fluorescence (red light) is related to the tumor which appears in the images that are normally taken of your brain (which the surgeon uses to guide the removal of your tumor) and the tumor tissue that will be removed during your surgery. Removing the entire tumor is very important because leaving tumor behind may allow it to grow back which could decrease your chances of survival.
Read the detailed description
The first phase of study (Stage I) will use FI coregistered with pMR, iUS and iSV images to test the overall hypothesis that there is a high degree of spatial correlation between local tissue FI signal and coregistered conventional imaging and corresponding histopathology. Additionally, coregistered probe measurements and biopsy specimens will be acquired intraoperatively. Biopsy specimens will be processed post-operatively (via fluorescence microscopy and chemical spectrofluorimetry) to assess PpIX concentration which will allow direct comparisons of FI signal strength with PpIX production (based on both in vivo probe data and ex vivo histological quantification) as a function of histological grade. The study protocol is outlined below. Because of the overall interest and importance of relating this data to the existing body of literature and the excellent safety record of oral administration of ALA reported in these trials [1, 33-36], we will use the same dose/time schedule described in [1, 33]. The operative procedures will follow existing practice at Dartmouth for image-guided resection of meningiomas, pituitary adenomas and metastases with additional acquisition of FI and biopsy data at predefined time points that are related to the expected volume of tumor tissue. In this first phase of the study, resection decisions will not be made based on FI data alone. Should residual fluorescence remain after the intended resection volume has been removed further excisions will require biopsy confirmation in the OR. It is anticipated that 234 patients will be enrolled in Stage I.
- Conditions
- Brain Tumors
- Being tested
- 5-aminolevulinic acid
- Keywords
- Fluorescence, Brain Tumor, Malignant Glioma, Pituitary Tumor, Skull Base Tumor, Brain Lesions, Brain Metastases, Meningioma
- Medical subject headings
- Brain Neoplasms, Glioma, Pituitary Neoplasms, Skull Base Neoplasms, Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-aminolevulinic acidDrug
Also called 5-ALA
20mg/kg 3 hours prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| 5-aminolevulinic acid | Experimental | Not described Receives: Drug: 5-aminolevulinic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the degree of spatial correlation between local fluorescence recorded intraop and coregistered conventional imaging obtained preop with MR and intraop with ultrasound and operating microscope stereovision.
Measured: From date of first surgery through 6/1/2013
Secondary outcomes (1)
Establish the clinical feasibility of integrating FI with conventional image guidance (pMR, iUS and iSV data). Determine the relationships between FI signals, PpIX concentration, histological grade and image features evident for surgical guidance.
Measured: From date of first surgery through 6/1/2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2009 (estimated)
- Study startMay 2007
- Primary completion2 Jul 2012
- Study completion2 Jul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorsStudies 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- David W. Roberts
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David W. Roberts, Dartmouth-Hitchcock Medical Center
- Investigators
- David W Roberts, MD, Principal investigator, Dartmouth-Hitchcock Medical CenterKeith Paulsen, PhD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870779
- Sponsor's protocol ID
- DMS 0711
- Other IDs
- R01NS052274-01A2
- Acronym
- FGR
- Status last verified
- Jun 2019
- First submitted
- 25 Mar 2009
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-registered Fluorescence-Enhanced Resection of Brain Tumors Stage I: Correlation With MR and Biopsy
- ClinicalTrials.gov ID
- NCT00870779
- Acronym / sponsor ID
- FGR / DMS 0711
- Conditions
- Brain Tumors
- Keywords
- Fluorescence, Brain Tumor, Malignant Glioma, Pituitary Tumor, Skull Base Tumor, Brain Lesions, Brain Metastases, Meningioma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- David W. RobertsUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- May 2007
- Primary completion
- 2 Jul 2012 (actual)
- Study completion
- 2 Jul 2013 (actual)
- First posted
- 27 Mar 2009 (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.
Removing a tumor from your brain is hard to do because, very often, brain tumors do not have boundaries that are easy for your surgeon to find. In many cases, the surgeon can't tell exactly where the tumor begins or ends. The surgeon usually can remove most of your tumor by looking at the MRI images that were taken of your brain before surgery. However, the surgeon does not have any good way to tell if the entire tumor has been removed or not. Removing the entire tumor is very important because leaving tumor behind may allow it to grow back which could decrease your chances of survival.
It is possible to detect tumor cells by making them glow with a specific color of light (a process called fluorescence). This can be done by having you take the drug, ALA, before your surgery. ALA is a molecule that already exists in the cells of your body. Once enough of it is in your body, it gets converted into another molecule named PpIX. If blue light is shined on a tumor that has enough PpIX, it will glow with red light (fluorescence) that can be detected with a special camera. In this study, we want to determine how the fluorescence (red light) is related to the tumor which appears in the images that are normally taken of your brain (which the surgeon uses to guide the removal of your tumor) and the tumor tissue that will be removed during your surgery. Removing the entire tumor is very important because leaving tumor behind may allow it to grow back which could decrease your chances of survival.
Detailed description
The first phase of study (Stage I) will use FI coregistered with pMR, iUS and iSV images to test the overall hypothesis that there is a high degree of spatial correlation between local tissue FI signal and coregistered conventional imaging and corresponding histopathology. Additionally, coregistered probe measurements and biopsy specimens will be acquired intraoperatively. Biopsy specimens will be processed post-operatively (via fluorescence microscopy and chemical spectrofluorimetry) to assess PpIX concentration which will allow direct comparisons of FI signal strength with PpIX production (based on both in vivo probe data and ex vivo histological quantification) as a function of histological grade. The study protocol is outlined below. Because of the overall interest and importance of relating this data to the existing body of literature and the excellent safety record of oral administration of ALA reported in these trials [1, 33-36], we will use the same dose/time schedule described in [1, 33]. The operative procedures will follow existing practice at Dartmouth for image-guided resection of meningiomas, pituitary adenomas and metastases with additional acquisition of FI and biopsy data at predefined time points that are related to the expected volume of tumor tissue. In this first phase of the study, resection decisions will not be made based on FI data alone. Should residual fluorescence remain after the intended resection volume has been removed further excisions will require biopsy confirmation in the OR. It is anticipated that 234 patients will be enrolled in Stage I.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 5-aminolevulinic acid | Experimental | Drug: 5-aminolevulinic acid |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Preoperative diagnosis of either presumed low or high grade glioma (astrocytoma, oligodendroglioma, mixed oligo-astrocytoma, anaplastic astrocytoma, and glioblastoma multiforme) or meningioma, pituitary adenoma or metastasis.
- Tumor judged to be suitable for open cranial resection based on preoperative imaging studies.
- Patient able to provide written informed consent.
- Age ≥ 21 years old.
Key exclusion criteria (8 listed)
- Pregnant women or women who are breast feeding
- History of cutaneous photosensitivity, porphyria, hypersensitivity to porphyrins, photodermatosis, exfoliative dermatitis
- History of liver disease within the last 12 months,
- AST, ALT, ALP or bilirubin levels greater than 2.5 times the normal limit at any time during the previous 2 months
- Plasma creatinine in excess of 180 mol/L.
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 |
|---|---|---|
| 5-aminolevulinic acidAlso: 5-ALA20mg/kg 3 hours prior to surgery | Drug | 5-aminolevulinic acid |
Primary outcome
Determine the degree of spatial correlation between local fluorescence recorded intraop and coregistered conventional imaging obtained preop with MR and intraop with ultrasound and operating microscope stereovision.
Time frame: From date of first surgery through 6/1/2013
1 secondary outcome
Establish the clinical feasibility of integrating FI with conventional image guidance (pMR, iUS and iSV data). Determine the relationships between FI signals, PpIX concentration, histological grade and image features evident for surgical guidance.
Time frame: From date of first surgery through 6/1/2013
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 14 Jun 2019.
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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.
David W Roberts, MD principal investigator
Dartmouth-Hitchcock Medical Center
Keith Paulsen, PhD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 5-aminolevulinic acid in people with Brain Tumors, run by David W. Roberts at 1 site in United States.
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 4 inclusion and 8 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 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 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.
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?
Determine the degree of spatial correlation between local fluorescence recorded intraop and coregistered conventional imaging obtained preop with MR and intraop with ultrasound and operating microscope stereovision. (time frame: From date of first surgery through 6/1/2013). 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 14 Jun 2019.