Brain NeoplasmsNCT02389530
Use of Fluorescein Dye for the Removal of Brain Tumors
An observational study of Brain Neoplasms, run by University of Pittsburgh at 1 site in United States.
Trial summary
Fluorescein is a dye agent that can be injected through an intravenous line. It has been shown to help tell the difference between brain tumor tissue and normal brain tissue when it is used together with a specialized filter on a microscope in the operating room. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Neoplasms
- What is being tested?
- Fluorescein
- Type of treatment
- Injection or infusion
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Jun 2018
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 18 years of age or above pending elective removal of an intraparenchymal brain tumor.
Who may be able to join
- Age of 18 or greater
- Plan for elective removal of a brain tumor at UPMC Shadyside with either Dr. Engh or Dr. Amankulor.
Who cannot join
- History of adverse reaction to fluorescein.
- Emergent surgical procedure (consent not feasible).
- Creatinine of > 2.0 (drug is excreted renally).
- Known ongoing pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
About this study
Fluorescein is a dye agent that can be injected through an intravenous line. It has been shown to help tell the difference between brain tumor tissue and normal brain tissue when it is used together with a specialized filter on a microscope in the operating room. The investigators plan to study the use of fluorescein in the removal of brain tumors at a low dose.
- Conditions
- Brain Neoplasms
- Being tested
- Fluorescein
- Keywords
- glioma, neoplasms
- Medical subject headings
- Brain Neoplasms, Glioma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluoresceinDrug
Fluorescein will be administered intravenously at a dose between 250 mg and 400 mg in the experimental arm.
| Study group | Role | What they receive |
|---|---|---|
| interventional group | All participants will receive the study intervention, intravenous administration of fluorescein dye prior to brain tumor removal. Receives: Drug: Fluorescein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event assessment
Assessment of frequency of adverse events related to fluorescein administration, especially anaphylaxis
Measured: 3 years
Secondary outcomes (2)
Degree of tumoral resection
Volumetric assessment of amount of tumor removed, compared to historical controls
Measured: 3 years
Clinical status after surgery
Assessment of new deficit in speech, motor function, sensation or vision based on post-operative neurological examination: NIH stroke scale scores will be measured for all participants pre- and post-operatively.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johnathan Engh, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389530
- Sponsor's protocol ID
- PRO14100616
- Status last verified
- Nov 2017
- First submitted
- 3 Mar 2015
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Fluorescein Dye for the Removal of Brain Tumors
- ClinicalTrials.gov ID
- NCT02389530
- Acronym / sponsor ID
- PRO14100616
- Conditions
- Brain Neoplasms
- Keywords
- glioma, neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 17 Mar 2015 (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.
Fluorescein is a dye agent that can be injected through an intravenous line. It has been shown to help tell the difference between brain tumor tissue and normal brain tissue when it is used together with a specialized filter on a microscope in the operating room. The investigators plan to study the use of fluorescein in the removal of brain tumors at a low dose.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| interventional group | – | Drug: FluoresceinAll participants will receive the study intervention, intravenous administration of fluorescein dye prior to brain tumor removal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18 years of age or above pending elective removal of an intraparenchymal brain tumor.
Key inclusion criteria (2 listed)
- Age of 18 or greater
- Plan for elective removal of a brain tumor at UPMC Shadyside with either Dr. Engh or Dr. Amankulor.
Key exclusion criteria (4 listed)
- History of adverse reaction to fluorescein.
- Emergent surgical procedure (consent not feasible).
- Creatinine of > 2.0 (drug is excreted renally).
- Known ongoing pregnancy.
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 |
|---|---|---|
| FluoresceinFluorescein will be administered intravenously at a dose between 250 mg and 400 mg in the experimental arm. | Drug | interventional group |
Primary outcome
Adverse event assessment
Time frame: 3 years
Assessment of frequency of adverse events related to fluorescein administration, especially anaphylaxis
2 secondary outcomes
Degree of tumoral resection
Time frame: 3 years
Clinical status after surgery
Time frame: 3 years
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 3 Aug 2018.
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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.
Johnathan Engh, MD principal investigator
University of Pittsburgh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Neoplasms, run by University of Pittsburgh 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 2 inclusion and 4 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 3 Aug 2018. 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.
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?
Adverse event assessment (time frame: 3 years). 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 3 Aug 2018.