High Grade Malignant NeoplasmNCT02540135
Fluorescein vs. iMRI in Resection of Malignant High Grade Glioma
A study testing fluorescein and intraoperative MRI in people with High Grade Malignant Neoplasm and Glioblastoma Multiforme, run by University of Colorado, Denver at 1 site in United States.
Trial summary
This study plans to learn more about if fluorescein with intraoperative Magnetic Resonance Imaging (MRI) is as good as intraoperative MRI (iMRI) alone in detecting the presence of tumor tissue during surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Grade Malignant Neoplasm, Glioblastoma Multiforme, Anaplastic Astrocytoma
- What is being tested?
- fluorescein and intraoperative MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2015to 18 Jul 2018
- Phase
- Interventional
- 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
Who may be able to join
- Presents with presumed or pathologically proven enhancing primary or secondary high grade glioma for surgical resection
- Eligible for gross total resection of enhancing component of tumor
- Karnofsy performance status >/= 70%
Who cannot join
- Presence of multi-focal disease
- Disease that crosses the mid-line
- History of adverse reaction to flourescein
- Known ongoing pregnancy
- Inability to grant consent
- Contraindication to perform iMRI
- Contraindication to flourescein
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: Fluorescein vs. Intraoperative MRI in the Resection of Malignant High Grade Glioma
This study plans to learn more about if fluorescein with intraoperative Magnetic Resonance Imaging (MRI) is as good as intraoperative MRI (iMRI) alone in detecting the presence of tumor tissue during surgery.
Both fluorescein and intraoperative MRI have been studied and routinely used to aid the neurosurgeon in distinguishing normal brain from tumor, helping the neurosurgeon to safely resect more tumor tissue during surgery.
Read more
This study will enroll patients with malignant high grade glioma who are going to have a surgery to remove their brain tumor.
For half of the patients, fluorescein and intraoperative MRI will be used together during surgery. For half of the patients, only intraoperative MRI will be used during surgery. iMRI is used as final verification of complete, safe resection in both arms.
Read the detailed description
Extent of surgical resection of malignant high grade glioma has been established as one of the most important predictors of overall survival and six-month progression free survival. Unfortunately, it is often difficult in surgery to distinguish between tumor and normal brain. Various technologies have been developed to help the surgeon more readily safely increase extent of resection in order to achieve an improved survival after glioblastoma resection. Fluorescein has been used at some institutions for a number of years to improve visualization of high-grade gliomas enabling their better resection. Intraoperative MRI has also been developed with similar intent, allowing the patient to be imaged intraoperatively to determine extent of resection and any need for further resection prior to leaving the operating room. While there is some evidence these technologies improve extent of resection in comparison to historical controls, they have never been tested against each other in any prospective fashion.
Intraoperative MRI has significant cost and significantly increases operative time. Fluorescein is a very inexpensive injectable agent and, if as good at achieving gross total resection as intraoperative MRI, would offer patients similar surgical outcomes with less anesthetic time and cost than intraoperative MRI. This study aims to investigate the value of fluorescein or intraoperative MRI in malignant glioma patients' extent of tumor resection in a prospectively randomized manner.
- Being tested
- fluorescein, intraoperative MRI
- Keywords
- high grade glioma, glioblastoma multiforme, anaplastic astrocytoma, flourescein, flourescence-guided surgery, intraoperative MRI, iMRI
- Medical subject headings
- Glioblastoma, Astrocytoma, Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluoresceinOther
fluorescein and conventional neuro-navigation
intraoperative MRIOther
Also called iMRI
conventional neuro-navigation and iMRI
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Flourescein plus intraoperative MRI Receives: Other: fluorescein; Other: intraoperative MRI |
| Arm B | Active comparator | intraoperative MRI alone Receives: Other: intraoperative MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of resection
This outcome will utilize tumor volumetry of residual enhancing tumor after resection.
Measured: 36 hours
Secondary outcomes (1)
Surgical time difference
This outcome will evaluate the difference in length of surgery time between each arm.
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study start1 Mar 2015 (estimated)
- Primary completion18 Jul 2018
- Study completion18 Jul 2018
Why it stopped: The investigators decided not to move forward with this study at this time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Grade Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David R Ormond, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540135
- Sponsor's protocol ID
- 15-1313
- Status last verified
- Jul 2018
- First submitted
- 1 Sep 2015
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorescein vs. Intraoperative MRI in the Resection of Malignant High Grade Glioma
- ClinicalTrials.gov ID
- NCT02540135
- Acronym / sponsor ID
- 15-1313
- Keywords
- high grade glioma, glioblastoma multiforme, anaplastic astrocytoma, flourescein, flourescence-guided surgery, intraoperative MRI, iMRI
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The investigators decided not to move forward with this study at this time.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 1 Mar 2015 (estimated)
- Primary completion
- 18 Jul 2018 (actual)
- Study completion
- 18 Jul 2018 (actual)
- First posted
- 3 Sep 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.
This study plans to learn more about if fluorescein with intraoperative Magnetic Resonance Imaging (MRI) is as good as intraoperative MRI (iMRI) alone in detecting the presence of tumor tissue during surgery.
Both fluorescein and intraoperative MRI have been studied and routinely used to aid the neurosurgeon in distinguishing normal brain from tumor, helping the neurosurgeon to safely resect more tumor tissue during surgery.
This study will enroll patients with malignant high grade glioma who are going to have a surgery to remove their brain tumor.
For half of the patients, fluorescein and intraoperative MRI will be used together during surgery. For half of the patients, only intraoperative MRI will be used during surgery. iMRI is used as final verification of complete, safe resection in both arms.
Detailed description
Extent of surgical resection of malignant high grade glioma has been established as one of the most important predictors of overall survival and six-month progression free survival. Unfortunately, it is often difficult in surgery to distinguish between tumor and normal brain. Various technologies have been developed to help the surgeon more readily safely increase extent of resection in order to achieve an improved survival after glioblastoma resection. Fluorescein has been used at some institutions for a number of years to improve visualization of high-grade gliomas enabling their better resection. Intraoperative MRI has also been developed with similar intent, allowing the patient to be imaged intraoperatively to determine extent of resection and any need for further resection prior to leaving the operating room. While there is some evidence these technologies improve extent of resection in comparison to historical controls, they have never been tested against each other in any prospective fashion.
Intraoperative MRI has significant cost and significantly increases operative time. Fluorescein is a very inexpensive injectable agent and, if as good at achieving gross total resection as intraoperative MRI, would offer patients similar surgical outcomes with less anesthetic time and cost than intraoperative MRI. This study aims to investigate the value of fluorescein or intraoperative MRI in malignant glioma patients' extent of tumor resection in a prospectively randomized manner.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Other: fluorescein, Other: intraoperative MRIFlourescein plus intraoperative MRI |
| Arm B | Active comparator | Other: intraoperative MRIintraoperative MRI alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presents with presumed or pathologically proven enhancing primary or secondary high grade glioma for surgical resection
- Eligible for gross total resection of enhancing component of tumor
- Karnofsy performance status >/= 70%
Key exclusion criteria (7 listed)
- Presence of multi-focal disease
- Disease that crosses the mid-line
- History of adverse reaction to flourescein
- Known ongoing pregnancy
- Inability to grant consent
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 and conventional neuro-navigation | Other | Arm A |
| intraoperative MRIAlso: iMRIconventional neuro-navigation and iMRI | Other | Arm A, Arm B |
Primary outcome
Extent of resection
Time frame: 36 hours
This outcome will utilize tumor volumetry of residual enhancing tumor after resection.
1 secondary outcome
Surgical time difference
Time frame: 36 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 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.
David R Ormond, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fluorescein and intraoperative MRI in people with High Grade Malignant Neoplasm and Glioblastoma Multiforme, run by University of Colorado, Denver 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 3 inclusion and 7 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: withdrawn, as of the sponsor's last update on 20 Jul 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 was withdrawn before enrolling participants, so there are no results.
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?
Extent of resection (time frame: 36 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 20 Jul 2018.