Brain Tumor AdultEarly Phase 1NCT03542409
Safety and Feasibility of Preoperative and Intraoperative Image-Guided Resection of Gliomas
A Early Phase 1 study testing MR Perfusion Scan and 2HG Spectroscopy Scan in people with Brain Tumor Adult, run by University of Utah at 1 site in United States.
Trial summary
This study evaluates the use of specialized magnetic resonance imaging (MRI) techniques including magnetic resonance (MR) perfusion and 2-hydroxyglutarate (2HG) spectroscopy in the surgical treatment of gliomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor Adult
- What is being tested?
- MR Perfusion Scan and 2HG Spectroscopy Scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2017to 14 May 2025
- Phase
- Early 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Suspected glioma (grade II, III, or IV)
- Preoperative MR perfusion (enhancing tumors)
- Preoperative MR 2-HG spectroscopy (nonenhancing tumors)
- Patient indicated for surgical resection, standard radiation, and standard chemotherapy as a standard of care
- Karnofsky performance status ≥ 60
Show all 9Show fewer
- Life expectancy > 12 weeks
- Cohort 1: Ability to comply with study and follow-up procedures
- Cohort 2: Ability to comply with study procedures
Who cannot join
- Prior diagnosis of intracranial glioma
- Other malignancy with expected need for systemic therapy within 3 years
- Inability to have 6000 grays of radiation to the brain
- Need for urgent palliative intervention for primary disease (e.g., impending herniation)
- Evidence of bleeding diathesis or coagulopathy
- History of intracerebral abscess within 6 months prior to Day 0
Show all 9Show fewer
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
- Pregnant females
- Subjects unable to undergo an MRI with contrast
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
Official title: Assessment of Safety and Feasibility of Preoperative and Intraoperative Image-Guided Resection of Gliomas and Tumor Region-Specific Biomarker Correlation
This study evaluates the use of specialized magnetic resonance imaging (MRI) techniques including magnetic resonance (MR) perfusion and 2-hydroxyglutarate (2HG) spectroscopy in the surgical treatment of gliomas.
Cohort 1 participants will undergo an MR perfusion scan or 2-HG spectroscopy prior to surgery and intra-operatively.
Cohort 2 participants will only undergo standard of care imaging and tumor acquisition. Participant participation will end at the completion of surgery and will be transitioned to standard of care follow-up.
- Conditions
- Brain Tumor Adult
- Being tested
- MR Perfusion Scan, 2HG Spectroscopy Scan, Standard of Care Intraoperative MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR Perfusion ScanDevice
MR perfusion scan before and during surgery.
2HG Spectroscopy ScanDevice
2HG spectroscopy scan before and during surgery.
Standard of Care Intraoperative MRIDevice
The standard of care intraoperative MRI sequences used routinely will be sufficient for these 10 new samples.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1, Group A (contrast enhancing tumor) | Experimental | Group A patients will undergo standard tumor preoperative imaging and MR perfusion scan prior to surgical resection. Group A patients will undergo standard intraoperative imaging along with MR perfusion scan during surgical resection. Receives: Device: MR Perfusion Scan |
| Cohort 1, Group B (non-enhancing tumor) | Experimental | Group B patients will undergo standard tumor preoperative imaging and 2HG spectroscopy scan prior to surgical resection. Group A patients will undergo standard intraoperative imaging along with 2HG spectroscopy scan during surgical resection. Receives: Device: 2HG Spectroscopy Scan |
| Cohort 2 | Experimental | During the analysis for cohort 1, we found significant differences in the pre MRI samples and the post intraoperative MRI samples. Cohort 2, which will include 10 additional patients, has be created to confirm these differences. Unlike cohort 1, advanced imaging (2-HG spectroscopy and MR perfusion) is not needed to make this comparison. The standard of care intraoperative MRI sequences used routinely will be sufficient for these 10 new samples. The specific aim of Cohort 2 is:
1. Compare areas from initial surgery with that of extended resection after intraoperative SOC MRI in 10 additional subjects (Cohort 2). Receives: Device: Standard of Care Intraoperative MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Imaging Completion
This is a feasibility study to see whether advanced imaging modalities can be used intraoperatively so the primary outcome is a yes/no regarding completion of imaging.
Measured: 1 day
Incidence of Patient Complications Following Tumor Resection
Any surgical complications at post-op, hospital discharge, 1-month, 3-months, 6-months, and 1 year following surgery using the Common Terminology Criteria for Adverse Events (CTCAE)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2018
- Study start15 Feb 2017
- Primary completion28 Oct 2021
- Study completion14 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (42)Papers the sponsor has linked to this study.
- Other trials for Brain Tumor AdultStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Randy Jensen, MD, PhD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03542409
- Sponsor's protocol ID
- 77238
- Status last verified
- Aug 2026
- First submitted
- 1 May 2018
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Jensen RL, Mumert ML, Gillespie DL, Kinney AY, Schabel MC, Salzman KL. Preoperative dynamic contrast-enhanced MRI correlates with molecular markers of hypoxia and vascularity in specific areas of intratumoral microenvironment and is predictive of patient outcome. Neuro Oncol. 2014 Jan;16(2):280-91. doi: 10.1093/neuonc/not148. Epub 2013 Dec 4.
PubMed 24305704Chen R, Ravindra VM, Cohen AL, Jensen RL, Salzman KL, Prescot AP, Colman H. Molecular features assisting in diagnosis, surgery, and treatment decision making in low-grade gliomas. Neurosurg Focus. 2015 Mar;38(3):E2. doi: 10.3171/2015.1.FOCUS14745.
PubMed 25727224Karsy M, Neil JA, Guan J, Mahan MA, Colman H, Jensen RL. A practical review of prognostic correlations of molecular biomarkers in glioblastoma. Neurosurg Focus. 2015 Mar;38(3):E4. doi: 10.3171/2015.1.FOCUS14755.
PubMed 25727226Huse JT, Holland EC. Targeting brain cancer: advances in the molecular pathology of malignant glioma and medulloblastoma. Nat Rev Cancer. 2010 May;10(5):319-31. doi: 10.1038/nrc2818.
PubMed 20414201Karsy M, Huang T, Kleinman G, Karpel-Massler G. Molecular, histopathological, and genomic variants of glioblastoma. Front Biosci (Landmark Ed). 2014 Jun 1;19(7):1065-87. doi: 10.2741/4268.
PubMed 24896337Stupp R, Hegi ME, Mason WP, van den Bent MJ, Taphoorn MJ, Janzer RC, Ludwin SK, Allgeier A, Fisher B, Belanger K, Hau P, Brandes AA, Gijtenbeek J, Marosi C, Vecht CJ, Mokhtari K, Wesseling P, Villa S, Eisenhauer E, Gorlia T, Weller M, Lacombe D, Cairncross JG, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumour and Radiation Oncology Groups; National Cancer Institute of Canada Clinical Trials Group. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol. 2009 May;10(5):459-66. doi: 10.1016/S1470-2045(09)70025-7. Epub 2009 Mar 9.
PubMed 19269895Bloch O, Han SJ, Cha S, Sun MZ, Aghi MK, McDermott MW, Berger MS, Parsa AT. Impact of extent of resection for recurrent glioblastoma on overall survival: clinical article. J Neurosurg. 2012 Dec;117(6):1032-8. doi: 10.3171/2012.9.JNS12504. Epub 2012 Oct 5.
PubMed 23039151Claus EB, Walsh KM, Wiencke JK, Molinaro AM, Wiemels JL, Schildkraut JM, Bondy ML, Berger M, Jenkins R, Wrensch M. Survival and low-grade glioma: the emergence of genetic information. Neurosurg Focus. 2015 Jan;38(1):E6. doi: 10.3171/2014.10.FOCUS12367.
PubMed 25552286Li YM, Suki D, Hess K, Sawaya R. The influence of maximum safe resection of glioblastoma on survival in 1229 patients: Can we do better than gross-total resection? J Neurosurg. 2016 Apr;124(4):977-88. doi: 10.3171/2015.5.JNS142087. Epub 2015 Oct 23.
PubMed 26495941Sanai N, Berger MS. Glioma extent of resection and its impact on patient outcome. Neurosurgery. 2008 Apr;62(4):753-64; discussion 264-6. doi: 10.1227/01.neu.0000318159.21731.cf.
PubMed 18496181Hervey-Jumper SL, Berger MS. Role of surgical resection in low- and high-grade gliomas. Curr Treat Options Neurol. 2014 Apr;16(4):284. doi: 10.1007/s11940-014-0284-7.
PubMed 24595756Beiko J, Suki D, Hess KR, Fox BD, Cheung V, Cabral M, Shonka N, Gilbert MR, Sawaya R, Prabhu SS, Weinberg J, Lang FF, Aldape KD, Sulman EP, Rao G, McCutcheon IE, Cahill DP. IDH1 mutant malignant astrocytomas are more amenable to surgical resection and have a survival benefit associated with maximal surgical resection. Neuro Oncol. 2014 Jan;16(1):81-91. doi: 10.1093/neuonc/not159. Epub 2013 Dec 4.
PubMed 24305719Cohen AL, Holmen SL, Colman H. IDH1 and IDH2 mutations in gliomas. Curr Neurol Neurosci Rep. 2013 May;13(5):345. doi: 10.1007/s11910-013-0345-4.
PubMed 23532369Noushmehr H, Weisenberger DJ, Diefes K, Phillips HS, Pujara K, Berman BP, Pan F, Pelloski CE, Sulman EP, Bhat KP, Verhaak RG, Hoadley KA, Hayes DN, Perou CM, Schmidt HK, Ding L, Wilson RK, Van Den Berg D, Shen H, Bengtsson H, Neuvial P, Cope LM, Buckley J, Herman JG, Baylin SB, Laird PW, Aldape K; Cancer Genome Atlas Research Network. Identification of a CpG island methylator phenotype that defines a distinct subgroup of glioma. Cancer Cell. 2010 May 18;17(5):510-22. doi: 10.1016/j.ccr.2010.03.017. Epub 2010 Apr 15.
PubMed 20399149Kickingereder P, Sahm F, Radbruch A, Wick W, Heiland S, Deimling Av, Bendszus M, Wiestler B. IDH mutation status is associated with a distinct hypoxia/angiogenesis transcriptome signature which is non-invasively predictable with rCBV imaging in human glioma. Sci Rep. 2015 Nov 5;5:16238. doi: 10.1038/srep16238.
PubMed 26538165
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety and Feasibility of Preoperative and Intraoperative Image-Guided Resection of Gliomas and Tumor Region-Specific Biomarker Correlation
- ClinicalTrials.gov ID
- NCT03542409
- Acronym / sponsor ID
- 77238
- Conditions
- Brain Tumor Adult
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 28 Oct 2021 (actual)
- Study completion
- 14 May 2025 (actual)
- First posted
- 31 May 2018 (actual)
- 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 evaluates the use of specialized magnetic resonance imaging (MRI) techniques including magnetic resonance (MR) perfusion and 2-hydroxyglutarate (2HG) spectroscopy in the surgical treatment of gliomas.
Cohort 1 participants will undergo an MR perfusion scan or 2-HG spectroscopy prior to surgery and intra-operatively.
Cohort 2 participants will only undergo standard of care imaging and tumor acquisition. Participant participation will end at the completion of surgery and will be transitioned to standard of care follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1, Group A (contrast enhancing tumor) | Experimental | Device: MR Perfusion ScanGroup A patients will undergo standard tumor preoperative imaging and MR perfusion scan prior to surgical resection. Group A patients will undergo standard intraoperative imaging along with MR perfusion scan during surgical resection. |
| Cohort 1, Group B (non-enhancing tumor) | Experimental | Device: 2HG Spectroscopy ScanGroup B patients will undergo standard tumor preoperative imaging and 2HG spectroscopy scan prior to surgical resection. Group A patients will undergo standard intraoperative imaging along with 2HG spectroscopy scan during surgical resection. |
| Cohort 2 | Experimental | Device: Standard of Care Intraoperative MRIDuring the analysis for cohort 1, we found significant differences in the pre MRI samples and the post intraoperative MRI samples. Cohort 2, which will include 10 additional patients, has be created to confirm these differences. Unlike cohort 1, advanced imaging (2-HG spectroscopy and MR perfusion) is not needed to make this comparison. The standard of care intraoperative MRI sequences used routinely will be sufficient for these 10 new samples. The specific aim of Cohort 2 is: 1. Compare areas from initial surgery with that of extended resection after intraoperative SOC MRI in 10 additional subjects (Cohort 2). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years
- Suspected glioma (grade II, III, or IV)
- Preoperative MR perfusion (enhancing tumors)
- Preoperative MR 2-HG spectroscopy (nonenhancing tumors)
- Patient indicated for surgical resection, standard radiation, and standard chemotherapy as a standard of care
Key exclusion criteria (9 listed)
- Prior diagnosis of intracranial glioma
- Other malignancy with expected need for systemic therapy within 3 years
- Inability to have 6000 grays of radiation to the brain
- Need for urgent palliative intervention for primary disease (e.g., impending herniation)
- Evidence of bleeding diathesis or coagulopathy
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 |
|---|---|---|
| MR Perfusion ScanMR perfusion scan before and during surgery. | Device | Cohort 1, Group A (contrast enhancing tumor) |
| 2HG Spectroscopy Scan2HG spectroscopy scan before and during surgery. | Device | Cohort 1, Group B (non-enhancing tumor) |
| Standard of Care Intraoperative MRIThe standard of care intraoperative MRI sequences used routinely will be sufficient for these 10 new samples. | Device | Cohort 2 |
Primary outcome
Intraoperative Imaging Completion
Time frame: 1 day
This is a feasibility study to see whether advanced imaging modalities can be used intraoperatively so the primary outcome is a yes/no regarding completion of imaging.
Incidence of Patient Complications Following Tumor Resection
Time frame: 1 year
Any surgical complications at post-op, hospital discharge, 1-month, 3-months, 6-months, and 1 year following surgery using the Common Terminology Criteria for Adverse Events (CTCAE)
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 10 Aug 2026.
- Background: PubMed 24305704Jensen RL, Mumert ML, Gillespie DL, Kinney AY, Schabel MC, Salzman KL. Preoperative dynamic contrast-enhanced MRI correlates with molecular markers of hypoxia and vascularity in specific areas of intratumoral microenvironment and is predictive of patient outcome. Neuro Oncol. 2014 Jan;16(2):280-91. doi: 10.1093/neuonc/not148. Epub 2013 Dec 4.
- Background: PubMed 25727224Chen R, Ravindra VM, Cohen AL, Jensen RL, Salzman KL, Prescot AP, Colman H. Molecular features assisting in diagnosis, surgery, and treatment decision making in low-grade gliomas. Neurosurg Focus. 2015 Mar;38(3):E2. doi: 10.3171/2015.1.FOCUS14745.
- Background: PubMed 25727226Karsy M, Neil JA, Guan J, Mahan MA, Colman H, Jensen RL. A practical review of prognostic correlations of molecular biomarkers in glioblastoma. Neurosurg Focus. 2015 Mar;38(3):E4. doi: 10.3171/2015.1.FOCUS14755.
- Background: PubMed 20414201Huse JT, Holland EC. Targeting brain cancer: advances in the molecular pathology of malignant glioma and medulloblastoma. Nat Rev Cancer. 2010 May;10(5):319-31. doi: 10.1038/nrc2818.
- Background: PubMed 24896337Karsy M, Huang T, Kleinman G, Karpel-Massler G. Molecular, histopathological, and genomic variants of glioblastoma. Front Biosci (Landmark Ed). 2014 Jun 1;19(7):1065-87. doi: 10.2741/4268.
- Background: PubMed 19269895Stupp R, Hegi ME, Mason WP, van den Bent MJ, Taphoorn MJ, Janzer RC, Ludwin SK, Allgeier A, Fisher B, Belanger K, Hau P, Brandes AA, Gijtenbeek J, Marosi C, Vecht CJ, Mokhtari K, Wesseling P, Villa S, Eisenhauer E, Gorlia T, Weller M, Lacombe D, Cairncross JG, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumour and Radiation Oncology Groups; National Cancer Institute of Canada Clinical Trials Group. Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial. Lancet Oncol. 2009 May;10(5):459-66. doi: 10.1016/S1470-2045(09)70025-7. Epub 2009 Mar 9.
- Background: PubMed 23039151Bloch O, Han SJ, Cha S, Sun MZ, Aghi MK, McDermott MW, Berger MS, Parsa AT. Impact of extent of resection for recurrent glioblastoma on overall survival: clinical article. J Neurosurg. 2012 Dec;117(6):1032-8. doi: 10.3171/2012.9.JNS12504. Epub 2012 Oct 5.
- Background: PubMed 25552286Claus EB, Walsh KM, Wiencke JK, Molinaro AM, Wiemels JL, Schildkraut JM, Bondy ML, Berger M, Jenkins R, Wrensch M. Survival and low-grade glioma: the emergence of genetic information. Neurosurg Focus. 2015 Jan;38(1):E6. doi: 10.3171/2014.10.FOCUS12367.
- Background: PubMed 26495941Li YM, Suki D, Hess K, Sawaya R. The influence of maximum safe resection of glioblastoma on survival in 1229 patients: Can we do better than gross-total resection? J Neurosurg. 2016 Apr;124(4):977-88. doi: 10.3171/2015.5.JNS142087. Epub 2015 Oct 23.
- Background: PubMed 18496181Sanai N, Berger MS. Glioma extent of resection and its impact on patient outcome. Neurosurgery. 2008 Apr;62(4):753-64; discussion 264-6. doi: 10.1227/01.neu.0000318159.21731.cf.
- Background: PubMed 24595756Hervey-Jumper SL, Berger MS. Role of surgical resection in low- and high-grade gliomas. Curr Treat Options Neurol. 2014 Apr;16(4):284. doi: 10.1007/s11940-014-0284-7.
- Background: PubMed 24305719Beiko J, Suki D, Hess KR, Fox BD, Cheung V, Cabral M, Shonka N, Gilbert MR, Sawaya R, Prabhu SS, Weinberg J, Lang FF, Aldape KD, Sulman EP, Rao G, McCutcheon IE, Cahill DP. IDH1 mutant malignant astrocytomas are more amenable to surgical resection and have a survival benefit associated with maximal surgical resection. Neuro Oncol. 2014 Jan;16(1):81-91. doi: 10.1093/neuonc/not159. Epub 2013 Dec 4.
- 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.
Randy Jensen, MD, PhD principal investigator
Huntsman Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing MR Perfusion Scan and 2HG Spectroscopy Scan in people with Brain Tumor Adult, run by University of Utah 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 9 inclusion and 9 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 10 Aug 2026. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Intraoperative Imaging Completion (time frame: 1 day). The study lists 2 primary outcomes in all. 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 NCT03542409, which also lists 42 linked publications.
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 10 Aug 2026.