Glioblastoma MultiformeEarly Phase 1NCT04776980
Multimodality MRI and Liquid Biopsy in GBM
A Early Phase 1 study testing Post Feraheme Infusion MRI in people with Glioblastoma Multiforme and Brain Tumor, Adult: Glioblastoma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
Patients with a new diagnosis of high-grade glioma based on MRI, who are considered surgical candidates determined by neurosurgeons or patients with recurrent glioblastoma with the initial diagnosis of glioblastoma (histologic or molecular proof) and recommended for clinically surgical resection may be eligible for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme, Brain Tumor, Adult: Glioblastoma, Brain Tumor, Recurrent
- What is being tested?
- Post Feraheme Infusion MRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2022to 22 Jun 2022
- 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
- Participants will be ≥ 18 years of age
- Patients with new diagnosis of high grade glioma based on MRI, who are considered surgical candidates determined by neurosurgeons or recurrent glioblastoma with the initial diagnosis of glioblastoma (histologic or molecular proof) and recommended for clinically surgical resection
- Life expectancy of greater than 3 months in the opinion of an investigator or treating physician.
- Karnofsky performance status ≥ 60
Who cannot join
- Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
- Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; pregnancy status will be confirmed verbally prior to participating in any study procedures.
- Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
- Contraindications to MRI or use of ferumoxytol or gadolinium contrast
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Multimodality MRI for Quantification of Tumor-associated Macrophages and Prediction of Somatic Mutation Detectability in Cell-free DNA in Adult Patients With Glioblastoma
Patients with a new diagnosis of high-grade glioma based on MRI, who are considered surgical candidates determined by neurosurgeons or patients with recurrent glioblastoma with the initial diagnosis of glioblastoma (histologic or molecular proof) and recommended for clinically surgical resection may be eligible for this study. Subjects may participate in this study if they are at least 18 years of age.
Ferumoxytol-enhanced MRI will be used to quantify tumor-associated macrophages. This is a non-therapeutic trial in that imaging will not be used to direct treatment decisions.
The blood draw is being completed to evaluate cell-free circulating tumor DNA (cfDNA) and cell-free tumor DNA (ctDNA).
Read the detailed description
This is a pilot study in subjects with a new diagnosis of high-grade glioma based on classic MRI appearance who are considered surgical candidates and patients with histologically proven diagnosis of glioblastoma (GB) who have completed chemoradiation and now have new contrast-enhancing lesions or lesions showing increased enhancement ( 25% increase) who are recommended for a clinical surgical resection. Subjects may participate in this study if they are at least 18 years of age, most participants will be receiving care at the clinical practices of the University of Pennsylvania. Subjects who come to the University of Pennsylvania for diagnosis and/or treatment of GB and who meet the study inclusion criteria may be approached by study personnel for recruitment into this study. Subjects will be approached about study participation regardless of race or ethnic background. Investigators anticipate enrolling up to 30 participants. Subjects who consent but do not complete the study imaging will be considered not evaluable and will be replaced. Accrual will likely occur over approximately 2 years. After undergoing screening assessments and verifying eligibility for study participation subjects will undergo a research ferumoxytol-enhanced MRI of the brain and blood draws for liquid biopsy.
- Conditions
- Glioblastoma Multiforme, Brain Tumor, Adult: Glioblastoma, Brain Tumor, Recurrent, Brain Tumor, Primary
- Being tested
- Post Feraheme Infusion MRI
- Medical subject headings
- Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post Feraheme Infusion MRIDiagnostic test
All participants will receive a ferumoxtyol (Feraheme) infusion 20-28 hours prior to a head MRI. In addition, a blood draw for liquid biopsy targeted tissue sampling during surgery and special iron and macrophage staining on the tumor tissue.
| Study group | Role | What they receive |
|---|---|---|
| Ferumoxytol Infused MRI | Experimental | Ferumoxytol is an iron replacement product that is FDA approved to treat iron deficiency anemia in patients with chronic kidney disease (CKD). In this study, ferumoxytol is used to quantify tumor-associated macrophages. The infused dose would be 5mg/kg. Receives: Diagnostic Test: Post Feraheme Infusion MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macrophage quantification status
Macrophage quantification status will be determined using histology methods based on biopsy sites and will be correlated with ferumoxytol-enhanced MRI.
Measured: 2 years
Secondary outcomes (1)
Cell free tumor DNA (ctDNA)
To determine the proportion of mutations identified by biopsy that are correctly identified in samples of plasma ctDNA for each subject, and to explore the potential of imaging measures to predict that proportion
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study startJun 2022 (estimated)
- Primary completionJun 2022 (estimated)
- Study completion22 Jun 2022 (estimated)
Why it stopped: PI decision to close study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Nabavizadeh, Abramson Cancer Center at Penn Medicine
- Investigators
- Seyed Ali Nabavizadeh, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776980
- Sponsor's protocol ID
- 843601
- Status last verified
- Sep 2022
- First submitted
- 25 Feb 2021
- Last updated
- 16 Sep 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodality MRI for Quantification of Tumor-associated Macrophages and Prediction of Somatic Mutation Detectability in Cell-free DNA in Adult Patients With Glioblastoma
- ClinicalTrials.gov ID
- NCT04776980
- Acronym / sponsor ID
- 843601
- Conditions
- Glioblastoma Multiforme, Brain Tumor, Adult: Glioblastoma, Brain Tumor, Recurrent, Brain Tumor, Primary
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI decision to close study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- 22 Jun 2022 (estimated)
- First posted
- 2 Mar 2021 (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.
Patients with a new diagnosis of high-grade glioma based on MRI, who are considered surgical candidates determined by neurosurgeons or patients with recurrent glioblastoma with the initial diagnosis of glioblastoma (histologic or molecular proof) and recommended for clinically surgical resection may be eligible for this study. Subjects may participate in this study if they are at least 18 years of age.
Ferumoxytol-enhanced MRI will be used to quantify tumor-associated macrophages. This is a non-therapeutic trial in that imaging will not be used to direct treatment decisions.
The blood draw is being completed to evaluate cell-free circulating tumor DNA (cfDNA) and cell-free tumor DNA (ctDNA).
Detailed description
This is a pilot study in subjects with a new diagnosis of high-grade glioma based on classic MRI appearance who are considered surgical candidates and patients with histologically proven diagnosis of glioblastoma (GB) who have completed chemoradiation and now have new contrast-enhancing lesions or lesions showing increased enhancement ( 25% increase) who are recommended for a clinical surgical resection. Subjects may participate in this study if they are at least 18 years of age, most participants will be receiving care at the clinical practices of the University of Pennsylvania. Subjects who come to the University of Pennsylvania for diagnosis and/or treatment of GB and who meet the study inclusion criteria may be approached by study personnel for recruitment into this study. Subjects will be approached about study participation regardless of race or ethnic background. Investigators anticipate enrolling up to 30 participants. Subjects who consent but do not complete the study imaging will be considered not evaluable and will be replaced. Accrual will likely occur over approximately 2 years. After undergoing screening assessments and verifying eligibility for study participation subjects will undergo a research ferumoxytol-enhanced MRI of the brain and blood draws for liquid biopsy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ferumoxytol Infused MRI | Experimental | Diagnostic Test: Post Feraheme Infusion MRIFerumoxytol is an iron replacement product that is FDA approved to treat iron deficiency anemia in patients with chronic kidney disease (CKD). In this study, ferumoxytol is used to quantify tumor-associated macrophages. The infused dose would be 5mg/kg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants will be ≥ 18 years of age
- Patients with new diagnosis of high grade glioma based on MRI, who are considered surgical candidates determined by neurosurgeons or recurrent glioblastoma with the initial diagnosis of glioblastoma (histologic or molecular proof) and recommended for clinically surgical resection
- Life expectancy of greater than 3 months in the opinion of an investigator or treating physician.
- Karnofsky performance status ≥ 60
Key exclusion criteria (4 listed)
- Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
- Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; pregnancy status will be confirmed verbally prior to participating in any study procedures.
- Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study
- Contraindications to MRI or use of ferumoxytol or gadolinium contrast
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 |
|---|---|---|
| Post Feraheme Infusion MRIAll participants will receive a ferumoxtyol (Feraheme) infusion 20-28 hours prior to a head MRI. In addition, a blood draw for liquid biopsy targeted tissue sampling during surgery and special iron and macrophage staining on the tumor tissue. | Diagnostic test | Ferumoxytol Infused MRI |
Primary outcome
Macrophage quantification status
Time frame: 2 years
Macrophage quantification status will be determined using histology methods based on biopsy sites and will be correlated with ferumoxytol-enhanced MRI.
1 secondary outcome
Cell free tumor DNA (ctDNA)
Time frame: 2 years
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 16 Sep 2022.
- 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.
Seyed Ali Nabavizadeh, MD principal investigator
University of Pennsylvania
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 Post Feraheme Infusion MRI in people with Glioblastoma Multiforme and Brain Tumor, Adult: Glioblastoma, run by Abramson Cancer Center at Penn Medicine 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 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: withdrawn, as of the sponsor's last update on 16 Sep 2022. 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 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?
Macrophage quantification status (time frame: 2 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 16 Sep 2022.