AzTrials
AzTrials

Adult Anaplastic AstrocytomaEarly Phase 1NCT01996527

3T MRI Biomarkers of Glioma Treatment Response

A Early Phase 1 study testing 3-Tesla magnetic resonance imaging, CEST-MRI and DW-MRI in people with Adult Anaplastic Astrocytoma and Adult Anaplastic Ependymoma, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This pilot clinical trial studies advanced magnetic resonance imaging (MRI) techniques in measuring treatment response in patients with high-grade glioma. New diagnostic procedures, such as advanced MRI techniques at 3 Tesla, may be more effective than standard MRI in measuring treatment response in patients receiving… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
3-Tesla magnetic resonance imaging, CEST-MRI and DW-MRI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteUnited States
Study dates
May 2012to 1 Jan 2016
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

  • Patients must sign an institutional review board (IRB)-approved informed consent document
  • Patients must have been diagnosed with high-grade glioma:
  • World Health Organization (WHO) grade III: anaplastic astrocytoma, oligodendroglioma, ependymoma, or oligoastrocytoma; OR
  • WHO grade IV: glioblastoma multiforme; or neuroepithelial tumors of uncertain origin (polar spongioblastoma, astroblastoma, or gliomatosis cerebri)
  • As measured by conventional high spatial resolution MRI, the minimum diameter of the primary lesion (short axis) should be at least 5 mm
  • Patients must be scheduled to receive: 1) standard chemotherapy with/without radiation therapy; OR 2) single-agent bevacizumab (Avastin)

Who cannot join

  • Patients with low-grade (WHO grade I or II) glioma
  • Patients with metastatic disease
  • Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc), because such devices may be displaced or malfunction
  • Patients who have any type of ferromagnetic bioimplant that could potentially be displaced
  • Patients who have cerebral aneurysm clips
  • Patients who may have shrapnel imbedded in their bodies (such as from war wounds), metal workers and machinists (potential for metallic fragments in or near the eyes)
Show all 16Show fewer
  • Patients with inadequate renal function (creatinine >= 1.5 times upper limit of normal) or acute or chronic renal insufficiency (glomerular filtration rate < 20 ml/min)
  • Patients who are pregnant or breast feeding; urine pregnancy test will be performed on women of child bearing potential
  • Patients who exhibit noticeable anxiety and/or claustrophobia or who exhibit severe vertigo when they are moved into the magnet bore
  • Patients incapable of giving informed written consent, for the following reasons:
  • Inability to adhere to the experimental protocols for any reason
  • Inability to communicate with the research team
  • Limited ability to give informed consent due to mental disability, altered mental status, confusion, cognitive impairment, or psychiatric disorders
  • Patients scoring 14.5 or lower on the University of California at San Diego (UCSD) Brief Assessment of Consent Capacity (UBACC) Capacity to Consent Questionnaire will be excluded
  • Prisoners or other individuals deemed to be susceptible to coercion
  • For patients who have undergone surgical resection prior to joining the study, in whom baseline magnetic resonance (MR) images exhibit enough signal degradation (due to susceptibility artifact in the region of the surgical bed) such that the data are uninterpretable will be excluded

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

Other trials in United States

About this study

Official title: Early Detection of Glioma Treatment Response Using MRI-Based Biomarkers

This pilot clinical trial studies advanced magnetic resonance imaging (MRI) techniques in measuring treatment response in patients with high-grade glioma. New diagnostic procedures, such as advanced MRI techniques at 3 Tesla, may be more effective than standard MRI in measuring treatment response in patients receiving treatment for high-grade gliomas.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To correlate treatment-induced changes in quantitative MRI-based biomarkers-specifically, those sensitive to tumor protein content (amide proton transfer asymmetry [APTasym] from chemical exchange saturation transfer [CEST]), cellularity (apparent diffusion coefficient [ADC] from diffusion-weighted imaging [DWI]), and blood flow (volume transfer constant [K^trans] from dynamic contrast-enhanced [DCE]; cerebral blood flow [CBF] from dynamic susceptibility contrast [DSC])-with treatment-induced changes in tumor size, measured via standard anatomic MRI.

II. To correlate treatment-induced changes in the above quantitative MRI endpoints with patient progression-free survival (PFS).

OUTLINE:

Patients undergo measurement of tumor protein content using CEST-MRI, cellularity using DWI-MRI, and blood flow using DCE-MRI and DSC-MRI within 2 weeks of treatment and at 2 and 4 weeks after initiation of treatment.

Being tested
3-Tesla magnetic resonance imaging, CEST-MRI, DW-MRI, DCE-MRI, DSC-MRI
Medical subject headings
Astrocytoma, Ependymoma, Oligodendroglioma, Glioblastoma, Gliosarcoma, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3-Tesla magnetic resonance imagingDevice

    Also called 3-Tesla MRI, 3T MRI

    3-Tesla MRI is a multiparametric imaging exam that includes MR pulse sequences for CEST-MRI, DW-MRI, DCE-MRI, and DSC-MRI

  • CEST-MRIDevice

    Also called chemical exchange saturation transfer MRI

    Undergo CEST-MRI

  • DW-MRIDevice

    Also called diffusion-weighted MRI

    Undergo DWI-MRI

  • DCE-MRIDevice

    Also called dynamic contrast-enhanced MRI

    Undergo DCE-MRI

  • DSC-MRIDevice

    Also called dynamic susceptibility contrast MRI

    Undergo DSC-MRI

  • IV administration of gadolinium-containing contrast agentDrug

    Also called Magnevist®, gadopentetate dimeglumine

    Gadolinium-containing paramagnetic contrast agent (Magnevist®; Berlex Lab, Wayne, New Jersey) in delivered via intravenous (IV) infusion to achieve DCE and DSC contrast

Study groups in NCT01996527
Study groupRoleWhat they receive
3-Tesla magnetic resonance imagingExperimentalPatients undergo 3-Tesla magnetic resonance imaging to measure tumor protein content (using CEST-MRI), cellularity (using DW-MRI), and blood flow (using DCE-MRI and DSC-MRI with IV administration of gadolinium-containing contrast agent) no more than 2 weeks before, and 2 and 4 weeks after, the initiation of treatment.
Receives: Device: 3-Tesla magnetic resonance imaging; Device: CEST-MRI; Device: DW-MRI; Device: DCE-MRI; Device: DSC-MRI; Drug: IV administration of gadolinium-containing contrast agent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Best Response

    Number of patients in each response category, per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, summarized as follows for target lesion criteria: complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD.

    Measured: On-treatment date to date of disease progression (up to 12 weeks)

Secondary outcomes (1)

  1. Progression Free Survival (PFS)

    Estimated probable duration of life without disease progression, from on-study date to earlier of progression date or date of death from any cause, using the Kaplan-Meier method with censoring. Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters (LD) of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions.

    Measured: On-study date to lesser of date of progression or date of death from any cause (assessed at 6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2013 (estimated)
  2. Study startMay 2012
  3. Primary completion23 Nov 2015
  4. Study completion1 Jan 2016

Why it stopped: PI left institution

Resources

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
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01996527
Sponsor's protocol ID
VICC NEU 1268
Other IDs
NCI-2013-02195, P30CA068485
Status last verified
Apr 2017
First submitted
15 Nov 2013
Last updated
17 Apr 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing 3-Tesla magnetic resonance imaging, CEST-MRI and DW-MRI in people with Adult Anaplastic Astrocytoma and Adult Anaplastic Ependymoma, run by Vanderbilt-Ingram Cancer Center 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 6 inclusion and 16 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: stopped early, as of the sponsor's last update on 17 Apr 2017. 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 stopped early (reason given: PI left institution). Results are not available in the source record.

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?

Best Response (time frame: On-treatment date to date of disease progression (up to 12 weeks)). 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 NCT01996527.

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 17 Apr 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in