GliomaNCT03168919
Image-Based Quantitative Assessment of Acute Radiation-Induced Changes in Glioma
A study testing Fractionated Radiation, Temozolomide and MRI in people with Glioma, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The overall goal of this study is to determine if quantitative imaging techniques can be used to detect dynamic changes of morphology and different physiologic properties of the tumor during and after completion of radiation treatment and to predict site and time of radiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- Fractionated Radiation, Temozolomide and MRI
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2016to 12 Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Newly diagnosed glioma, based on pathology confirmation;
- At least 8 cm3 of residual enhancing tumor after surgery or significant visible tumor (As seen on immediate postoperative scan);
- Scheduled to receive standard fractionated RT with concomitant temozolomide therapy;
- Karnofsky Performance Score > 60.
Who cannot join
- Scheduled to receive investigational chemotherapy, immunotherapy, or any other investigational agents;
- Placement of GLIADEL® wafer in the resection cavity;
- Significant amount of hemorrhage within the resection cavity (seen on immediate post-operative scan);
- A large peritumoral infraction related to surgery (identified by new confluent diffusion restriction);
- Not suitable to undergo MRI or use the MRI contrast agent (GFR<30 mL/min/1.73 m2); or the patient has known anaphylactic reaction to gadolinium based contrast agents.
- Presence of serious systemic illness, including: uncontrolled infection, uncontrolled malignancy, significant renal disease, or psychiatric/social situations, which might impact the survival endpoint of the study or limit compliance with study requirements.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35249
About this study
The overall goal of this study is to determine if quantitative imaging techniques can be used to detect dynamic changes of morphology and different physiologic properties of the tumor during and after completion of radiation treatment and to predict site and time of radiation.
Read the detailed description
Once eligibility criteria have been assessed and the informed consent is obtained, participants will undergo a screening process to further ensure eligibility. Screening prior to registration will comprise a review of pathology reports, postoperative magnetic resonance Imaging (MRI) images, operative reports, and medical history; general physical and neurologic exams; routine blood work; and urine pregnancy test for women of childbearing age.
The study is intended to evaluate the response of radiation treatment (RT). The consent process will be performed between the surgery and the start of RT. RT will be prescribed as per the discretion of the treating radiation oncologist as per the University of Alabama at Birmingham Department of Radiation Oncology treatment protocol in combination with temozolomide.
MRIs will be obtained before start of RT, after completion of 20 +/- 4 Gy. after completion of 40+/- 4 Gy and after the entire radiation treatment. Conventional MRIs including perfusion sequences and whole brain spectroscopy will be performed as a part of the research study. The data obtained from this research studies will not be used for clinical management.
Volumes of the enhancing component, non enhancing component, choline/N-acetyl aspartate (Cho/NAA) will be measure before, during and after RT as described before. Cerebral blood volume (CBV) of the tumor will also be calculated from perfusion imaging at each time point. Apparent diffusion co-efficient (ADC) of the tumor will be calculated from the diffusion imaging.
All the patients will be followed up with imaging and will be treated as per the standard of care. Patients will return for clinical evaluation and standard of care imaging approximately 4 weeks from the completion of the radiation therapy. After that, all the patients will be treated with standard of care maintenance temozolomide therapy and will return every 2-3 months for clinical evaluation and standard of care imaging.
At the time of recurrence, the recurrence site will be assessed and will be compared with the imaging parameters obtained during radiation treatment. Time to recurrence will also be calculated and will be correlated with the imaging parameters.
- Conditions
- Glioma
- Being tested
- Fractionated Radiation, Temozolomide, MRI
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractionated RadiationRadiation
Standard of care fractionated radiation therapy will be given to the tumor.
TemozolomideDrug
Also called Temodar
Standard of care temozolomide will be given along with radiation therapy
MRIDevice
Also called Multi parametric MRI including MR spectroscopy
Four MRI scan will be performed according to the protocol. The first one will be obtained before start of radiation therapy, the second MRI will be obtained after completion of 20 +/- 4 Gy, the third MRI will be obtained after completion of 40 +/- 4 Gy, and the final MRI will be obtained after completion of the radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| Chemoradiation with MRI assessment | Experimental | This study has only one arm. The eligible subjects will receive standard of care fractionated radiation therapy along with concomitant temozolomide, which will NOT be changed based on the MRI scans obtained as a part of this study. There is no control or sham group. Receives: Radiation: Fractionated Radiation; Drug: Temozolomide; Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With the Changes of the Chemical Environment of the Tumor
Multiple MRI techniques will be used to assess chemical environment (Cho/NAA) of the tumor during the course of fractionated radiation treatment.
Measured: From Baseline to 6 weeks.
Secondary outcomes (3)
Changes of Tumor Cellularity
Diffusion MRI will be used for assessment of measures tumor cellularity (with minimum apparent diffusion co-efficent, ADC) during the course of fractionated radiation treatment.
Measured: From baseline to 6 weeks
Changes of Tumor Volume
MRI will be used for assessment of measures tumor volume.
Measured: From baseline Up to 6 weeks
Changes of Tumor Angiogenesis
Perfusion MRI will be used for assessment of tumor angiogenesis (with median normalized cerbral blood volume, nCBV) during the course of fractionated radiation treatment.
Measured: From baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start6 Oct 2016
- Primary completion12 Jun 2018
- Study completion12 Jun 2018
Why it stopped: PI is leaving institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One arm study
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asim Bag, University of Alabama at Birmingham
- Investigators
- Asim Bag, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03168919
- Sponsor's protocol ID
- F160324004
- Status last verified
- Sep 2019
- First submitted
- 28 Apr 2017
- Last updated
- 1 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image-Based Quantitative Assessment of Acute Radiation-Induced Changes in Glioma
- ClinicalTrials.gov ID
- NCT03168919
- Acronym / sponsor ID
- F160324004
- Conditions
- Glioma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI is leaving institution
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 6 Oct 2016 (actual)
- Primary completion
- 12 Jun 2018 (actual)
- Study completion
- 12 Jun 2018 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Posted 2 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this study is to determine if quantitative imaging techniques can be used to detect dynamic changes of morphology and different physiologic properties of the tumor during and after completion of radiation treatment and to predict site and time of radiation.
Detailed description
Once eligibility criteria have been assessed and the informed consent is obtained, participants will undergo a screening process to further ensure eligibility. Screening prior to registration will comprise a review of pathology reports, postoperative magnetic resonance Imaging (MRI) images, operative reports, and medical history; general physical and neurologic exams; routine blood work; and urine pregnancy test for women of childbearing age.
The study is intended to evaluate the response of radiation treatment (RT). The consent process will be performed between the surgery and the start of RT. RT will be prescribed as per the discretion of the treating radiation oncologist as per the University of Alabama at Birmingham Department of Radiation Oncology treatment protocol in combination with temozolomide.
MRIs will be obtained before start of RT, after completion of 20 +/- 4 Gy. after completion of 40+/- 4 Gy and after the entire radiation treatment. Conventional MRIs including perfusion sequences and whole brain spectroscopy will be performed as a part of the research study. The data obtained from this research studies will not be used for clinical management.
Volumes of the enhancing component, non enhancing component, choline/N-acetyl aspartate (Cho/NAA) will be measure before, during and after RT as described before. Cerebral blood volume (CBV) of the tumor will also be calculated from perfusion imaging at each time point. Apparent diffusion co-efficient (ADC) of the tumor will be calculated from the diffusion imaging.
All the patients will be followed up with imaging and will be treated as per the standard of care. Patients will return for clinical evaluation and standard of care imaging approximately 4 weeks from the completion of the radiation therapy. After that, all the patients will be treated with standard of care maintenance temozolomide therapy and will return every 2-3 months for clinical evaluation and standard of care imaging.
At the time of recurrence, the recurrence site will be assessed and will be compared with the imaging parameters obtained during radiation treatment. Time to recurrence will also be calculated and will be correlated with the imaging parameters.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One arm study
| Arm | Type | Receives |
|---|---|---|
| Chemoradiation with MRI assessment | Experimental | Radiation: Fractionated Radiation, Drug: Temozolomide, Device: MRIThis study has only one arm. The eligible subjects will receive standard of care fractionated radiation therapy along with concomitant temozolomide, which will NOT be changed based on the MRI scans obtained as a part of this study. There is no control or sham group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Newly diagnosed glioma, based on pathology confirmation;
- At least 8 cm3 of residual enhancing tumor after surgery or significant visible tumor (As seen on immediate postoperative scan);
- Scheduled to receive standard fractionated RT with concomitant temozolomide therapy;
- Karnofsky Performance Score > 60.
Key exclusion criteria (6 listed)
- Scheduled to receive investigational chemotherapy, immunotherapy, or any other investigational agents;
- Placement of GLIADEL® wafer in the resection cavity;
- Significant amount of hemorrhage within the resection cavity (seen on immediate post-operative scan);
- A large peritumoral infraction related to surgery (identified by new confluent diffusion restriction);
- Not suitable to undergo MRI or use the MRI contrast agent (GFR<30 mL/min/1.73 m2); or the patient has known anaphylactic reaction to gadolinium based contrast agents.
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 |
|---|---|---|
| Fractionated RadiationStandard of care fractionated radiation therapy will be given to the tumor. | Radiation | Chemoradiation with MRI assessment |
| TemozolomideAlso: TemodarStandard of care temozolomide will be given along with radiation therapy | Drug | Chemoradiation with MRI assessment |
| MRIAlso: Multi parametric MRI including MR spectroscopyFour MRI scan will be performed according to the protocol. The first one will be obtained before start of radiation therapy, the second MRI will be obtained after completion of 20 +/- 4 Gy, the third MRI will be obtained after completion of 40 +/- 4 Gy, and the final MRI will be obtained after completion of the radiation therapy. | Device | Chemoradiation with MRI assessment |
Primary outcome
Number of Participants With the Changes of the Chemical Environment of the Tumor
Time frame: From Baseline to 6 weeks.
Multiple MRI techniques will be used to assess chemical environment (Cho/NAA) of the tumor during the course of fractionated radiation treatment.
3 secondary outcomes
Changes of Tumor Cellularity
Time frame: From baseline to 6 weeks
Changes of Tumor Volume
Time frame: From baseline Up to 6 weeks
Changes of Tumor Angiogenesis
Time frame: From baseline to 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Asim Bag, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractionated Radiation, Temozolomide and MRI in people with Glioma, run by University of Alabama at Birmingham 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 6 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 1 Oct 2019. 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?
Yes. Results are posted in the registry (first posted 2 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With the Changes of the Chemical Environment of the Tumor (time frame: From Baseline to 6 weeks.). 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 1 Oct 2019.