GlioblastomaRELAYNCT04188535
Serial MRI Scans During Radiation Therapy
A study testing MRI IMAGING in people with Glioblastoma and Esophageal Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
This is a phase 1 study to determine the feasibility and utility of using serial magnetic resonance imaging (MRI) to assess treatment response during and after radiation therapy (standard of care cancer treatment) for participants with advanced esophageal cancer, glioblastoma, prostate cancer, vulvar cancer or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma, Esophageal Cancer, Radiotherapy
- What is being tested?
- MRI IMAGING
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jan 2020to 31 Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 must have a confirmed malignancy requiring radiation therapy.
- Age: 18 years or older except where otherwise specified in subprotocol.
- ECOG performance status ≤2 (Karnofsky ≥60%)
- Ability to understand and the willingness to sign a written informed consent document.
- Any further criteria listed in the specific disease site subprotocol.
- (Esophageal cohort) Patients must be considered appropriate candidates for neoadjuvant chemoradiation therapy followed by esophagectomy. Patients must have an endoscopic ultrasound done or scheduled to be done at the baseline visit.
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- (Glioblastoma cohort) Patients with a histologically confirmed newly diagnosed intracranial glioblastoma or gliosarcoma who will be undergoing radiation therapy as part of clinical care.
- (Prostate cohort) Patients with localized prostate cancer who are planning to receive androgen deprivation therapy and definitive radiation therapy.
- (Vulvar cohort) Patients with biopsy-proven locally advanced vulvar cancer for which definitive radiotherapy is planned.
- (Pediatric glioma cohort) Patients age 18 or under (patients 18-30 years old are also eligible if the physician determines that based on genetics, the tumor biology is consistent with pediatric high grade glioma). Patients with a histologically confirmed newly diagnosed high-grade glioma (WHO grade III or IV) who will be undergoing radiation therapy as part of clinical care. Patients with DIPG are only eligible if biopsy-confirmed high grade DIPG is present. Ability to understand and/or willingness of their parent or legally authorized representative to sign a written informed consent document.
- (Sarcoma cohort) Patients with a histologically confirmed newly diagnosed high-grade glioma (WHO grade III or IV) who will be undergoing radiation therapy as part of clinical care.
Who cannot join
- Disease-specific exclusion criteria will be specified in a subprotocol.
- For MRI involving contrast, history of allergic reactions attributed to gadolinium-based IV contrast. If patient will not receive contrast, this is not applicable and kidney function will not affect eligibility.
- Inability to undergo magnetic resonance imaging (MRI).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Brigham and Women Hospital
Boston, Massachusetts, 02115
Jonathan Leeman, MD, JONATHANE_LEEMAN@DFCI.HARVARD.EDU
Jonathan Leeman, MD
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Jonathan Leeman, MD, (617) 732-6452, JONATHANE_LEEMAN@DFCI.HARVARD.EDU
Jonathan Leeman, MD
About this study
Official title: RELAY: Repeated Magnetic Resonance Imaging Examinations to Analyze and Assess Your Cancer: A Prospective Study on the Use of Serial Magnetic Resonance Imaging in the Assessment of Changes During Treatment With Radiation Therapy
This is a phase 1 study to determine the feasibility and utility of using serial magnetic resonance imaging (MRI) to assess treatment response during and after radiation therapy (standard of care cancer treatment) for participants with advanced esophageal cancer, glioblastoma, prostate cancer, vulvar cancer or pediatric glioma.
The research study procedures include three MRI scans (one before, one during, and one after standard of care cancer radiation therapy) for participants with advanced esophageal cancer, glioblastoma, prostate cancer, vulvar cancer or pediatric glioma.
The research study procedures include:
- Screening for eligibility
- Three MRI scans
Read the detailed description
This is a phase 1, non-randomized, open-label study evaluating feasibility of serial MRI, with an option for an expansion cohort. The optional expansion cohort is a prospective imaging registry evaluating imaging biomarkers as predictors of disease control with standard of care treatment.
This research study is a feasibility study, meaning that it is the first time that investigators at this institution are examining the process of getting multiple MRIs during radiation treatment.
The U.S. Food and Drug Administration (FDA) has cleared this MRI scanner for use.
Participants who fulfill eligibility criteria will be entered into the trial.
The research study procedures include screening for eligibility, and three MRI scans. MRI imaging will be performed as per disease site standards.
A total of 149 participants will be enrolled in this trial:
- 13 participants in the esophageal cancer cohort
- 10 participants in the initial glioblastoma cohort and 36 participants in the image registry expansion cohort
- 10 participants in the prostate cancer cohort and 50 participants in the image registry expansion cohort
- 10 participants in the vulvar cancer cohort
- 10 participants in the pediatric glioma cohort
- 10 participants in the sarcoma cohort
- Conditions
- Glioblastoma, Esophageal Cancer, Radiotherapy, Magnetic Resonance Imaging, MRI, Prostate Cancer
- Being tested
- MRI IMAGING
- Keywords
- Glioblastoma, Esophageal Cancer, Radiotherapy, Magnetic Resonance Imaging, MRI, Prostate Cancer, Vulvar Cancer, Pediatric Glioblastoma Multiforme, sarcoma
- Medical subject headings
- Glioblastoma, Esophageal Neoplasms, Prostatic Neoplasms, Vulvar Neoplasms, Astrocytoma, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI IMAGINGDiagnostic test
Imaging with MRI will be performed as per disease site standards.
| Study group | Role | What they receive |
|---|---|---|
| Esophageal Cohort | Experimental | The research study procedures include:
* Screening for eligibility
* Three MRI scans (prior to start of standard cancer treatment, in the middle, and at the end of radiation treatment). Imaging with MRI will be performed as per disease site standards. Receives: Diagnostic Test: MRI IMAGING |
| Glioblastoma Cohort | Experimental | The research study procedures include:
* Screening for eligibility
* Three MRI scans prior to start of standard cancer treatment, in the middle, and at the end of radiation treatment). Imaging with MRI will be performed as per disease site standards. Receives: Diagnostic Test: MRI IMAGING |
| Glioblastoma Expansion Cohort Serial MR Imaging Registry | Experimental | The research study procedures include:
* Screening for eligibility
* Three MRI scans prior to start of standard cancer treatment, in the middle, and at the end of radiation treatment). Imaging with MRI will be performed as per disease site standards. Receives: Diagnostic Test: MRI IMAGING |
| Prostate Cancer Cohort | Experimental | The research study procedures include:
* Screening for eligibility
* Three MRI scans prior to start of androgen deprivation therapy, prior to the start of radiation treatment, and after radiation treatment). Imaging with MRI will be performed as per disease site standards.
* Genomic testing of biopsy sample Receives: Diagnostic Test: MRI IMAGING |
| Prostate Cancer Expansion Cohort Serial MR Imaging Registry | Experimental | The research study procedures include:
* Screening for eligibility
* Three MRI scans prior to start of androgen deprivation therapy, prior to the start of radiation treatment, and after radiation treatment). Imaging with MRI will be performed as per disease site standards.
* Genomic testing of biopsy sample Receives: Diagnostic Test: MRI IMAGING |
| Vulvar Cancer Cohort | Experimental | The research study procedures include:
* Screening for eligibility
* Three MRI scans prior to start of standard cancer treatment, in the middle, and at the end of radiation treatment). Imaging with MRI will be performed as per disease site standards. Receives: Diagnostic Test: MRI IMAGING |
| Pediatric Glioma Cohort | Experimental | The research study procedures include:
* Screening for eligibility
* Three MRI scans prior to start of standard cancer treatment, in the middle, and at the end of radiation treatment). Imaging with MRI will be performed as per disease site standards. Receives: Diagnostic Test: MRI IMAGING |
| Sarcoma Cohort | Experimental | The research study procedures include: • Screening for eligibility • Three MRI scans prior to start of standard cancer treatment, in the middle, and at the end of radiation treatment). Imaging with MRI will be performed as per disease site standards. Receives: Diagnostic Test: MRI IMAGING |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of acquiring serial MRI scans on an MRI simulator during treatment with radiation therapy
90% lower confidence limit (LCL) on the true feasibility rate. Feasibility is defined as successfully enrolling patients, acquiring MRI data at all timepoints, identifying the target on MRI data obtained at all timepoints, and processing MRI data at all timepoints to yield pre-specified MRI-derived measurements.
Measured: 1 year
Ability to measure disease control (for imaging registry expansion cohort)
Validating a previously developed predictive model to identify the most likely area of recurrence using MRI-based features.
Measured: 2 years
Secondary outcomes (1)
Dosimetric change
For subprotocols studying the adaptive treatment, the secondary objective is dosimetric change in the in silico adaptive radiation therapy plans, without delivering adaptive plans in Phase I.
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 posted6 Dec 2019
- Study start15 Jan 2020
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 149 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Leeman, MD, Dana-Farber Cancer Institute
- Investigators
- Jonathan Leeman, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04188535
- Sponsor's protocol ID
- 19-573
- Acronym
- RELAY
- Status last verified
- Aug 2026
- First submitted
- 4 Dec 2019
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RELAY: Repeated Magnetic Resonance Imaging Examinations to Analyze and Assess Your Cancer: A Prospective Study on the Use of Serial Magnetic Resonance Imaging in the Assessment of Changes During Treatment With Radiation Therapy
- ClinicalTrials.gov ID
- NCT04188535
- Acronym / sponsor ID
- RELAY / 19-573
- Conditions
- Glioblastoma, Esophageal Cancer, Radiotherapy, Magnetic Resonance Imaging, MRI, Prostate Cancer
- Keywords
- Glioblastoma, Esophageal Cancer, Radiotherapy, Magnetic Resonance Imaging, MRI, Prostate Cancer, Vulvar Cancer, Pediatric Glioblastoma Multiforme
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 149 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 6 Dec 2019 (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 is a phase 1 study to determine the feasibility and utility of using serial magnetic resonance imaging (MRI) to assess treatment response during and after radiation therapy (standard of care cancer treatment) for participants with advanced esophageal cancer, glioblastoma, prostate cancer, vulvar cancer or pediatric glioma.
The research study procedures include three MRI scans (one before, one during, and one after standard of care cancer radiation therapy) for participants with advanced esophageal cancer, glioblastoma, prostate cancer, vulvar cancer or pediatric glioma.
The research study procedures include:
- Screening for eligibility
- Three MRI scans
Detailed description
This is a phase 1, non-randomized, open-label study evaluating feasibility of serial MRI, with an option for an expansion cohort. The optional expansion cohort is a prospective imaging registry evaluating imaging biomarkers as predictors of disease control with standard of care treatment.
This research study is a feasibility study, meaning that it is the first time that investigators at this institution are examining the process of getting multiple MRIs during radiation treatment.
The U.S. Food and Drug Administration (FDA) has cleared this MRI scanner for use.
Participants who fulfill eligibility criteria will be entered into the trial.
The research study procedures include screening for eligibility, and three MRI scans. MRI imaging will be performed as per disease site standards.
A total of 149 participants will be enrolled in this trial:
- 13 participants in the esophageal cancer cohort
- 10 participants in the initial glioblastoma cohort and 36 participants in the image registry expansion cohort
- 10 participants in the prostate cancer cohort and 50 participants in the image registry expansion cohort
- 10 participants in the vulvar cancer cohort
- 10 participants in the pediatric glioma cohort
- 10 participants in the sarcoma cohort
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Esophageal Cohort | Experimental | Diagnostic Test: MRI IMAGINGThe research study procedures include: * Screening for eligibility * Three MRI scans (prior to start of standard cancer treatment, in the middle, and at the end of radiation treatment). Imaging with MRI will be performed as per disease site standards. |
| Glioblastoma Cohort | Experimental | Diagnostic Test: MRI IMAGINGThe research study procedures include: * Screening for eligibility * Three MRI scans prior to start of standard cancer treatment, in the middle, and at the end of radiation treatment). Imaging with MRI will be performed as per disease site standards. |
| Glioblastoma Expansion Cohort Serial MR Imaging Registry | Experimental | Diagnostic Test: MRI IMAGINGThe research study procedures include: * Screening for eligibility * Three MRI scans prior to start of standard cancer treatment, in the middle, and at the end of radiation treatment). Imaging with MRI will be performed as per disease site standards. |
| Prostate Cancer Cohort | Experimental | Diagnostic Test: MRI IMAGINGThe research study procedures include: * Screening for eligibility * Three MRI scans prior to start of androgen deprivation therapy, prior to the start of radiation treatment, and after radiation treatment). Imaging with MRI will be performed as per disease site standards. * Genomic testing of biopsy sample |
| Prostate Cancer Expansion Cohort Serial MR Imaging Registry | Experimental | Diagnostic Test: MRI IMAGINGThe research study procedures include: * Screening for eligibility * Three MRI scans prior to start of androgen deprivation therapy, prior to the start of radiation treatment, and after radiation treatment). Imaging with MRI will be performed as per disease site standards. * Genomic testing of biopsy sample |
| Vulvar Cancer Cohort | Experimental | Diagnostic Test: MRI IMAGINGThe research study procedures include: * Screening for eligibility * Three MRI scans prior to start of standard cancer treatment, in the middle, and at the end of radiation treatment). Imaging with MRI will be performed as per disease site standards. |
| Pediatric Glioma Cohort | Experimental | Diagnostic Test: MRI IMAGINGThe research study procedures include: * Screening for eligibility * Three MRI scans prior to start of standard cancer treatment, in the middle, and at the end of radiation treatment). Imaging with MRI will be performed as per disease site standards. |
| Sarcoma Cohort | Experimental | Diagnostic Test: MRI IMAGINGThe research study procedures include: • Screening for eligibility • Three MRI scans prior to start of standard cancer treatment, in the middle, and at the end of radiation treatment). Imaging with MRI will be performed as per disease site standards. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participants must have a confirmed malignancy requiring radiation therapy.
- Age: 18 years or older except where otherwise specified in subprotocol.
- ECOG performance status ≤2 (Karnofsky ≥60%)
- Ability to understand and the willingness to sign a written informed consent document.
- Any further criteria listed in the specific disease site subprotocol.
Key exclusion criteria (3 listed)
- Disease-specific exclusion criteria will be specified in a subprotocol.
- For MRI involving contrast, history of allergic reactions attributed to gadolinium-based IV contrast. If patient will not receive contrast, this is not applicable and kidney function will not affect eligibility.
- Inability to undergo magnetic resonance imaging (MRI).
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 |
|---|---|---|
| MRI IMAGINGImaging with MRI will be performed as per disease site standards. | Diagnostic test | Esophageal Cohort, Glioblastoma Cohort, Glioblastoma Expansion Cohort Serial MR Imaging Registry, Pediatric Glioma Cohort, Prostate Cancer Cohort, Prostate Cancer Expansion Cohort Serial MR Imaging Registry, Sarcoma Cohort, Vulvar Cancer Cohort |
Primary outcome
Feasibility of acquiring serial MRI scans on an MRI simulator during treatment with radiation therapy
Time frame: 1 year
90% lower confidence limit (LCL) on the true feasibility rate. Feasibility is defined as successfully enrolling patients, acquiring MRI data at all timepoints, identifying the target on MRI data obtained at all timepoints, and processing MRI data at all timepoints to yield pre-specified MRI-derived measurements.
Ability to measure disease control (for imaging registry expansion cohort)
Time frame: 2 years
Validating a previously developed predictive model to identify the most likely area of recurrence using MRI-based features.
1 secondary outcome
Dosimetric change
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Jonathan Leeman, MD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI IMAGING in people with Glioblastoma and Esophageal Cancer, run by Dana-Farber Cancer Institute at 2 sites 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 11 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Leeman, MD ((617) 732-6452, JONATHANE_LEEMAN@DFCI.HARVARD.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of acquiring serial MRI scans on an MRI simulator during treatment with radiation therapy (time frame: 1 year). 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?
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 2 Sep 2026.