ClinicalTrials.gg
RecruitingNCT04188535RELAYUpdated Sep 2, 2026

Serial MRI Scans During Radiation Therapy

An interventional study of MRI IMAGING in Glioblastoma, Esophageal Cancer and Radiotherapy, sponsored by Dana-Farber Cancer Institute. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by Dana-Farber Cancer Institute · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Jan 2020; still recruiting 6 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
149
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 16 studies in Glioblastoma by Dana-Farber Cancer Institute — 1 open to participants now, 4 under way, none of them phase 3. Glioblastoma · Dana-Farber Cancer Institute.

Planned enrollment
Largest of 13
149 · median 45
Started
2020
with 1 other
No phase
2 of 16
1 open now
Registered
14th of 16
by date

Among the 16 studies in Glioblastoma by Dana-Farber Cancer Institute, this one has the largest planned enrollment of the 13 interventional ones, is one of 2 that started in 2020, is one of 2 with no phase, and was the 14th registered.

By phase

16 studies; the count open now beside each. This study's row is marked.

Phase 29 · 0 open
Phase 14 · 0 open
No phasethis study2 · 1 open
Phase 1/21 · 0 open

By the year they started

First in 2000; this study’s year is marked. 2 started in 2020.

Size and results

Median enrollment 45 across the 13 interventional studies. Of the 11 that completed or were terminated, 6 (55%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 16 studies in Glioblastoma by Dana-Farber Cancer Institute, or all of them as a file.
02

Study 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 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
03

Conditions studied

  • Glioblastoma
  • Esophageal Cancer
  • Radiotherapy
  • Magnetic Resonance Imaging
  • MRI
  • Prostate Cancer
  • Vulvar Cancer
  • Pediatric Glioblastoma Multiforme
  • Sarcoma

Keywords

  • Glioblastoma
  • Esophageal Cancer
  • Radiotherapy
  • Magnetic Resonance Imaging
  • MRI
  • Prostate Cancer
  • Vulvar Cancer
  • Pediatric Glioblastoma Multiforme
  • sarcoma
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants must have a confirmed requiring radiation therapy.
  • Age: 18 years or older except where otherwise specified in subprotocol.
  • performance status ≤2 ( ≥60%)
  • Ability to understand and the willingness to sign a written document.
  • Any further criteria listed in the specific disease site subprotocol.
  • (Esophageal cohort) Patients must be considered appropriate candidates for chemoradiation therapy followed by esophagectomy. Patients must have an endoscopic ultrasound done or scheduled to be done at the baseline visit.
  • (Glioblastoma cohort) Patients with a 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 -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.

Exclusion criteria

Exclusion Criteria:

  • 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).
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
Single (Outcomes assessor)
Enrollment
149 participants (estimated)

Study arms

  • Experimental
    Esophageal Cohort

    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.

    Diagnostic Test: MRI IMAGING

  • Experimental
    Glioblastoma Cohort

    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.

    Diagnostic Test: MRI IMAGING

  • Experimental
    Glioblastoma Expansion Cohort Serial MR Imaging Registry

    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.

    Diagnostic Test: MRI IMAGING

  • Experimental
    Prostate Cancer Cohort

    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

    Diagnostic Test: MRI IMAGING

  • Experimental
    Prostate Cancer Expansion Cohort Serial MR Imaging Registry

    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

    Diagnostic Test: MRI IMAGING

  • Experimental
    Vulvar Cancer Cohort

    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.

    Diagnostic Test: MRI IMAGING

  • Experimental
    Pediatric Glioma Cohort

    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.

    Diagnostic Test: MRI IMAGING

  • Experimental
    Sarcoma Cohort

    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.

    Diagnostic Test: MRI IMAGING

Interventions

  • Diagnostic testMRI IMAGING

    Imaging with MRI will be performed as per disease site standards.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

  2. 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.

    Time frame: 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.

    Time frame: 1 year

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: Data can be shared no earlier than 1 year following the date of publication.

Access criteria: DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2020 (actual). Primary completion is estimated for Jul 2030, 126 months after the start.

Of 131 non-industry interventional studies with no phase under Glioblastoma, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 97. This study's planned 126 months is above that.

Counting every sponsor, half of 149 studies reached it within 54 months; a quarter within 36 and three quarters within 88.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 4, 2019
First posted
Dec 6, 2019
StartActual
Jan 15, 2020
Primary completionEst.
Jul 31, 2030
CompletionEst.
Jul 31, 2030
Last update
Sep 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04188535
Responsible party
Jonathan Leeman, MD (Principal Investigator, Dana-Farber Cancer Institute) — Principal investigator
First posted
Dec 6, 2019
Start date
Jan 15, 2020
Primary completion
Jul 31, 2030 (estimated)
Completion
Jul 31, 2030 (estimated)
Last update
Sep 2, 2026

Study contacts

Jonathan Leeman, MD
Contact
JONATHANE_LEEMAN@DFCI.HARVARD.EDU
(617) 732-6452
Jonathan Leeman, MD
principal investigator · Dana-Farber Cancer Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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