Prostate CancerJUMPNCT04545957
Jump: MR Simulation For Radiation Therapy Master Protocol
A study testing MRI Simulator and Radiation Therapy in people with Prostate Cancer and Recurrent Adenocarcinoma, run by Brigham and Women's Hospital at 2 sites in United States.
Trial summary
This is a master protocol for a prospective Phase I-II study evaluating feasibility and efficacy of incorporating magnetic resonance imaging (MRI) simulation into the planning of radiation treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Recurrent Adenocarcinoma, Liver Cancer
- What is being tested?
- MRI Simulator and Radiation Therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Oct 2020to 22 Oct 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
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
- Ability to understand and the willingness to sign a written informed consent document.
- Disease-specific eligibility criteria will be specified in the appropriate subprotocol.
Who cannot join
- For MRI involving contrast, history of allergic reactions attributed to gadolinium based IV contrast. Note: If patient will not receive contrast, this is not applicable
- Participants who cannot undergo an MRI
- Disease-specific exclusion criteria will be specified in the appropriate subprotocol
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
Raymond Mak, MD, rmak@partners.org
Raymond Mak, MD
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Raymond Mak, MD, rmak@partners.org
Raymond Mak, MD
About this study
Official title: Judging MR Simulation Procedures: A Phase I-II Study of the Use of Magnetic Resonance Imaging Simulation in the Planning of Radiation Treatments
This is a master protocol for a prospective Phase I-II study evaluating feasibility and efficacy of incorporating magnetic resonance imaging (MRI) simulation into the planning of radiation treatments.
Read the detailed description
This is a Phase I/II clinical trial. A Phase I clinical trial tests the feasibility and safety of an investigational intervention. "Investigational" means that the process targeting high doses of radiation to the tumor based on MRI is still being studied. This research study is a Feasibility Study, which means it is the first-time investigators at this institution are examining this type of MR-guided dose planning. The U.S. Food and Drug Administration (FDA) has cleared MRI planning for use.
- In Phase I of this study, will prospectively determine the feasibility of using an MRI simulator to plan radiation therapy.
- In Phase II, the efficacy of adjusting RT based on MRI simulation will be explored, either by utilizing an MRI-simulation and synthetic CT to plan treatment or by dose-painting based on functional MRI data
- Being tested
- MRI Simulator, Radiation Therapy
- Keywords
- Prostate Cancer, Recurrent Adenocarcinoma, Liver Cancer, Head and Neck Cancer
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma, Liver Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI SimulatorDevice
Radiation mapping to define the target for radiation.acquiring MR data at the specified timepoint in a patient's care plan and ability to identify the radiation target and develop a radiation therapy plan on the MR data.
Radiation TherapyRadiation
In Phase I, radiation will be institutional standard per disease site. In Phase II, either radiation according to MR-based dose painting or adjusted RT. These adjusted doses and/or RT will vary per disease site and will be pre-specified in the subprotocols.
| Study group | Role | What they receive |
|---|---|---|
| Phase I MRI Simulation | Experimental | This research study involves a screening period to determine eligibility.
- Radiation mapping to define the target for radiation.acquiring MR data at the specified timepoint in a patient's care plan and ability to identify the radiation target and develop a radiation therapy plan on the MR data. Receives: Device: MRI Simulator; Radiation: Radiation Therapy |
| Phase II MR Simulation Protocol: Track A | Experimental | MR-only Radiation Therapy Simulation MRI-simulation and synthetic CT to plan treatment Receives: Device: MRI Simulator; Radiation: Radiation Therapy |
| Phase II MR Simulation Protocol: Track B | Experimental | Adjusted Margin or / Dose Painted RT Based on Imaging of MR Simulator (e.g. biological imaging or higher resolution imaging) Receives: Device: MRI Simulator; Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of acquiring MRI simulation prior to radiation therapy planning
Feasibility is defined as successfully enrolling patients, successfully acquiring MR data at the specified timepoint in a patient's care plan and ability to identify the radiation target and develop a radiation therapy plan on the MR data
Measured: 1 Year
Proportion of patients with QOL decline exceeding 2 x MID
12 points; MID of the EPIC-26 urinary irritative/obstructive domain is 6 points) measured by EPIC-26 urinary irritation/obstruction domain from baseline to 2 years
Measured: baseline up to 24 months
Secondary outcomes (8)
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Measured: 24 Months
MRI evidence of disease at 2 years from treatment initiation.
Measured: 24 Months
PSA progression (nadir + 2) at 2 years from treatment initiation
Measured: 24 months
Progression free survival
Measured: 24 months
Change in target volumes between CT simulation and MRI simulation
To ascertain the effects of MRI simulation on size of target volumes and OAR, the volume (cc) will be compared between CT vs MR simulation by t-test for normal data or Wilcoxon signed-rank test if data does not follow a normal distribution. The extent of overlap calculated with the Sorensen-Dice coefficient and Hausdorff distance.
Measured: 24 Months
Change in coverage of target volumes between CT simulation and MRI simulation
The dose to OARS using the CT-simulation and MR-simulation derived plans will be compared using the t-test for normal data or Wilcoxon signed-rank test if data does not follow a normal distribution.
Measured: 24 Months
Change in dose to organs at risk (OARs) between CT simulation and MRI simulation
The dose to OARS using the CT-simulation and MR-simulation derived plans will be compared using the t-test for normal data or Wilcoxon signed-rank test if data does not follow a normal distribution.
Measured: 24 Months
Performance of the synthetic CT in RT planning
To assess performance of the synthetic CT in RT planning, fluence patterns from the synthetic CT plan will be copied onto the CT simulation electron density grids and dose recalculated. Accuracy of synthetic CT dose calculations to target volumes and OARs will be assessed with a goal of <1% difference in target and OAR dose between synthetic CT plans and CT simulation plans
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2020
- Study start14 Oct 2020
- Primary completion22 Oct 2030 (estimated)
- Study completion22 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raymond Mak, Brigham and Women's Hospital
- Investigators
- Raymond Mak, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04545957
- Sponsor's protocol ID
- 19-759
- Acronym
- JUMP
- Status last verified
- Jul 2026
- First submitted
- 4 Sep 2020
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Judging MR Simulation Procedures: A Phase I-II Study of the Use of Magnetic Resonance Imaging Simulation in the Planning of Radiation Treatments
- ClinicalTrials.gov ID
- NCT04545957
- Acronym / sponsor ID
- JUMP / 19-759
- Keywords
- Prostate Cancer, Recurrent Adenocarcinoma, Liver Cancer, Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 22 Oct 2030 (estimated)
- Study completion
- 22 Oct 2030 (estimated)
- First posted
- 11 Sep 2020 (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 master protocol for a prospective Phase I-II study evaluating feasibility and efficacy of incorporating magnetic resonance imaging (MRI) simulation into the planning of radiation treatments.
Detailed description
This is a Phase I/II clinical trial. A Phase I clinical trial tests the feasibility and safety of an investigational intervention. "Investigational" means that the process targeting high doses of radiation to the tumor based on MRI is still being studied. This research study is a Feasibility Study, which means it is the first-time investigators at this institution are examining this type of MR-guided dose planning. The U.S. Food and Drug Administration (FDA) has cleared MRI planning for use.
- In Phase I of this study, will prospectively determine the feasibility of using an MRI simulator to plan radiation therapy.
- In Phase II, the efficacy of adjusting RT based on MRI simulation will be explored, either by utilizing an MRI-simulation and synthetic CT to plan treatment or by dose-painting based on functional MRI data
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase I MRI Simulation | Experimental | Device: MRI Simulator, Radiation: Radiation TherapyThis research study involves a screening period to determine eligibility. - Radiation mapping to define the target for radiation.acquiring MR data at the specified timepoint in a patient's care plan and ability to identify the radiation target and develop a radiation therapy plan on the MR data. |
| Phase II MR Simulation Protocol: Track A | Experimental | Device: MRI Simulator, Radiation: Radiation TherapyMR-only Radiation Therapy Simulation MRI-simulation and synthetic CT to plan treatment |
| Phase II MR Simulation Protocol: Track B | Experimental | Device: MRI Simulator, Radiation: Radiation TherapyAdjusted Margin or / Dose Painted RT Based on Imaging of MR Simulator (e.g. biological imaging or higher resolution imaging) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants must have a confirmed malignancy requiring radiation therapy.
- Age: 18 years or older
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
- Ability to understand and the willingness to sign a written informed consent document.
- Disease-specific eligibility criteria will be specified in the appropriate subprotocol.
Key exclusion criteria (3 listed)
- For MRI involving contrast, history of allergic reactions attributed to gadolinium based IV contrast. Note: If patient will not receive contrast, this is not applicable
- Participants who cannot undergo an MRI
- Disease-specific exclusion criteria will be specified in the appropriate subprotocol
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 SimulatorRadiation mapping to define the target for radiation.acquiring MR data at the specified timepoint in a patient's care plan and ability to identify the radiation target and develop a radiation therapy plan on the MR data. | Device | Phase I MRI Simulation, Phase II MR Simulation Protocol: Track A, Phase II MR Simulation Protocol: Track B |
| Radiation TherapyIn Phase I, radiation will be institutional standard per disease site. In Phase II, either radiation according to MR-based dose painting or adjusted RT. These adjusted doses and/or RT will vary per disease site and will be pre-specified in the subprotocols. | Radiation | Phase I MRI Simulation, Phase II MR Simulation Protocol: Track A, Phase II MR Simulation Protocol: Track B |
Primary outcome
Feasibility of acquiring MRI simulation prior to radiation therapy planning
Time frame: 1 Year
Feasibility is defined as successfully enrolling patients, successfully acquiring MR data at the specified timepoint in a patient's care plan and ability to identify the radiation target and develop a radiation therapy plan on the MR data
Proportion of patients with QOL decline exceeding 2 x MID
Time frame: baseline up to 24 months
12 points; MID of the EPIC-26 urinary irritative/obstructive domain is 6 points) measured by EPIC-26 urinary irritation/obstruction domain from baseline to 2 years
8 secondary outcomes
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: 24 Months
MRI evidence of disease at 2 years from treatment initiation.
Time frame: 24 Months
PSA progression (nadir + 2) at 2 years from treatment initiation
Time frame: 24 months
Progression free survival
Time frame: 24 months
Change in target volumes between CT simulation and MRI simulation
Time frame: 24 Months
Change in coverage of target volumes between CT simulation and MRI simulation
Time frame: 24 Months
Change in dose to organs at risk (OARs) between CT simulation and MRI simulation
Time frame: 24 Months
Performance of the synthetic CT in RT planning
Time frame: 24 Months
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 20 Jul 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.
Raymond Mak, MD principal investigator
Brigham and Women's Hospital
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 Simulator and Radiation Therapy in people with Prostate Cancer and Recurrent Adenocarcinoma, run by Brigham and Women's Hospital 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 5 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 20 Jul 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 Raymond Mak, MD (617-632-5734, rmak@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of acquiring MRI simulation prior to radiation therapy planning (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 20 Jul 2026.