Pancreas CancerNCT04115254
Stereotactic Magnetic Resonance Guided Radiation Therapy
A study testing MR-guided Linac in people with Pancreas Cancer and Lung Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
This is a master prospective Phase I-II trial evaluating feasibility and efficacy of stereotactic magnetic resonance (MR) guided adaptive radiation therapy (SMART) in patients with cancer. The phase 1 study will evaluate the feasibility and safety of delivering SMART in patients with cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer, Lung Cancer, Renal Cancer
- What is being tested?
- MR-guided Linac
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 397 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Oct 2019to Jun 2028
- 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 stereotactic body radiation therapy. See specific disease site cohorts for more details.
- Tumor size ≤ 7cm
- Age 18 years of older.
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
- Ability to understand and the willingness to sign a written informed consent document.
- Specific eligibility requirements for each disease site with be covered in each specific cohort.
Who cannot join
- Specific exclusion requirements for each disease site with be covered in each specific cohort
- History of allergic reactions attributed to gadolinium-based IV contrast.
- -- Note: If a patient will not receive contrast, this is not applicable
- Pregnant women are excluded from this study.
- Severe claustrophobia or anxiety
- Participants who cannot undergo an 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 & Women's Hospital
Boston, Massachusetts, 02115
Jonathan Leeman, MD
Jonathan Leeman, MD
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Jonathan Leeman, MD
Jonathan Leeman, MD
About this study
Official title: A Master Protocol of Stereotactic Magnetic Resonance Guided Adaptive Radiation Therapy (SMART)
This is a master prospective Phase I-II trial evaluating feasibility and efficacy of stereotactic magnetic resonance (MR) guided adaptive radiation therapy (SMART) in patients with cancer.
- The phase 1 study will evaluate the feasibility and safety of delivering SMART in patients with cancer.
- Phase 2 will evaluate efficacy of SMART with specific reference to tumor control and improvement in patient reported outcome measures
Read the detailed description
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 radiation to treat cancer.
The U.S. Food and Drug Administration (FDA) has approved this device as a treatment option for cancer.
In this research study, the investigators are hoping to determine if adjusting radiation treatments based on daily MRI has a feasible way to deliver radiation for participants with pancreatic, lung or renal cancer.
- Conditions
- Pancreas Cancer, Lung Cancer, Renal Cancer, Adrenal Metastases, Prostate Cancer, Liver Metastases
- Being tested
- MR-guided Linac
- Keywords
- Magnetic Resonance Imaging (MRI), MRIdian Linear Accelerator, Pancreas Cancer, Lung Cancer, Renal Cancer, Adrenal Metastases, Prostate Cancer, Liver Metastases, Oligoprogressive, Metachronous, Synchronous, Spine, Prostate Boost, Pelvic Re Irradiation
- Medical subject headings
- Pancreatic Neoplasms, Lung Neoplasms, Kidney Neoplasms, Prostatic Neoplasms, Mesothelioma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-guided LinacRadiation
Radiation will be delivered on an MR-guided Linear Accelerator
| Study group | Role | What they receive |
|---|---|---|
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pancreatic | Experimental | SMART will be administered per each individual disease site standards Receives: Radiation: MR-guided Linac |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Renal | Experimental | SMART will be administered per each individual disease site standards Receives: Radiation: MR-guided Linac |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Central Lung | Experimental | SMART will be administered per each individual disease site standards Receives: Radiation: MR-guided Linac |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Adrenal Metastases | Experimental | SMART will be administered per each individual disease site standards Receives: Radiation: MR-guided Linac |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Liver Metastases | Experimental | SMART will be administered per each individual disease site standards Receives: Radiation: MR-guided Linac |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Metachronous Oligometastatic Nodes | Experimental | SMART will be administered per each individual disease site standards Receives: Radiation: MR-guided Linac |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Oligoprogressive Oligometastatic Nodes/Soft Tissue | Experimental | SMART will be administered per each individual disease site standards Receives: Radiation: MR-guided Linac |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Synchronous Oligometastatic Nodes/Soft Tissue | Experimental | SMART will be administered per each individual disease site standards Receives: Radiation: MR-guided Linac |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate | Experimental | SMART will be administered per each individual disease site standards Receives: Radiation: MR-guided Linac |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Borderline Resectable Pancreas | Experimental | SMART will be administered per each individual disease site standards Receives: Radiation: MR-guided Linac |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Brain Metastases | Experimental | SMART will be administered per each individual disease site standards Receives: Radiation: MR-guided Linac |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mesothelioma | Experimental | SMART will be administered per each individual disease site standards Receives: Radiation: MR-guided Linac |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate Boost | Experimental | SMART will be administered per each individual disease site standards Receives: Radiation: MR-guided Linac |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pelvic Re-Irradiation | Experimental | SMART will be administered per each individual disease site standards Receives: Radiation: MR-guided Linac |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Spine | Experimental | SMART will be administered per each individual disease site standards Receives: Radiation: MR-guided Linac |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Single-Fraction Kidney Tumors | Experimental | SMART will be administered per each individual disease site standards Receives: Radiation: MR-guided Linac |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--1/3 Fraction for Oligometastatases in the Abdomen/Pelvis | Experimental | SMART will be administered per each individual disease site standards Receives: Radiation: MR-guided Linac |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Post-Operative Radiation Therapy in Lung Cancer | Experimental | SMART will be administered per each individual disease site standards Receives: Radiation: MR-guided Linac |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mediastinal and Hilar Lymph Nodes | Experimental | SMART will be administered per each individual disease site standards Receives: Radiation: MR-guided Linac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery Success Rate for SMART across multiple tumors-Phase I
Enrolling patients and delivering SMART on the MR Linac
Measured: 1 year
Tumor visualization-Phase I
Assessing tumor using MR guidance before, during and after MR-guided treatment patient
Measured: 1 Year
Plan creation-Phase I
Generating adaptive plans
Measured: 1 Year
Rate of Improvement in Tumor Control-Phase II
Statistical power will be defined in each cohort individually and will be specific to each disease site tested.
Measured: 1 Year
Secondary outcomes (6)
Number of Patients with Acute Toxicity-Phase I
Any related ≥ Grade 3 AE which is possibly, probably or definitely related to SMART
Measured: 90 Days
Duration of treatment-Phase 1
Duration of treatment with goal of >80% of cases treated within 90 minutes
Measured: 90 Days
Number of treatment fractions-Phase1
Number of treatment fractions that would have resulted in unacceptably high dose (exceeding constraint) to an OAR without SMART
Measured: 90 Days
Number of Participants with long term toxicity-Phase II
assessing long-term (12 month) toxicity in patients receiving SMART
Measured: 365 Days
Disease Specific Survival Rate-Phase II
Kaplan-Meier curve estimates
Measured: 365 Days
Overall Survival Rate-Phase II
Kaplan-Meier curve estimates
Measured: 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start22 Oct 2019
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreas CancerStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All participants will be assigned to one treatment arm only depending on their cancer type, and will be taken off study once treatment and follow up are complete.
- Masking
- None (open label)
- Enrolment
- 397 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, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04115254
- Sponsor's protocol ID
- 19-353
- Status last verified
- Nov 2025
- First submitted
- 26 Sep 2019
- Last updated
- 13 Nov 2025
- 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: Dr. Jonathan Leeman (jonathane\_leeman@dfci.harvard.edu). 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.
Publications
Leeman JE, Shin KY, Droznin A, Catalano P, Cagney DN, Singer L, Oniyangi RD, Zhai K, Benham G, Chirmade S, Campbell J, Boyle S, Saranteas A, Williams CL, Huynh E, Han Z, Sudhyadhom A, Hu YH, Ferguson D, Singhrao K, Hsu SH, Bredfeldt J, Martin NE, Mancias JD, Mamon HJ, Van Dams R, Venkatachalam V, Tanguturi SK, Huynh MA, Fitzgerald KJ, Elhalawani H, Bitterman DS, Schoenfeld JD, Nguyen P, Haas-Kogan DA, Mak R. Stereotactic magnetic resonance imaging-guided adaptive radiotherapy: a pooled analysis of a master prospective trial. J Natl Cancer Inst. 2025 Nov 1;117(11):2289-2297. doi: 10.1093/jnci/djaf208.
PubMed 40794880
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Master Protocol of Stereotactic Magnetic Resonance Guided Adaptive Radiation Therapy (SMART)
- ClinicalTrials.gov ID
- NCT04115254
- Acronym / sponsor ID
- 19-353
- Conditions
- Pancreas Cancer, Lung Cancer, Renal Cancer, Adrenal Metastases, Prostate Cancer, Liver Metastases
- Keywords
- Magnetic Resonance Imaging (MRI), MRIdian Linear Accelerator, Pancreas Cancer, Lung Cancer, Renal Cancer, Adrenal Metastases, Prostate Cancer, Liver Metastases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 397 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 3 Oct 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 master prospective Phase I-II trial evaluating feasibility and efficacy of stereotactic magnetic resonance (MR) guided adaptive radiation therapy (SMART) in patients with cancer.
- The phase 1 study will evaluate the feasibility and safety of delivering SMART in patients with cancer.
- Phase 2 will evaluate efficacy of SMART with specific reference to tumor control and improvement in patient reported outcome measures
Detailed description
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 radiation to treat cancer.
The U.S. Food and Drug Administration (FDA) has approved this device as a treatment option for cancer.
In this research study, the investigators are hoping to determine if adjusting radiation treatments based on daily MRI has a feasible way to deliver radiation for participants with pancreatic, lung or renal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 19
- Model description
- All participants will be assigned to one treatment arm only depending on their cancer type, and will be taken off study once treatment and follow up are complete.
| Arm | Type | Receives |
|---|---|---|
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pancreatic | Experimental | Radiation: MR-guided LinacSMART will be administered per each individual disease site standards |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Renal | Experimental | Radiation: MR-guided LinacSMART will be administered per each individual disease site standards |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Central Lung | Experimental | Radiation: MR-guided LinacSMART will be administered per each individual disease site standards |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Adrenal Metastases | Experimental | Radiation: MR-guided LinacSMART will be administered per each individual disease site standards |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Liver Metastases | Experimental | Radiation: MR-guided LinacSMART will be administered per each individual disease site standards |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Metachronous Oligometastatic Nodes | Experimental | Radiation: MR-guided LinacSMART will be administered per each individual disease site standards |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Oligoprogressive Oligometastatic Nodes/Soft Tissue | Experimental | Radiation: MR-guided LinacSMART will be administered per each individual disease site standards |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Synchronous Oligometastatic Nodes/Soft Tissue | Experimental | Radiation: MR-guided LinacSMART will be administered per each individual disease site standards |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate | Experimental | Radiation: MR-guided LinacSMART will be administered per each individual disease site standards |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Borderline Resectable Pancreas | Experimental | Radiation: MR-guided LinacSMART will be administered per each individual disease site standards |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Brain Metastases | Experimental | Radiation: MR-guided LinacSMART will be administered per each individual disease site standards |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mesothelioma | Experimental | Radiation: MR-guided LinacSMART will be administered per each individual disease site standards |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate Boost | Experimental | Radiation: MR-guided LinacSMART will be administered per each individual disease site standards |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pelvic Re-Irradiation | Experimental | Radiation: MR-guided LinacSMART will be administered per each individual disease site standards |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Spine | Experimental | Radiation: MR-guided LinacSMART will be administered per each individual disease site standards |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Single-Fraction Kidney Tumors | Experimental | Radiation: MR-guided LinacSMART will be administered per each individual disease site standards |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--1/3 Fraction for Oligometastatases in the Abdomen/Pelvis | Experimental | Radiation: MR-guided LinacSMART will be administered per each individual disease site standards |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Post-Operative Radiation Therapy in Lung Cancer | Experimental | Radiation: MR-guided LinacSMART will be administered per each individual disease site standards |
| PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mediastinal and Hilar Lymph Nodes | Experimental | Radiation: MR-guided LinacSMART will be administered per each individual 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 (6 listed)
- Participants must have a confirmed malignancy requiring stereotactic body radiation therapy. See specific disease site cohorts for more details.
- Tumor size ≤ 7cm
- Age 18 years of older.
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
- Ability to understand and the willingness to sign a written informed consent document.
Key exclusion criteria (6 listed)
- Specific exclusion requirements for each disease site with be covered in each specific cohort
- History of allergic reactions attributed to gadolinium-based IV contrast.
- -- Note: If a patient will not receive contrast, this is not applicable
- Pregnant women are excluded from this study.
- Severe claustrophobia or anxiety
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 |
|---|---|---|
| MR-guided LinacRadiation will be delivered on an MR-guided Linear Accelerator | Radiation | PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--1/3 Fraction for Oligometastatases in the Abdomen/Pelvis, PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Adrenal Metastases, PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Borderline Resectable Pancreas, PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Brain Metastases, PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Central Lung, PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Liver Metastases, PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mediastinal and Hilar Lymph Nodes, PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Mesothelioma, PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Metachronous Oligometastatic Nodes, PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Oligoprogressive Oligometastatic Nodes/Soft Tissue, PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pancreatic, PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pelvic Re-Irradiation, PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Post-Operative Radiation Therapy in Lung Cancer, PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate, PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Prostate Boost, PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Renal, PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Single-Fraction Kidney Tumors, PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Spine, PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Synchronous Oligometastatic Nodes/Soft Tissue |
Primary outcome
Delivery Success Rate for SMART across multiple tumors-Phase I
Time frame: 1 year
Enrolling patients and delivering SMART on the MR Linac
Tumor visualization-Phase I
Time frame: 1 Year
Assessing tumor using MR guidance before, during and after MR-guided treatment patient
Plan creation-Phase I
Time frame: 1 Year
Generating adaptive plans
Rate of Improvement in Tumor Control-Phase II
Time frame: 1 Year
Statistical power will be defined in each cohort individually and will be specific to each disease site tested.
6 secondary outcomes
Number of Patients with Acute Toxicity-Phase I
Time frame: 90 Days
Duration of treatment-Phase 1
Time frame: 90 Days
Number of treatment fractions-Phase1
Time frame: 90 Days
Number of Participants with long term toxicity-Phase II
Time frame: 365 Days
Disease Specific Survival Rate-Phase II
Time frame: 365 Days
Overall Survival Rate-Phase II
Time frame: 365
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 13 Nov 2025.
- Derived from this study: PubMed 40794880Leeman JE, Shin KY, Droznin A, Catalano P, Cagney DN, Singer L, Oniyangi RD, Zhai K, Benham G, Chirmade S, Campbell J, Boyle S, Saranteas A, Williams CL, Huynh E, Han Z, Sudhyadhom A, Hu YH, Ferguson D, Singhrao K, Hsu SH, Bredfeldt J, Martin NE, Mancias JD, Mamon HJ, Van Dams R, Venkatachalam V, Tanguturi SK, Huynh MA, Fitzgerald KJ, Elhalawani H, Bitterman DS, Schoenfeld JD, Nguyen P, Haas-Kogan DA, Mak R. Stereotactic magnetic resonance imaging-guided adaptive radiotherapy: a pooled analysis of a master prospective trial. J Natl Cancer Inst. 2025 Nov 1;117(11):2289-2297. doi: 10.1093/jnci/djaf208.
- 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: Dr. Jonathan Leeman (jonathane_leeman@dfci.harvard.edu). 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
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 MR-guided Linac in people with Pancreas Cancer and Lung 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 6 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: looking for participants now, as of the sponsor's last update on 13 Nov 2025. 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?
Delivery Success Rate for SMART across multiple tumors-Phase I (time frame: 1 year). The study lists 4 primary outcomes in all. 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 NCT04115254, which also lists 1 linked publication.
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 13 Nov 2025.