Stereotactic Magnetic Resonance Guided Radiation Therapy

Conditions

Adrenal Metastases, Borderline Resectable Pancreatic Carcinoma, Brain Metastases, Liver Metastases, Lung Cancer, Mesothelioma, Metachronous Nodal Metastases, Oligoprogressive Nodal Metastases, Pancreas Cancer, Prostate Cancer, Renal Cancer, Spine Metastases, Synchronous Nodal Metastases

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

Brief 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. * 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.

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.

2025-11-01

10.1093/jnci/djaf208

MR-guided adaptive versus ITV-based stereotactic body radiotherapy for hepatic metastases (MAESTRO): a randomized controlled phase II trial.

Hoegen P, Zhang KS, Tonndorf-Martini E, Weykamp F, Regnery S, Naumann P, Lang K, Ristau J, Körber SA, Dreher C, Buchele C, Rippke C, Renkamp CK, Paul KM, König L, Büsch C, Krisam J, Sedlaczek O, Schlemmer HP, Niyazi M, Corradini S, Debus J, Klüter S, Hörner-Rieber J.

2022-03-2721 citations

10.1186/s13014-022-02033-2

A Prospective Clinical Trial Evaluating Stereotactic Magnetic Resonance Guided Adaptive Radiation Therapy (SMART) for Pancreatic Cancer.

Roberts HJ, Shin KY, Catalano PJ, Huynh E, Williams CL, Han Z, Vastola M, Ampofo N, Leeman JE, Mamon HJ, Mancias JD, Lam M, Martin NE, Huynh MA, Mak RH, Singer L, Cagney DN.

2021-11-01

10.1016/j.ijrobp.2021.07.429

Interventions

RADIATIONMR-guided Linac

Radiation will be delivered on an MR-guided Linear Accelerator

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention 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.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Delivery Success Rate for SMART across multiple tumors-Phase I	1 year	Enrolling patients and delivering SMART on the MR Linac
Tumor visualization-Phase I	1 Year	Assessing tumor using MR guidance before, during and after MR-guided treatment patient
Plan creation-Phase I	1 Year	Generating adaptive plans
Rate of Improvement in Tumor Control-Phase II	1 Year	Statistical power will be defined in each cohort individually and will be specific to each disease site tested.

Secondary

Measure	Time frame	Description
Disease Specific Survival Rate-Phase II	365 Days	Kaplan-Meier curve estimates
Number of Patients with Acute Toxicity-Phase I	90 Days	Any related ≥ Grade 3 AE which is possibly, probably or definitely related to SMART
Overall Survival Rate-Phase II	365	Kaplan-Meier curve estimates
Duration of treatment-Phase 1	90 Days	Duration of treatment with goal of \>80% of cases treated within 90 minutes
Number of treatment fractions-Phase1	90 Days	Number of treatment fractions that would have resulted in unacceptably high dose (exceeding constraint) to an OAR without SMART
Number of Participants with long term toxicity-Phase II	365 Days	assessing long-term (12 month) toxicity in patients receiving SMART

Countries

United States

Contacts

Primary ContactJonathan Leeman, MD

JONATHANE_LEEMAN@DFCI.HARVARD.EDU617-732-6452

Outcome results

None listed