Clinical trial · Interventional
Stereotactic Magnetic Resonance Guided Radiation Therapy
A Master Protocol of Stereotactic Magnetic Resonance Guided Adaptive Radiation Therapy (SMART)
NCT04115254CI-TRIAL-00097183recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (13)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adrenal Metastases | — | UNRESOLVED | — |
| Borderline Resectable Pancreatic Carcinoma | Pancreatic Carcinoma | CURATED_BROADER | 0.78 |
| Brain Metastases | — | UNRESOLVED | — |
| Liver Metastases | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Mesothelioma | Malignant Mesothelioma | CURATED_EXACT | 0.92 |
| Metachronous Nodal Metastases | — | UNRESOLVED | — |
| Oligoprogressive Nodal Metastases | — | UNRESOLVED | — |
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MR-guided Linac | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (19)
- type
- EXPERIMENTAL
- label
- PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Pancreatic
- description
- SMART will be administered per each individual disease site standards
- interventionNames
- Radiation: MR-guided Linac
- type
- EXPERIMENTAL
- label
- PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Renal
- description
- SMART will be administered per each individual disease site standards
- interventionNames
- Radiation: MR-guided Linac
- type
- EXPERIMENTAL
- label
- PHASE 1: SBRT MR IMAGE GUIDANCE/ADAPTATION--Central Lung
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLeeman 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. PMID 40794880