Nano-SMART: Nanoparticles With MR Guided SBRT in Centrally Located Lung Tumors and Pancreatic Cancer

Study summary

This research study is being done to help determine the safety and efficacy of gadolinium based nanoparticle, Activation and Guidance of Irradiation X (AGuIX), used in conjunction with MR-guided stereotactic body radiation therapy (SBRT) in the treatment of pancreatic cancer and lung tumors.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedAGuIX and Radiotherapy

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated May 14, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?Dana-Farber Cancer Institute

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1 / Phase 2
Sponsor: Dana-Farber Cancer Institute
Interventions being studied: Drug: AGuIX; Radiation: Radiotherapy

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Early-stage or resectable→

Treatment approach

Radiation therapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Patients should have clinical, radiographical, cytological, or histological confirmation of NSCLC or lung or nodal metastases from another primary cancer defined as within or touching the zone of the proximal bronchial tree, defined as a volume 2 cm in all directions around the trachea and proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus right and left lower lobe bronchi). Tumors that are immediately adjacent (\<1 cm) to mediastinal or pericardial pleura or other radiation-sensitive organs such as the esophagus and brachial plexus also are considered central tumors and are eligible for this protocol. OR Histologically or cytologically confirmed pancreatic ductal adenocarcinoma of the pancreatic head, body or tail.
Participants must have measurable disease, defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease. Eligible NSCLC patients must have no evidence of nodal involvement (N0), and disease has to be determined unresectable by a thoracic oncologist or the patient is medically inoperable.
Locally advanced, unresectable pancreatic cancer as determined by a pancreaticobiliary surgeon as part of a multidisciplinary discussion at the investigative site, including multi-phasic CT demonstrating tumor abutment of the SMA or celiac axis, SMV or PV involvement which is not resectable without vascular reconstruction.
Completion of at least 3 months of standard induction chemotherapy for LAPC, which should consist of either FOLFIRINOX, gemcitabine and nab-paclitaxel, or another standard combination of induction chemotherapy agent, with a washout period no longer than 10 weeks prior to first dose of study drug.
No evidence of distant metastasis.
Pancreatic or central NSCLC size ≤ 5cm.
Age 18 years or older.
ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
Ability to understand and follow the breathing instructions involved in the respiratory gating procedure.
Participants must have normal organ and marrow function as defined below:
absolute neutrophil count ≥1,500/mcL
platelets ≥100,000/mcL
total bilirubin within normal institutional limits
AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
creatinine within normal institutional limits OR
Creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
The effects of AGuIX on the developing human fetus are unknown. For this reason, as well as the known teratogenic effects of radiation, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
Ability to understand and the willingness to sign a written informed consent document.

Reasons someone may not be able to joinExclusion criteria

Participants who have had prior radiation therapy to the chest or abdomen that would overlap with the current treatment field.
Participants who are receiving any other investigational agents.
Participants with known metastatic disease.
History of allergic reactions attributed to gadolinium-based IV contrast.
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant women are excluded from this study because AGuIX is contrast agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with AGuIX, breastfeeding should be discontinued if the mother is treated with AGuIX.
Severe claustrophobia or anxiety.
Known HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with AGuIX. In addition, these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.
Active duodenal or gastric ulcer disease or evidence of tumor invasion of the bowel or stomach based on endoscopy.
Presence of a duodenal stent.
Unable to undergo magnetic resonance imaging (MRI) due to any of the following: 1. Presence of MRI-incompatible metal material or devices in the human body 2. MRI-incompatible Pacemaker or defibrillator 3. Insulin pump 4. Aneurysm clip 5. Artificial heart valve 6. Cochlear implant 7. Shrapnel or gunshot injury 8. Cataract surgery with implant unsafe for MRI

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Brigham and Women's HospitalBoston, Massachusetts
Dana Farber Cancer InstituteBoston, Massachusetts

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 14, 2026. Always confirm current availability with the study team.

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