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Nano-SMART: AGuIX with Radiation for Lung and Pancreatic Cancers

This study is testing a new approach for treating centrally located lung tumors and advanced pancreatic cancer. It combines a special nanoparticle called AGuIX (gadolinium-based nanoparticles) with a type of radiation therapy called stereotactic magnetic resonance-guided adaptive radiation therapy (SBRT). AGuIX is thought to make tumor cells more sensitive to radiation and help doctors see tumors more clearly. The study aims to find the safest dose of AGuIX and then compare how well the combination treatment works against SBRT alone. You may be eligible if you are 18 or older and have certain types of non-small cell lung cancer or pancreatic cancer. The study is currently recruiting 100 participants.

Study design
This is a seamless Phase I/II study with two groups of participants, one for lung tumors and one for pancreatic cancer. The Phase I part determines a safe dose, and the Phase II part is a randomized controlled trial comparing the combination treatment to radiation therapy alone.
What's involved
The study involves screening to see if you are eligible, receiving the study treatment, and attending evaluations and follow-up visits.
Compensation
Not stated in the trial record.
Follow-up
Local control of the cancer will be measured at 12 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04789486

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Dana-Farber Cancer Institute
~100 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:AGuIXRadiotherapy

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Maximum tolerated dose (MTD) Phase 1
Measured over 3 months
+1 more outcome measured

Conditions

Non-small Cell Lung Cancer
Advanced Pancreatic Adenocarcinoma
Unresectable Pancreatic Cancer
Ductal Adenocarcinoma of the Pancreas

Explore related trials

Lung Non-Small Cell CarcinomaPancreatic Carcinoma

Where it's being run

2 sites across 1 states
Massachusetts2

Study leadership

  • Jonathan Leeman, MD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute

Who to contact

Jonathan Leeman, MD
[email protected]
(617) 732-6452
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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.

Exclusion

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:

What this trial measures

  • Maximum tolerated dose (MTD) Phase 13 months

    Evaluated by the occurrence of Dose Limiting Toxicity (DLT) over the duration of the study using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

  • Compare Local Control at 12 months of Maximum tolerated dose MTD - Phase 212 months

    Evaluate SMART + AGuIX local control at 12 months compared to SMART alone. Local control at 12 months is defined as the treated tumor is equal to or less than the tumor volume at start of SMART. Progression would be defined per RECIST criteria