Actively Recruiting
Nano-SMART: Nanoparticles With MR Guided SBRT in Centrally Located Lung Tumors and Pancreatic Cancer
Led by Dana-Farber Cancer Institute · Updated on 2026-05-14
100
Participants Needed
2
Research Sites
462 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
T
TherAguix S.A.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Nano-SMART: Nanoparticles With MR Guided SBRT in Centrally Located Lung Tumors and Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical, radiographical, cytological, or histological confirmation of non-small cell lung cancer or lung/nodal metastases located centrally near the proximal bronchial tree or adjacent to sensitive organs
- Histological or cytological confirmation of pancreatic ductal adenocarcinoma of the pancreatic head, body, or tail
- Measurable disease with lesion size ≥20 mm by conventional techniques or ≥10 mm by advanced imaging or clinical exam
- Eligible NSCLC patients must have no nodal involvement (N0) and unresectable disease or be medically inoperable
- Locally advanced, unresectable pancreatic cancer determined by multidisciplinary evaluation including CT scan
- Completed at least 3 months of standard induction chemotherapy for pancreatic cancer with a washout period ≤10 weeks before study drug
- No evidence of distant metastasis
- Tumor size ≤5 cm for pancreatic or central NSCLC tumors
- Age 18 years or older
- ECOG performance status ≤2 (Karnofsky ≥60%)
- Ability to understand and follow breathing instructions for respiratory gating
- Normal organ and marrow function defined by specific blood counts and liver and kidney function tests
- Use of adequate contraception for women of childbearing potential and men
- Ability and willingness to sign informed consent
You will not qualify if you...
- Prior radiation therapy to chest or abdomen overlapping the current treatment area
- Receiving other investigational agents
- Known metastatic disease
- Allergic reactions to gadolinium-based IV contrast
- Uncontrolled illnesses including active infections, heart failure, unstable angina, arrhythmias, or psychiatric conditions limiting compliance
- Pregnant or breastfeeding women
- Severe claustrophobia or anxiety
- Known HIV-positive patients on combination antiretroviral therapy
- Active duodenal or gastric ulcers or tumor invasion of bowel or stomach
- Presence of a duodenal stent
- Unable to undergo MRI due to incompatible metal implants, pacemakers, insulin pumps, aneurysm clips, artificial heart valves, cochlear implants, shrapnel, or unsafe cataract surgery implants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
J
Jonathan Leeman, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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