NCT04789486

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

Nano-SMART: An Adaptive Phase I-II Trial of AGuIX Gadolinium-based Nanoparticles With Stereotactic Magnetic Resonance-guided Adaptive Radiation Therapy for Centrally Located Lung Tumors and Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a seamless phase I/II trial with two separate disease groups/cohorts (centrally located lung tumors and locally advanced/unresectable pancreatic ductal adenocarcinoma-LAPC). The Phase I part is determining for each disease group a safe dose-level that will be evaluated in the Phase II component of the study. The phase II part of the study is a randomized controlled trial that tests, for each disease group, the treatment efficacy of stereotactic body radiation therapy (SBRT) in combination with AGuIX gadolinium-chelated polysiloxane based nanoparticles compared to treatment with stereotactic magnetic resonance (MR)-guided adaptive radiation therapy (SMART) alone The U.S. Food and Drug Administration (FDA) has not approved Activation and Guidance of Irradiation X (AGuIX) as a treatment for any disease. AGuIX is a gadolinium-based nanoparticle, gadolinium is the drug used for an MR with contrast. It is believed that the AGuIX may help the radiation received work better by making a tumor more sensitive to the radiation and allowing doctors to see the tumor more clearly. AGuIX has been tested in one previous study with humans. It was found that AGuIX did make tumor cells more sensitive to radiation therapy. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Participants will receive study treatment for 5 treatment days and will be followed for a year after your treatment ends. It is expected that about 100 people will take part in this research study.

Conditions

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

Interventions

Type	Name	Description
DRUG	AGuIX	Injected gadolinium-based nanoparticles
RADIATION	Radiotherapy	Stereotactic magnetic resonance-guided adaptive radiation therapy

Timeline

• Start date: 2021-05-27
• Primary completion: 2026-04-10
• Completion: 2027-09-10
• First posted: 2021-03-09
• Last updated: 2025-05-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study