Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases
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- STATUS
- Recruiting
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- End date
- Feb 27, 2026
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- participants needed
- 112
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- sponsor
- Dana-Farber Cancer Institute
Summary
The purpose of this study is to determine whether AGuIX (Activation and Guidance of Irradiation by X-ray) gadolinium-based nanoparticles make radiation work more effectively in the treatment of patients with brain metastases that are more difficult to control with stereotactic radiation alone.
Description
This research study is a double-blind, randomized phase II clinical trial of brain-directed stereotactic radiation with or without AGuIX (Activation and Guidance of Irradiation by X-ray) gadolinium-based nanoparticles in the management of brain metastases at higher-risk of local recurrence with radiation alone.
The study agent (AGuIX gadolinium-based nanoparticles) has two main parts. The first is gadolinium, also known as "contrast," which is typically injected into a vein during a MRI scan. The second part is a nanoparticle (linked to the gadolinium) that may make focused radiation work more effectively. The AGuIX gadolinium-based nanoparticles are deposited within the brain metastases via the bloodstream and then the brain metastases are radiated.
The U.S. Food and Drug Administration (FDA) has not approved AGuIX gadolinium-based nanoparticles as a treatment for any disease. AGuIX gadolinium-based nanoparticles have been tested in other studies for safety and efficacy in patients with brain metastases who are also receiving radiation.
This study seeks to determine whether AGuIX gadolinium-based nanoparticles improve outcomes relative to placebo.Participants will be "randomized" into one of the study groups:
- Group A: Radiation plus AGuIX gadolinium-based nanoparticles
- Group B: Radiation plus placebo
The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.
NH TherAguix, the manufacturer of the AGuIX gadolinium-based nanoparticles, is supporting this research study by providing the AGuIX gadolinium-based nanoparticles that will be evaluated in this study.
NH TherAguix is also covering the cost of the study.
It is expected that about 112 people will take part in this research study.
Details
| Condition | Colorectal Cancer, gastrointestinal cancer, Cyst, Neoplasm of unspecified nature of digestive system, Whole Brain Radiation, Russell-Silver syndrome, Brain Metastasis, Digestive System Neoplasms, skin cancer, her2-positive breast cancer, GASTROINTESTINAL DISORDER, octreotide scan, Noncancerous Growth, HER2 Positive Breast Cancer, Lung Cancer, her2/neu-positive breast cancer, Bronchial Neoplasm, colorectal cancers, stereotactic radiation, Breast Cancer, melanoma, gastrointestinal cancers, Malignant neoplasm of brain, cancer, colorectal, tumors, colorectal, Lung Disease, Brain Metastases, SRT, Melanoma, Brain Tumor (Pediatric), Metastatic Melanoma, Malignant Melanoma, Breast Cancer Diagnosis, colorectal tumor, Gastrointestinal Neoplasm, colorectal neoplasm, breast carcinoma, Pulmonary Disease, Brain Tumor, Lung Neoplasm, Rectal disorder, Gastrointestinal Diseases and Disorders, nanoparticle, cancer, breast, Brain Cancer, Colon Cancer Screening, carcinoma lung, Colon cancer; rectal cancer, Rectal Disorders, Skin Cancer, somatostatin receptor scintigraphy, brain tumors, malignant brain tumor, lung carcinoma, aguix-np |
|---|---|
| Treatment | Placebo, Stereotactic Radiation, AGuIX gadolinium-based nanoparticles |
| Clinical Study Identifier | NCT04899908 |
| Sponsor | Dana-Farber Cancer Institute |
| Last Modified on | 27 October 2021 |
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