Trials / Terminated
TerminatedNCT04094077
Evaluating AGuIX® Nanoparticles in Combination With Stereotactic Radiation for Brain Metastases
A Phase II Study Evaluating AGuIX® Nanoparticles in Combination With Stereotactic Radiation for Oligo Brain Metastases.
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Centre Leon Berard · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study evaluates the clinical impact of AGuIX® nanoparticles in combination with Fractionated Stereotactic Radiation in oligo brain metastases.
Detailed description
AGuIX® (Activation and Guidance of Irradiation by X-ray, NH TherAguix) are Gadolinium chelated polysiloxane based nanoparticles with Magnetic Resonance contrast properties, able to accumulate in the tumor through the enhanced permeability and retention effect and sufficiently small (sub-5 nm diameter) to allow for renal clearance. AGuIX® nanomedicine can be used as: * Positive contrast agent for Magnetic Resonance Imaging (MRI). It displays higher efficacy than commercial contrast agents and so it can be used to delineate precisely the tumors. * A booster of Radiotherapy during the radiotherapy protocol, after the localization of the tumor. This is permitted by the high radiosensitizing potential of AGuIX® that allows a local increase of efficacy of X-ray damages. French and international groups have demonstrated the radiosensitizer effect of AGuIX® to improve the efficacy of radiotherapy. Thanks to a difference in porosity between the vascular networks, AGuIX® penetrates and resides in tumor tissues, but not in healthy tissues.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AGuIX | 2 IV injections (100 mg/Kg/injection) at day 4 and day 8 + Strereotactic Radiation from day 8 to day 15 as per standard practice. |
Timeline
- Start date
- 2020-01-17
- Primary completion
- 2021-02-24
- Completion
- 2021-02-24
- First posted
- 2019-09-18
- Last updated
- 2021-06-08
Locations
2 sites across 1 country: France
Source: ClinicalTrials.gov record NCT04094077. Inclusion in this directory is not an endorsement.