Evaluating AGuIX® Nanoparticles in Combination With Stereotactic Radiation for Brain Metastases (NANOSTEREO)
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|ClinicalTrials.gov Identifier: NCT04094077|
Recruitment Status : Active, not recruiting
First Posted : September 18, 2019
Last Update Posted : November 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Brain Metastases||Drug: AGuIX||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||This study is a paucicentric, single arm Phase II trial conducted according to a single stage Fleming-A'Hern design and aiming to evaluate the efficacy of AGuIX® during FSRT of brain metastasis.|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Evaluating AGuIX® Nanoparticles in Combination With Stereotactic Radiation for Oligo Brain Metastases.|
|Actual Study Start Date :||January 17, 2020|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2022|
|Experimental: Aguix + Stereotactic Radiation||
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.
- Rate of local control [ Time Frame: 1 year ]The primary endpoint is the rate of local control defined as the proportion of patients with a complete response, a partial response or a stable disease. Response of Brain lesion will be evaluated using the RECIST classifications with partial response (PR, > 30% decrease in longest diameter), stable disease (SD <30% decrease and <20% increase in longest diameter), progressive disease (PD > 20% increase in longest diameter) and Complete response (CR) (complete disappearance of the brain lesion).
- Distant Brain failure [ Time Frame: 6 month and at 1 year ]Distant Brain failure is defined as the presence of new brain metastases or leptomeningeal enhancement outside the irradiated volume.
- Time to brain relapse [ Time Frame: 6 month and 1 year ]The event of interest will be the local progression on any irradiated lesion.
- Tumor target volume [ Time Frame: 4 days ]The Tumor target volume agreement is the comparison between both the MRI images with AGuIX® and Gd-chelates. It is defined as the correlation between the irradiation volume calculated based on the MRI before nanoparticles injection and the volume calculated after nanoparticles injection.
- Brain lesion 3-D volume variation [ Time Frame: 45 days and 3 month ]Brain lesion 3-D volume variation will be analysed using volumetric T1 post-gadolinium MRI.
- Adverse events [ Time Frame: From Day 1 to Day 45 ]The assessment of safety will be based mainly on the frequency of adverse events based on the common toxicity criteria (CTCAE-V5.0) grade.
- FACT-Br [ Time Frame: 45 days, 3 month, 6 month, 9 month and 12 month ]The FACT-Br consists of a general version (FACT-G) and a brain subscale (BRCS). The FACT-G consist of 27 questions with 4 domains assessing physical well-being (score range: 0-28), social/family well-being (score range: 0-28), emotional well-being (score range: 0-24) and functional well-being (score range: 0-28). The BRCs is a 23-item questionnaire related to neurological concerns that provides an additional set of disease-specific questions pertaining to brain neoplasms (score range: 0-92). The FACT-Br total score is the sum of the FACT-G total score and the BrCS score. Positive change scores indicate improved quality of life.
- MMSE [ Time Frame: 45 days, 3 month, 6 month, 9 month and 12 month ]The MMSE is an 11-item measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall and language. The minimum score is 0 and the maximum score is 30 with higher MMSE scores indicating better cognition.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04094077
|Centre Léon Bérard|
|Lyon, France, 69008|
|Centre Antoine Lacassagne|
|Nice, France, 06189|