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Radiotherapy of Multiple Brain Metastases Using AGuIX®

NCT03818386 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-06-14

No results posted yet for this study

Summary

This is a Prospective Randomized Open Blinded Endpoint phase II clinical trial. The study will be adaptive: an interim analysis is planned after enrolment of 20 patients in each arm of treatment (WBRT and AGuIX® + WBRT), to select and continue the study with group(s) that present the best response rate to the experimental treatment (AGuIX® + WBRT).

The main endpoint will be evaluated by a blinded endpoint committee.

Conditions

  • Brain Metastases, Adult
  • Radiotherapy

Interventions

DRUG

AGuIX®

3 intravenous injection at 100mg/kg * D0: AGuIX® injection followed by MRI (within 7 days before commencement of WBRT) * Fr1: AGuIX® injection before the first radiation session * Fr6: AGuIX® injection before the sixth radiation session

RADIATION

Whole Brain Radiation Therapy

30 Gy in 10 fractions of 3 Gy over 2-3 weeks

Sponsors & Collaborators

  • NH TherAguix SAS

    collaborator OTHER

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Camille VERRY, MD · University Hospital, Grenoble

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-26
Primary Completion
2024-06-26
Completion
2025-03-26

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03818386 on ClinicalTrials.gov