Evaluation of FDOPA-PET/MRI in Pediatric Patients With CNS Tumors

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT01999270
Phase
PHASE1
Status
Completed

Conditions

  • Astrocytoma, Oligoastrocytoma, Mixed
  • Ganglioglioma
  • Ganglioneuroma
  • Glioblastoma Multiforme Glioma
  • Glioma

Eligibility Criteria

Sex
ALL
Age
N/A - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan — DRUG
    Irinotecan IV over 90 minutes on Days 1, 15, and 29 of each cycle (except Cycle 1, when it will be started on Day 29) Note: Irinotecan can be removed from the treatment plan at the discretion of the healthcare provider.
  • Bevacizumab — DRUG
    Bevacizumab will be given intravenously AFTER the irinotecan infusion is complete on Days 1, 15, and 29 of each cycle. The first dose will be given over 90 minutes, but doses after that may be given over 30-60 minutes.
  • FDOPA-PET/MRI imaging — DEVICE
    FDOPA-PET/MRI imaging Baseline (before beginning Cycle 1 treatment) Cycle 1, Day 29 (before receiving your treatment with bevacizumab) and end of treatment or time of relapse

Study Details

To determine if FDOPA-PET/MRI imaging can predict response to treatment of bevacizumab.

Key Dates

Start date
Apr 30, 2013
Status verified
Oct 2016
Primary completion
May 31, 2016
Completion
May 31, 2016

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Irinotecan, Bevacizumab and FDOPA-PET/MRI imaging
    Irinotecan can be removed from the treatment plan at the discretion of the healthcare provider.

Primary Outcome Measure

FDOPA-PET/MRI imaging [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-

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By specialty
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By research site
Washington University School of Medicine· St Louis, MO

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