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Imaging of Intravenous (IV) Combidex to Brain, Intra-cerebral Tumors and in Central Nervous System (CNS) Inflammation

NCT ID: NCT00659334

Last Updated: 2022-12-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-08-31

Study Completion Date

2010-03-31

Brief Summary

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Combidex (ferumoxtran-10) is an ultra-small iron oxide particle covered with a sugar coating. It has been evaluated as an MRI contrast agent for use in imaging well perfused organs such as the liver and spleen and for imaging lymph nodes. In this study, Combidex is being used to compare the standard imaging agent, Gadolinium, in imaging brain tumors and the area adjacent to the tumor location. Combidex may provide the ability to better see brain tumors and inflammatory lesions on magnetic resonance imaging (MRI) scans. Combidex may be useful in its ability to cross blood vessels into brain tumors, and because of its size and ability to get into the area next to brain tumors, could assist in the treatment of brain tumors with other drugs in the future.

Detailed Description

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Subjects are recruited as patients in one of the neurology, neurosurgery or neuro-oncology clinics at OHSU. There are four groups of the study:

* Subjects receive the combidex infusion only.
* Subjects receive Combidex and undergo a previously schedule neurosurgery.
* Subjects undergo surgery only and provide a sample of their tumor tissue to be used in pathology studies of Combidex.
* Subjects with MS or stroke are invited to participate in receiving Combidex to evaluate the effectiveness of enhancing the area of damage within the brain.

Subjects are deemed eligible for the study and undergo a baseline MRI within 28 days of receiving Combidex. Subjects receiving Combidex are admitted for a half day into the Oregon Clinical \& Translational Research Institute(OCTRI). Combidex is infused I.V. over 30 minutes. Subjects are monitored for side effects and are discharged within about 5 hours after the infusion, if no complications have been noted. Subjects return 24 hours after the infusion for a post infusion MRI scan and return again to one of the neurology clinics for one month follow-up. Subjects enrolled in group 2 undergo surgery 1-2 days after the Combidex infusion and also undergo a 24 post infusion MRI and return for one month follow-up. These subjects are also followed closely by the neurosurgical physician during the course of follow-up. Subjects enrolled in group 3 only undergo surgery and agree to have a piece of their tumor resection or biopsy donated for use in the study. Group 4 is the same as group 1, except the patient population includes multiple sclerosis and stroke instead of patients with brain tumors.

Conditions

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Brain Neoplasms

Keywords

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Combidex Diagnostic imaging

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Adults with brain tumor to receive Combidex infusion only

Group Type ACTIVE_COMPARATOR

Ferumoxtran-10 (Combidex)

Intervention Type DRUG

2.6 mg/kg

2

Adults with brain tumors to receive Combidex infusion and neurosurgery

Group Type ACTIVE_COMPARATOR

Ferumoxtran-10 (Combidex)

Intervention Type DRUG

2.6 mg/kg

Neurosurgery

Intervention Type PROCEDURE

neuro-surgical tumor biopsy or resection to assess particle localization. Biopsy (stereotactic, when possible) will take place following the 24 hour post- Combidex MR and within 48 hrs of i.v. Combidex administration. Biopsies will be taken from the tumor, brain around tumor (BAT) and brain distant to tumor and the MR localization and histology will be compared. The tissue will be obtained by either resection or needle frameless stereotactic biopsy.

3

Adults with brain tumors to receive neurosurgery only (NO Combidex)

Group Type OTHER

Neurosurgery

Intervention Type PROCEDURE

neuro-surgical tumor biopsy or resection to assess particle localization. Biopsy (stereotactic, when possible) will take place following the 24 hour post- Combidex MR and within 48 hrs of i.v. Combidex administration. Biopsies will be taken from the tumor, brain around tumor (BAT) and brain distant to tumor and the MR localization and histology will be compared. The tissue will be obtained by either resection or needle frameless stereotactic biopsy.

4

Children with brain tumors to receive Combidex only

Group Type ACTIVE_COMPARATOR

Ferumoxtran-10 (Combidex)

Intervention Type DRUG

2.6 mg/kg

5

Children with brain tumors to receive Combidex and neurosurgery

Group Type ACTIVE_COMPARATOR

Ferumoxtran-10 (Combidex)

Intervention Type DRUG

2.6 mg/kg

Neurosurgery

Intervention Type PROCEDURE

neuro-surgical tumor biopsy or resection to assess particle localization. Biopsy (stereotactic, when possible) will take place following the 24 hour post- Combidex MR and within 48 hrs of i.v. Combidex administration. Biopsies will be taken from the tumor, brain around tumor (BAT) and brain distant to tumor and the MR localization and histology will be compared. The tissue will be obtained by either resection or needle frameless stereotactic biopsy.

6

Children with brain tumors to receive neurosurgery only, NO Combidex

Group Type OTHER

Neurosurgery

Intervention Type PROCEDURE

neuro-surgical tumor biopsy or resection to assess particle localization. Biopsy (stereotactic, when possible) will take place following the 24 hour post- Combidex MR and within 48 hrs of i.v. Combidex administration. Biopsies will be taken from the tumor, brain around tumor (BAT) and brain distant to tumor and the MR localization and histology will be compared. The tissue will be obtained by either resection or needle frameless stereotactic biopsy.

7

Adults with Inflammatory lesions (stroke or MS) to receive Combidex only

Group Type ACTIVE_COMPARATOR

Ferumoxtran-10 (Combidex)

Intervention Type DRUG

2.6 mg/kg

Interventions

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Ferumoxtran-10 (Combidex)

2.6 mg/kg

Intervention Type DRUG

Neurosurgery

neuro-surgical tumor biopsy or resection to assess particle localization. Biopsy (stereotactic, when possible) will take place following the 24 hour post- Combidex MR and within 48 hrs of i.v. Combidex administration. Biopsies will be taken from the tumor, brain around tumor (BAT) and brain distant to tumor and the MR localization and histology will be compared. The tissue will be obtained by either resection or needle frameless stereotactic biopsy.

Intervention Type PROCEDURE

Other Intervention Names

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Combidex

Eligibility Criteria

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Inclusion Criteria

* Brain tumor or CNS inflammatory lesion including stroke or MS
* 5 yrs old or older
* Able to undergo MRI without general anesthesia
* Agree to be followed for 1 month following infusion of Combidex
* Sign a written informed consent
* If female and of child-bearing potential, be postmenopausal, sterile, or be on birth control for 1 month prior to study
* Must have a pre-treatment MRI within 28 days before study

Exclusion Criteria

* Clinically significant signs of uncal herniation
* Allergy to study drug, Combidex
* Hepatic insufficiency
* Stage IV or V renal insufficiency
* If female, pregnant or lactating
* Require anesthesia for MRI scanning
* Hemachromatosis
Minimum Eligible Age

5 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Edward Neuwelt

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Edward A Neuwelt, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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5R01NS034608

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OHSU-1127

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00001127

Identifier Type: -

Identifier Source: org_study_id