Patients Who Receive 131 I-MIBG

  • STATUS
    Recruiting
  • End date
    Dec 1, 2024
  • participants needed
    15
  • sponsor
    Wake Forest University Health Sciences
Updated on 27 May 2022

Summary

This study is for patients who have have neuroblastoma, pheochromocytoma, or paraganglioma that has come back (relapsed) after treatment or has not gotten better (refractory) with standard treatment. The purpose of this study is to evaluate quality of life and response rate to 131 I-MIBG treatment.

Description

This is an observational, single institution study designed to determine the benefit of 131I-MIBG therapy in subjects with refractory, relapsed or progressive neuroblastoma, malignant pheochromocytoma or paraganglioma, or other neuroendocrine tumors. Response rate, time to progression, and quality of life changes will be evaluated.

Details
Condition Brain and Nervous System
Clinical Study IdentifierNCT04770831
SponsorWake Forest University Health Sciences
Last Modified on27 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject must meet all of the following applicable inclusion criteria to participate in this
Written informed consent, and assent where applicable, and HIPAA authorization for
study
release of personal health information. NOTE: HIPAA authorization may be included in
the informed consent or obtained separately
Subject is scheduled to receive 131 I-MIBG therapy
Age greater than or equal to 1 years and less than or equal to 30 years at the time of
therapy
Diagnosis of refractory, progressive or relapsed Neuroblastoma, Malignant
Paraganglioma, Malignant Pheochromocytoma or other Neuroendocrine Tumors
As determined by the enrolling physician, ability of the subject and parent/caregiver
to understand and comply with study procedures for the entire length of the study

Exclusion Criteria

Subjects meeting the criteria below may not participate in the study
Prior enrollment on LCI-PED-NEU-MIBG-001 trial
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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