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Patients Who Receive 131 I-MIBG

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status

Withdrawn

Conditions

Brain and Nervous System

Study type

Observational

Funder types

Other

Identifiers

NCT04770831
IRB00081388
LCI-PED-NEU-MIBG-001
00047671

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

1 to 30 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Subject must meet all of the following applicable inclusion criteria to participate in this study:

  1. Written informed consent, and assent where applicable, and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
  2. Age greater than or equal to 1 years and less than or equal to 30 years at the time of therapy.
  3. Subject is scheduled to receive 131 I-MIBG therapy.
  4. Diagnosis of refractory, progressive or relapsed Neuroblastoma, Malignant Paraganglioma, Malignant Pheochromocytoma or other Neuroendocrine Tumors.
  5. 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:

  1. Prior enrollment on LCI-PED-NEU-MIBG-001 trial.

Trial design

0 participants in 1 patient group

Single Arm
Description:
QOL following MIBG

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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