Patients Who Receive 131 I-MIBG

NCT04770831 | Withdrawn DMC

• 3 other identifiers: IRB0008138800047671LCI-PED-NEU-MIBG-001
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Brain and Nervous System

Outcome Measures

Primary Outcomes (1)

• Change in Quality of Life

  To assess health related quality of life prior to, during and after therapy with 131 I-MIBG. For subject's ≥8 years of age, their patient reported Peds QL will be compared to their caregiver's perspective.

  For up to 2 years after treatment with 131 I-MIBG

Secondary Outcomes (2)

• Progression Free Survival (PFS)

  From on study date to date of progression or death, for up to 5 years

• Disease Control Rate

  From on study date to off study date, for up to 5 years

Study Arms (1)

Single Arm

QOL following MIBG

Eligibility Criteria

• Age: 1 Year - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with refractory, relapsed or progressive neuroblastoma, malignant pheochromocytoma or paraganglioma, or other neuroendocrine tumors will be recruited at Levine Cancer Institute (LCI), Torrence E. Hemby Jr. Pediatric Hematology \& Oncology Center, or Atrium Health Levine Children's Hospital.

You may qualify if:

• 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.
• Age greater than or equal to 1 years and less than or equal to 30 years at the time of therapy.
• Subject is scheduled to receive 131 I-MIBG 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.

You may not qualify if:

• Subjects meeting the criteria below may not participate in the study:
• \. Prior enrollment on LCI-PED-NEU-MIBG-001 trial.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Neurologic Manifestations

Condition Hierarchy (Ancestors)

Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Javier Oesterheld, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 25, 2021
• Study Start: March 10, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: December 14, 2022

Record last verified: 2022-12

Locations

US (1)