Brain and Nervous SystemNCT04770831
Patients Who Receive 131 I-MIBG
An observational study of Brain and Nervous System, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 30 years
- Conditions the study is for
- Brain and Nervous System
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2021to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Subject must meet all of the following applicable inclusion criteria to participate in this study:
- 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.
Who cannot join
- Subjects meeting the criteria below may not participate in the study:
- 1. Prior enrollment on LCI-PED-NEU-MIBG-001 trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Levine Cancer Institute
Charlotte, North Carolina, 28204
About this study
Official title: An Observational Study of Patients With Recurrent Progressive or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma Who Receive 131 I- MIBG
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.
Read the detailed 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.
- Conditions
- Brain and Nervous System
- Medical subject headings
- Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | QOL following MIBG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: For up to 2 years after treatment with 131 I-MIBG
Secondary outcomes (2)
Progression Free Survival (PFS)
To assess progression free survival (PFS) to 131I-MIBG therapy for subjects with refractory, relapsed or progressive neuroblastoma, malignant pheochromocytoma or paraganglioma, or other neuroendocrine tumors.
Measured: From on study date to date of progression or death, for up to 5 years
Disease Control Rate
To evaluate disease control rate to 131I-MIBG treatment in subjects with refractory, relapsed or progressive neuroblastoma or other neuroendocrine tumors (not limited to but including malignant pheochromocytoma or paraganglioma).
Measured: From on study date to off study date, for up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start10 Mar 2021
- Primary completionDec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Why it stopped: difficult enrollment, no subjects consented or enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Nervous SystemStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javier Oesterheld, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770831
- Sponsor's protocol ID
- IRB00081388
- Other IDs
- 00047671, LCI-PED-NEU-MIBG-001
- Status last verified
- Dec 2022
- First submitted
- 16 Feb 2021
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Patients With Recurrent Progressive or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma Who Receive 131 I- MIBG
- ClinicalTrials.gov ID
- NCT04770831
- Acronym / sponsor ID
- IRB00081388
- Conditions
- Brain and Nervous System
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: difficult enrollment, no subjects consented or enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | – | –QOL following MIBG |
Who may qualify
- Ages
- 1 year to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (6 listed)
- Subject must meet all of the following applicable inclusion criteria to participate in this study:
- 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.
Key exclusion criteria (2 listed)
- 1. Prior enrollment on LCI-PED-NEU-MIBG-001 trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Quality of Life
Time frame: For up to 2 years after treatment with 131 I-MIBG
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.
2 secondary outcomes
Progression Free Survival (PFS)
Time frame: From on study date to date of progression or death, for up to 5 years
Disease Control Rate
Time frame: From on study date to off study date, for up to 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Oesterheld, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain and Nervous System, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life (time frame: For up to 2 years after treatment with 131 I-MIBG). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.