← Back to Search

68Ga-DOTATATE PET/CT Scan for Neuroblastoma

Phase < 1
Recruiting
Led By Nadia Laack, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Planned for radiation planning and RT at enrolling institution
High-risk neuroblastoma requiring consolidative RT, as determined by the treating radiation oncologist
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial studies a new scan to diagnose neuroendocrine tumors in children. The new scan, 68Ga-DOTATATE PET/CT, may work better than the standard of care MIBG scan.

Who is the study for?
This trial is for children and young adults up to age 30 with certain types of neuroendocrine tumors, including neuroblastoma, that have spread. They must be fit enough for radiation therapy and not pregnant or breastfeeding unless they agree to use birth control. Participants need to consent and commit to follow-up at the enrolling institution.Check my eligibility
What is being tested?
The study tests a new scan called 68Ga-DOTATATE PET/CT in kids with metastatic neuroendocrine tumors. It checks if this radioactive tracer scan is better than current MIBG scans for diagnosis and helps target radiation treatment more effectively.See study design
What are the potential side effects?
Since the intervention involves diagnostic imaging rather than medication, side effects are minimal but may include discomfort from the injection of the radiotracer or reactions related to lying still during scanning.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for radiation therapy at the institution where I am enrolling.
Select...
My neuroblastoma is high-risk and needs additional radiation therapy.
Select...
My cancer is confirmed as neuroblastoma, ganglioneuroblastoma, or ganglioneuroma.
Select...
I am 30 years old or younger.
Select...
I can care for myself but may not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference in radiation treatment target volume definition between 68Ga-DOTATATE positron emission tomography/computed tomography (PET/CT) and iobenguane (MIBG)
Secondary outcome measures
Patterns of failure after RT
Proportion of agreement between MIBG and 68Ga-DOTATATE PET/CT in identifying neuroendocrine tumors
Tumor metabolic activity of 68Ga-DOTATATE PET/CT compared to MIBG

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort B (68Ga-DOTATATE, PET/CT)Experimental Treatment3 Interventions
Patients with previously diagnosed high-risk neuroendocrine cancer receive 68Ga-DOTATATE IV and undergo PET/CT over 20-30 minutes at the time of radiation treatment planning.
Group II: Cohort A (68Ga-DOTATATE, PET/CT)Experimental Treatment3 Interventions
Patients with newly diagnosed high-risk neuroendocrine cancer receive 68Ga-DOTATATE intravenously (IV) and undergo PET/CT over 20-30 minutes at diagnosis (before any treatment) and at the time of radiation treatment planning.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
2008
Completed Phase 2
~2260
Dotatate
FDA approved
Computed Tomography
2017
Completed Phase 2
~2790

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,327 Total Patients Enrolled
205 Trials studying Neuroblastoma
53,708 Patients Enrolled for Neuroblastoma
Mayo ClinicLead Sponsor
3,191 Previous Clinical Trials
3,758,465 Total Patients Enrolled
1 Trials studying Neuroblastoma
14 Patients Enrolled for Neuroblastoma
Nadia Laack, M.D.Principal InvestigatorMayo Clinic

Media Library

Gallium Ga 68-DOTATATE Clinical Trial Eligibility Overview. Trial Name: NCT04040088 — Phase < 1
Neuroblastoma Research Study Groups: Cohort B (68Ga-DOTATATE, PET/CT), Cohort A (68Ga-DOTATATE, PET/CT)
Neuroblastoma Clinical Trial 2023: Gallium Ga 68-DOTATATE Highlights & Side Effects. Trial Name: NCT04040088 — Phase < 1
Gallium Ga 68-DOTATATE 2023 Treatment Timeline for Medical Study. Trial Name: NCT04040088 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being admitted into this clinical trial?

"Affirmative, the clinicaltrials.gov website indicates that this trial is still enrolling volunteers. This project was first made available on September 23rd 2019 and last revised on October 11th 2022. In total, 20 individuals must be sourced from two different centres."

Answered by AI

Is there presently an opportunity for individuals to become involved in this research endeavor?

"Confirmed, the trial is still open to participants. This medical research was initially posted on September 23rd 2019 and then updated on October 11th 2022 according to clinicaltrials.gov records."

Answered by AI

Has there been prior research into the efficacy of Gallium Ga 68-DOTATATE?

"Currently, 18 trials are investigating the efficacy of Gallium Ga 68-DOTATATE with none yet in Phase 3. These studies span 51 sites, one of which is located Bethesda Maryland."

Answered by AI
~1 spots leftby Jul 2024