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68Ga-DOTATATE PET/CT Scan for Neuroblastoma

Phase < 1

Recruiting

Led By Nadia Laack, MD

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

Histological confirmation of neuroblastoma, ganglioneuroblastoma, or ganglioneuroma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

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.

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.

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

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I am scheduled for radiation therapy at the institution where I am enrolling.

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My cancer is confirmed as neuroblastoma, ganglioneuroblastoma, or ganglioneuroma.

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I am 30 years old or younger.

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I can care for myself but may not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Difference in radiation treatment target volume definition between 68Ga-DOTATATE positron emission tomography/computed tomography (PET/CT) and iobenguane (MIBG)

Secondary study objectives

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2011

Completed Phase 2

~2200

Computed Tomography

2017

Completed Phase 2

~2790