Status:
ACTIVE_NOT_RECRUITING
An Investigational Scan (68Ga-DOTATATE PET/CT) in Diagnosing Pediatric Metastatic Neuroendocrine Tumors
Lead Sponsor:
Mayo Clinic
Conditions:
Ganglioneuroblastoma
Ganglioneuroma
Eligibility:
All Genders
Up to 30 years
Phase:
EARLY_PHASE1
Brief Summary
This trial studies how well an investigational scan called 68Ga-DOTATATE PET/CT works in diagnosing pediatric patients with neuroendocrine tumors that have spread to other places in the body (metastat...
Detailed Description
PRIMARY OBJECTIVE: I. To estimate the difference in radiation therapy (RT) target volume definition between gallium Ga 68-DOTATATE (68Ga-DOTATATE) PET/CT and iobenguane (metaiodobenzylguanidine \[MIB...
Eligibility Criteria
Inclusion
- Age =\< 30 years
- Histological confirmation of neuroblastoma, ganglioneuroblastoma, or ganglioneuroma.
- High-risk neuroblastoma requiring consolidative RT, as determined by the treating radiation oncologist.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-3 (patients 16 years old or older at entry) or Lansky Score of 30-100 (patients \<16 years old at entry).
- Planned for radiation planning and RT at enrolling institution.
- Documented negative pregnancy test prior to induction chemotherapy, for women of childbearing age within =\< 7 days prior to registration.
- Willing to return to enrolling institution for follow-up imaging and clinical evaluation, or willing to send follow-up imaging and clinical notes to enrolling institution (during the observation phase of the study).
Exclusion
- Pregnant women, nursing women who refuse to stop breastfeeding, or men/women of childbearing age who are unwilling to use an effective birth control method.
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
- Immunocompromised patients and patients known to be human immunodeficiency virus positive and currently receiving antiretroviral therapy. NOTE: Patients known to be human immunodeficiency virus positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
Key Trial Info
Start Date :
September 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04040088
Start Date
September 23 2019
End Date
July 1 2026
Last Update
January 8 2026
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905