Utility of Gallium-68-DOTA-Octreotat PET/CT in the Characterization of Pediatric Neuroendocrine Tumors

Overview

About this study

The purpose of this pilot study is to assess the efficacy of the Federal Drug Administration approved 68Ga-DOTATATE PET/CT in the radiotherapeutic target volume definition of metastatic neuroendocrine tumors as compared to MIBG scintigraphy. Secondary

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • 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 y.o. or older at entry) or Lansky Score of 30-100 (patients < 16 y.o. 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.
  • Signed written informed consent from patient, parent, and/or legal guardian.
  • 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 Criteria:

  • 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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 1/25/24. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Nadia Laack, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Adam Amundson

(507) 293-1826

Amundson.Adam1@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20463890

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