An Investigational Scan (68Ga-DOTATATE PET/CT) in Diagnosing Pediatric Metastatic Neuroendocrine Tumors

  • STATUS
    Recruiting
  • End date
    Jul 10, 2023
  • participants needed
    20
  • sponsor
    Mayo Clinic
Updated on 27 June 2021
ganglioneuroblastoma
68ga-dotatoc

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 (metastatic). A neuroendocrine tumor is an abnormal growth of neuroendocrine cells, which are cells resembling nerve cells and hormone-producing cells. 68Ga-DOTATATE is a radioactive substance called a radiotracer that when used with PET/CT scans, may work better than standard of care MIBG scans in diagnosing pediatric metastatic neuroendocrine tumors and targeting them with radiation therapy.

Description

PRIMARY OBJECTIVES:

I. To estimate the difference in radiation therapy (RT) target volume definition between gallium Ga 68-DOTATATE (68Ga-DOTATATE) PET/CT and iobenguane (metaiodobenzylguanidine [MIBG]).

SECONDARY OBJECTIVES:

I. To estimate the difference in metastatic tumor burden as detected by 68Ga-DOTATATE PET/CT and MIBG.

II. To estimate the difference in metabolic activity between tumors diagnosed on 68Ga-DOTATATE PET/CT and MIBG.

III. To evaluate patterns of failure after RT in association with 68Ga-DOTATATE PET/CT and MIBG.

OUTLINE: Patients are assigned to 1 of 2 cohorts.

COHORT A: Patients with newly diagnosed 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.

COHORT B: Patients with previously diagnosed with neuroendocrine cancer receive 68Ga-DOTATATE IV and undergo PET/CT over 20-30 minutes at the time of radiation treatment planning.

After completion of study, patients are followed up every 3 months for up to 2 years.

Details
Condition Ganglioneuroma, Ganglioneuroblastoma, Metastatic Neuroblastoma, Neuroblastoma
Treatment computed tomography, positron emission tomography, Gallium Ga 68-DOTATATE
Clinical Study IdentifierNCT04040088
SponsorMayo Clinic
Last Modified on27 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histological confirmation of neuroblastoma, ganglioneuroblastoma, or ganglioneuroma
Metastatic disease requiring consolidative RT, as determined by the treating radiation oncologist
Eastern Cooperative Oncology Group (ECOG) performance status 0-3
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
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