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

• Status: Recruiting
• Trial end date: 2023-07-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)
• Treatments: 1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid

Criteria

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.