An Investigational Scan (68Ga-DOTATATE PET/CT) in Diagnosing Pediatric Metastatic Neuroendocrine Tumors
Study Details
Study Description
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 (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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
Detailed Description
PRIMARY OBJECTIVES:
- 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:
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To estimate the difference in metastatic tumor burden as detected by 68Ga-DOTATATE PET/CT and MIBG.
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To estimate the difference in metabolic activity between tumors diagnosed on 68Ga-DOTATATE PET/CT and MIBG.
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cohort A (68Ga-DOTATATE, PET/CT) 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. |
Procedure: Computed Tomography
Undergo PET/CT
Other Names:
Drug: Gallium Ga 68-DOTATATE
Given IV
Other Names:
Procedure: Positron Emission Tomography
Undergo PET/CT
Other Names:
|
| Experimental: Cohort B (68Ga-DOTATATE, PET/CT) 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. |
Procedure: Computed Tomography
Undergo PET/CT
Other Names:
Drug: Gallium Ga 68-DOTATATE
Given IV
Other Names:
Procedure: Positron Emission Tomography
Undergo PET/CT
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Difference in radiation treatment target volume definition between 68Ga-DOTATATE positron emission tomography/computed tomography (PET/CT) and iobenguane (MIBG) [From baseline to enrollment completion (up to 4 years)]
Will analyze the data descriptively in lieu of hypothesis testing. However, each metastatic lesion will be analyzed independently. Will report the mean and standard deviation of the difference between target tumor volumes. For patients with more than one metastasis, will compute the difference in the sum of the target volumes for all metastases.
Secondary Outcome Measures
- Proportion of agreement between MIBG and 68Ga-DOTATATE PET/CT in identifying neuroendocrine tumors [At diagnosis and up to 24 months after enrollment to follow-up]
Will calculate the proportion of metastatic tumors detected by MIBG that are also detected by 68Ga-DOTATATE PET/CT. Each metastatic lesion will be considered an independent data point. A 95% confidence interval will be included using the Clopper-Pearson method.
- Tumor metabolic activity of 68Ga-DOTATATE PET/CT compared to MIBG [At diagnosis and up to 24 months after enrollment to follow-up]
Will perform some descriptive analyses to note the differences between MIBG and 68Ga-DOTATATE PET/CT. This may include measuring the difference in the number of metastatic sites per patient. Each metastatic lesion will be considered an independent data point.
- Patterns of failure after RT [Up to 2 years]
Will evaluate patterns of failure after RT and associate with MIBG and 68Ga-DOTATATE PET/CT using two-year relapse rates. Relapse is defined as an increase in treated lesion(s) and/or new tumor per the progressive disease category of the International Neuroblastoma Response Criteria. Two-year cumulative incidence of relapse from first day of RT for the four categories listed above will be calculated considering death as a competing risk. Each relapse site will be considered an independent event.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histological confirmation of neuroblastoma, ganglioneuroblastoma, or ganglioneuroma.
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Metastatic disease requiring consolidative RT, as determined by the treating radiation oncologist.
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Eastern Cooperative Oncology Group (ECOG) performance status 0-3.
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Planned for radiation planning and RT at enrolling institution.
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Documented negative pregnancy test prior to induction chemotherapy, for women of childbearing age within =< 7 days prior to registration.
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Signed written informed consent from patient, parent, and/or legal guardian.
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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:
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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.
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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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Mayo Clinic
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Safia K Ahmed, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MC1872
- NCI-2019-04392
- MC1872
- P30CA015083