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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-23

Study Completion Date

2026-07-31

Brief Summary

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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.

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Detailed Description

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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 \[MIBG\]).

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 high-risk 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 high-risk 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 per standard of care for up to 2 years.

Conditions

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Ganglioneuroblastoma Ganglioneuroma Neuroblastoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cohort A (68Ga-DOTATATE, PET/CT)

Patients with newly diagnosed high-risk 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.

Group Type EXPERIMENTAL

Computed Tomography

Intervention Type PROCEDURE

Undergo PET/CT

Gallium Ga 68-DOTATATE

Intervention Type DRUG

Given IV

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET/CT

Cohort B (68Ga-DOTATATE, PET/CT)

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

Group Type EXPERIMENTAL

Computed Tomography

Intervention Type PROCEDURE

Undergo PET/CT

Gallium Ga 68-DOTATATE

Intervention Type DRUG

Given IV

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET/CT

Interventions

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Computed Tomography

Undergo PET/CT

Intervention Type PROCEDURE

Gallium Ga 68-DOTATATE

Given IV

Intervention Type DRUG

Positron Emission Tomography

Undergo PET/CT

Intervention Type PROCEDURE

Other Intervention Names

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CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized Tomography CT CT Scan tomography (68)Ga-DOTA-TATE 68Ga-DOTA-0-Tyr3-Octreotate 68Ga-DOTATATE Gallium Ga 68 Oxodotreotide Gallium Oxodotreotide Ga-68 Gallium-68 DOTA-DPhe1, Tyr3-octreotate Medical Imaging, Positron Emission Tomography PET PET Scan Positron Emission Tomography Scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging

Eligibility Criteria

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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 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 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.

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No