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Trial record 22 of 50 for:    DOTA- | Neuroendocrine Tumors

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

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ClinicalTrials.gov Identifier: NCT04040088
Recruitment Status : Not yet recruiting
First Posted : July 31, 2019
Last Update Posted : September 2, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

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
Ganglioneuroblastoma Ganglioneuroma Metastatic Neuroblastoma Procedure: Computed Tomography Drug: Gallium Ga 68-DOTATATE Procedure: Positron Emission Tomography Early Phase 1

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Utility of Gallium-68-DOTA-Octreotate PET/CT in the Characterization of Pediatric Neuroendocrine Tumors
Estimated Study Start Date : October 15, 2019
Estimated Primary Completion Date : July 10, 2023
Estimated Study Completion Date : July 10, 2023


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:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • computerized tomography
  • CT
  • CT SCAN
  • tomography

Drug: Gallium Ga 68-DOTATATE
Given IV
Other Names:
  • (68)Ga-DOTA-TATE
  • 68Ga-DOTATATE
  • Gallium-68 DOTA-DPhe1, Tyr3-octreotate

Procedure: Positron Emission Tomography
Undergo PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging

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:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • computerized tomography
  • CT
  • CT SCAN
  • tomography

Drug: Gallium Ga 68-DOTATATE
Given IV
Other Names:
  • (68)Ga-DOTA-TATE
  • 68Ga-DOTATATE
  • Gallium-68 DOTA-DPhe1, Tyr3-octreotate

Procedure: Positron Emission Tomography
Undergo PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging




Primary Outcome Measures :
  1. Difference in radiation treatment target volume definition between 68Ga-DOTATATE positron emission tomography/computed tomography (PET/CT) and iobenguane (MIBG) [ Time Frame: 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 :
  1. Proportion of agreement between MIBG and 68Ga-DOTATATE PET/CT in identifying neuroendocrine tumors [ Time Frame: 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.

  2. Tumor metabolic activity of 68Ga-DOTATATE PET/CT compared to MIBG [ Time Frame: 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.

  3. Patterns of failure after RT [ Time Frame: 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.



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Ages Eligible for Study:   up to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04040088


Locations
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United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Safia K. Ahmed    507-284-2511      
Principal Investigator: Safia K. Ahmed         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Safia K Ahmed Mayo Clinic

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Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT04040088     History of Changes
Other Study ID Numbers: MC1872
NCI-2019-04392 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
MC1872 ( Other Identifier: Mayo Clinic )
P30CA015083 ( U.S. NIH Grant/Contract )
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: September 2, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuroblastoma
Ganglioneuroblastoma
Ganglioneuroma