Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors
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|ClinicalTrials.gov Identifier: NCT02441062|
Recruitment Status : Suspended (Temporary hold enrollment review)
First Posted : May 12, 2015
Last Update Posted : August 13, 2019
Participants in this study have been diagnosed with a tumor such as a carcinoid, neuroendocrine tumor, neuroblastoma, Ewing's sarcoma, or brain tumor that has cells which carry somatostatin receptors.
The purpose of this research study is to see if the tumor can be identified using a special procedure called a positron emission tomography (PET) scan and how the results of this imaging procedure will change the management of the tumor.
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors Carcinoid Tumors Neuroblastoma Medulloblastoma||Drug: 68Ga-DOTATOC PET/CT||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Ga-68 DOTATOC PET-CT Imaging in Management of Neuroendocrine Tumors|
|Actual Study Start Date :||September 2015|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||June 2021|
Study participants will receive 68Ga-DOTATOC and undergo a PET/CT imaging study. Subjects may receive a second 68Ga-DOTATOC PET/CT for restaging after therapy 12-36 months following the first scan.
Drug: 68Ga-DOTATOC PET/CT
Ga-68 DOTATOC PET-CT on management of patients with somatostatin receptor positive tumors
- Evaluate impact of 68Gallium-DOTATOC PET/CT imaging on tumor management [ Time Frame: 36 months ]Referring physicians will be asked to fill out pre-PET and post-PET scan forms to provide information on the management and treatment strategy of the patient before the PET-CT scan and after the information from the PET-CT study is available. This is the same methodology used in the National Oncologic PET Registry study; change in management strategy criteria are modified for the specific treatment strategies used in NET (Table 2).
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): NCT02441062
|United States, Iowa|
|University of Iowa Hospitals and Clinics|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Mary S O'Dorisio, MD, PhD||University of Iowa|