68Ga-DOTATATE PET Scan in Neuroendocrine Cancer

Study Overview
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Brief Summary
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Neuroendocrine cancer is an unusual disease and often goes undetected by routine imaging. The 68Ga-DOTATATE PET scan is a new generation of scans that might have improved sensitivity and resolution specifically for neuroendocrine tumors. The investigators will scan people with this cancer and compare it to other conventional imaging methods to see if it improves patient care.

Detailed Description
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Eligible participants will undergo baseline assessments at enrollment. Study participants will receive a one-time administration of 68GaDOTATATE and undergo a PET/CT imaging study. Scans will be performed with negative oral contrast (e.g. Volumen™ or equivalent), as many NETs involve the GI tract.

Official Title
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Use of 68Ga-DOTATATE PET Scanning for Diagnosis and Treatment of Metastatic Neuroendocrine Tumors

Conditions
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Neuroendocrine Carcinoma

Intervention / Treatment
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* Radiation: 68Ga-DOTATATE PET scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Known diagnosis of neuroendocrine tumor At least 18 years of age Able to provide informed consent Karnofsky score greater than 50 Females of childbearing potential must have a negative pregnancy test at screening/baseline Exclusion Criteria: Serum creatinine >3.0 mg/dL (270 μM/L) Hepatic enzyme levels more than 5 times upper limit of normal. Known severe allergy or hypersensitivity to IV radiographic contrast. Use of any other investigational product or device within 30 days prior to dosing, or known requirement for any other investigational agent prior to completion of all scheduled study assessments. Patients with a body weight of 400 pounds or more or not able to enter the bore of the PET/CT scanner due to BMI, because of the compromise in image quality with CT, PET/CT and MRI that will result. Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.). Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.) Recognized concurrent active infection Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-DOTATATE PET<br>Patients will receive a 68Ga-DOTATATE PET scans | Radiation: 68Ga-DOTATATE PET scan<br>* 68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography (PET). Efficacy of the 68Ga-DOTATATE PET scan was assessed and compared to 111In-Pentetreotide scan and to scans with CT and/or MRI. Safety and toxicity were also assessed with pre-injection and post-imaging vital signs, pulse oximetry on room air, 12 lead ECGs, and blood laboratory tests, including tumor markers, liver and renal functions and blood counts, and direct patient questioning. Late delayed tumor markers, liver and renal functions and blood counts were assessed when available.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients That Experienced a Change in Care Plans After 68GA-DOTATATE PET Scan | Determine if the 68Ga-DOTATATE PET scan changes patient care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI, CT, U/S). | at 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Severe Adverse Events Occurences Resulting in Changes to Patient Treatment Plans, as a Measure of Safety and Tolerability | Determine if any adverse effects are associated with the 68Ga-DOTATATE PET scan and the number of patients that experience them using NCI Common Terminology Criteria for Adverse Events v4.0, where: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening; Grade 5, death. Toxicities present at baseline and continuing without change in grade were excluded for assessment of this outcome measure. | at 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuroendocrine, neuroendocrine carcinoma, neuroendocrine tumor, carcinoid, carcinoid tumor, islet cell tumor, APUDoma, Gallium, PET Scan