Clinical trial NCT02038738: 68Ga-DOTATATE PET Scan Imaging in Patients With Neuroendocrine Tumors
Official title: 68Ga-DOTATATE PET Scan Imaging in Patients With Neuroendocrine Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Neuroendocrine
Neuroendocrine Tumor
Neuroendocrine Cancer
Neuroendocrine Carcinoma
Carcinoid
Carcinoid Tumor
Islet Cell Tumor
Apudoma
Keywords: gallium
Ga
PET Scan
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
First posted: 2014-01-17
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Neuroendocrine cancer is an unusual disease and often goes undetected by routine imaging. The 68Ga-DOTATATE PET Scan is a novel scanning method that may have improved sensitivity and resolution specifically for neuroendocrine tumors. Patients with neuroendocrine tumors will be imaged with this agent and it will be compared to conventional imaging methods to determine the safety and efficacy of this radiopharmaceutical.


Eligibility criteria: Inclusion Criteria:

* Known diagnosis of neuroendocrine tumor or suspected SSTR positive tumors by 111In-Octreotide scan, 18FDG-PET, or MRI of the abdomen where clinically indicated
* At least 18 years of age
* Able to provide informed consent
* Karnofsky performance score greater than 50
* Females of childbearing potential must have a negative pregnancy test at screening/baseline

Exclusion Criteria:

* Serum creatinine \> 2.0 mg/dL
* Hepatic enzyme levels more than 3 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 standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
* Recognized concurrent active infection
* Previous systemic or radiation treatment for another cancer of any type within the last 2 years
* Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 5 years
Secondary outcomes:
measure: Number of lesions detected by 68Ga-DOTATATE compared to conventional imaging techniques
timeFrame: 5 years
measure: We want to determine if the 68Ga-DOTATATE PET Scan changes care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI, CT)
timeFrame: 5 years
Other outcomes:
Locations:
city: Kenner
country: United States
facility: Ochsner Medical Center - Kenner
state: Louisiana
Study officials:
References: