68Ga-DOTATATE PET Scan in Neuroendocrine Cancer

Phase 2

Completed

• Conditions: Neuroendocrine Carcinoma
• Interventions: Radiation: 68Ga-DOTATATE PET scan

• Registration Number: NCT01396382
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2011-07-11
• Study First Submitted QC: 2011-07-14
• Study First Posted: 2011-07-18
• Primary Completion: 2014-05
• Study Completion: 2014-12
• Results First Submitted: 2016-01-14
• Status Verified: 2016-02
• Results First Submitted QC: 2016-02-25
• Last Update Submitted: 2016-02-25
• Results First Posted: 2016-03-29
• Last Update Posted: 2016-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 97

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-DOTATATE PET	68Ga-DOTATATE PET scan	Patients will receive a 68Ga-DOTATATE PET scans

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Severe Adverse Events Occurences Resulting in Changes to Patient Treatment Plans, as a Measure of Safety and Tolerability	at 1 year	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.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States