68Ga-DOTATATE PET Scan in Neuroendocrine Cancer

Neuroendocrine Carcinoma Clinical Trial

— 68Ga  

Official title:

68Ga-DOTATATE PET Scanning for Diagnosis and Treatment of Neuroendocrine Tumors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01396382
• Other study ID #: 110588
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: July 11, 2011
• Last updated: December 16, 2013
• Start date: August 2011
• Est. completion date: March 2014

Study information

• Verified date: December 2013
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 99
• Est. completion date: March 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoid Tumor
• Carcinoma, Neuroendocrine
• Neuroendocrine Carcinoma
• Neuroendocrine Tumors

Intervention

Drug:
• 68Ga-DOTATATE PET scan
68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Determine if any adverse effects are associated with the scan and the number of patients that experience them.	One year	Yes
Secondary	Number of lesions detected by 68GA-DOTATATE compared to conventional imaging techniques	We want to determine if the 68Ga-DOTATATE PET scan changes care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI, CT, U/S).	one year	No