68Ga-DOTATATE PET Scan Imaging in Patients With Neuroendocrine Tumors

Neuroendocrine Carcinoma Clinical Trial

Official title:

68Ga-DOTATATE PET Scan Imaging in Patients With Neuroendocrine Tumors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02038738
• Other study ID #: 68Ga-DOTATATE
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: January 14, 2014
• Last updated: January 16, 2014
• Start date: March 2014

Study information

• Verified date: January 2014
• Source: Ochsner Health System
• Contact: Richard J. Campeau, M.D.
• Phone: 504-464-8500
• 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Apudoma
• Carcinoid
• Carcinoid Tumor
• Carcinoma, Neuroendocrine
• Islet Cell Tumor
• Neoplasms
• Neuroendocrine
• Neuroendocrine Cancer
• Neuroendocrine Carcinoma
• Neuroendocrine Tumor
• Neuroendocrine Tumors

Intervention

Drug:
• 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	Ochsner Medical Center - Kenner	Kenner	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Ochsner Health System

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		5 years	Yes
Secondary	Number of lesions detected by 68Ga-DOTATATE compared to conventional imaging techniques		5 years	No
Secondary	We want to determine if the 68Ga-DOTATATE PET Scan changes care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI, CT)		5 years	No