68Ga DOTA-TATE PET/CT In Somatostatin Receptor Positive Tumors

Study Overview

68Ga DOTA-TATE PET/CT in Somatostatin Receptor Positive Tumors

The primary objective of the study is to evaluate 68Ga-DOTA TATE PET/CT for staging and monitoring response to chemotherapy in patients with carcinoid, neuroendocrine tumors, medullary thyroid cancer and other cancers expressing somatostatin receptors.

N/A

Carcinoid Tumors
Islet Cell (Pancreatic NET)
Other Neuroendocrine Tumors

DRUG: 68Ga-DOTA TATE

NET0017
26988

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2013-11-04	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2017-08-21
First Submitted that Met QC Criteria 2013-11-08	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2017-08-23
First Posted (ACTUAL) 2013-11-11	Results First Posted N/A	Last Verified 2017-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Greater than 18 years-old at the time of radiotracer administration
Provides written informed consent
Known diagnosis of NET or suspected SSTR positive tumors by 111In-Octreotide scan, 18FDG-PET, or MRI of the abdomen when clinically indicated
Karnofsky score greater than 50 or ECOG Performance Status 0-2
Women of childbearing age must have a negative pregnancy test at screening/baseline
Able to remain still for duration of each imaging procedure (about one hour)

Less than 18 years-old at the time of radiotracer administration
Pregnant or nursing
Serum creatinine >3.0 mg/dL
Hepatic enzyme levels more than 5 times upper limit of normal.
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.
Inability to lie still for the entire imaging time
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Andrei Iagaru, Stanford University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record