- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02038738
68Ga-DOTATATE PET Scan Imaging in Patients With Neuroendocrine Tumors
January 16, 2014 updated by: Richard J. Campeau, M.D., FACNM, Ochsner Health System
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.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
250
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Richard J. Campeau, M.D.
- Phone Number: 504-464-8500
Study Locations
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Louisiana
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Kenner, Louisiana, United States, 70065
- Ochsner Medical Center - Kenner
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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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Scan
We will perform 68Ga-DOTATATE PET scans on subjects.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of lesions detected by 68Ga-DOTATATE compared to conventional imaging techniques
Time Frame: 5 years
|
5 years
|
We want to determine if the 68Ga-DOTATATE PET Scan changes care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI, CT)
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 Major Dates
Study Start
March 1, 2014
Primary Completion (ANTICIPATED)
March 1, 2019
Study Registration Dates
First Submitted
January 14, 2014
First Submitted That Met QC Criteria
January 16, 2014
First Posted (ESTIMATE)
January 17, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
January 17, 2014
Last Update Submitted That Met QC Criteria
January 16, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Pancreatic Diseases
- Adenoma
- Pancreatic Neoplasms
- Neoplasms
- Carcinoma, Neuroendocrine
- Neuroendocrine Tumors
- Carcinoid Tumor
- Adenoma, Islet Cell
- Apudoma
Other Study ID Numbers
- 68Ga-DOTATATE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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