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

This study is not yet open for participant recruitment.
Verified January 2014 by Richard J. Campeau, M.D., FACNM, Ochsner Health System
Sponsor:
ClinicalTrials.gov Identifier:
NCT02038738
First Posted: January 17, 2014
Last Update Posted: January 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Richard J. Campeau, M.D., FACNM, Ochsner Health System
  Purpose
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.

Condition Intervention Phase
Neuroendocrine Neuroendocrine Tumor Neuroendocrine Cancer Neuroendocrine Carcinoma Carcinoid Carcinoid Tumor Islet Cell Tumor Apudoma Drug: 68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography. Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 68Ga-DOTATATE PET Scan Imaging in Patients With Neuroendocrine Tumors

Resource links provided by NLM:


Further study details as provided by Richard J. Campeau, M.D., FACNM, Ochsner Health System:

Primary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Number of lesions detected by 68Ga-DOTATATE compared to conventional imaging techniques [ Time Frame: 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 ]

Estimated Enrollment: 250
Study Start Date: March 2014
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Scan
We will perform 68Ga-DOTATATE PET scans on subjects.
Drug: 68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02038738


Contacts
Contact: Richard J. Campeau, M.D. 504-464-8500

Locations
United States, Louisiana
Ochsner Medical Center - Kenner
Kenner, Louisiana, United States, 70065
Sponsors and Collaborators
Ochsner Health System
  More Information

Responsible Party: Richard J. Campeau, M.D., FACNM, Professor of Radiology and Internal Medicine, Ochsner Health System
ClinicalTrials.gov Identifier: NCT02038738     History of Changes
Other Study ID Numbers: 68Ga-DOTATATE
First Submitted: January 14, 2014
First Posted: January 17, 2014
Last Update Posted: January 17, 2014
Last Verified: January 2014

Keywords provided by Richard J. Campeau, M.D., FACNM, Ochsner Health System:
gallium
Ga
PET Scan

Additional relevant MeSH terms:
Neoplasms
Neuroendocrine Tumors
Carcinoid Tumor
Carcinoma, Neuroendocrine
Adenoma, Islet Cell
Apudoma
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Adenoma
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases