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68Ga-DOTATATE PET Scan in Neuroendocrine Cancer (68Ga)

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. Read our disclaimer for details. Identifier: NCT01396382
Recruitment Status : Completed
First Posted : July 18, 2011
Results First Posted : March 29, 2016
Last Update Posted : March 29, 2016
Information provided by (Responsible Party):
Ronald C. Walker MD, Vanderbilt-Ingram Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Neuroendocrine Carcinoma Radiation: 68Ga-DOTATATE PET scan Phase 2

Detailed Description:
Eligible participants will undergo baseline assessments at enrollment. Study participants will receive a one-time administration of 68GaDOTATATE and undergo a PET/CT imaging study. Scans will be performed with "negative" oral contrast (e.g. Volumen™ or equivalent), as many NETs involve the GI tract.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Use of 68Ga-DOTATATE PET Scanning for Diagnosis and Treatment of Metastatic Neuroendocrine Tumors
Study Start Date : March 2010
Actual Primary Completion Date : May 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: 68Ga-DOTATATE PET
Patients will receive a 68Ga-DOTATATE PET scans
Radiation: 68Ga-DOTATATE PET scan
68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography (PET). Efficacy of the 68Ga-DOTATATE PET scan was assessed and compared to 111In-Pentetreotide scan and to scans with CT and/or MRI. Safety and toxicity were also assessed with pre-injection and post-imaging vital signs, pulse oximetry on room air, 12 lead ECGs, and blood laboratory tests, including tumor markers, liver and renal functions and blood counts, and direct patient questioning. Late delayed tumor markers, liver and renal functions and blood counts were assessed when available.

Primary Outcome Measures :
  1. Number of Patients That Experienced a Change in Care Plans After 68GA-DOTATATE PET Scan [ Time Frame: at 1 year ]
    Determine if the 68Ga-DOTATATE PET scan changes patient care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI, CT, U/S).

Secondary Outcome Measures :
  1. Number of Severe Adverse Events Occurences Resulting in Changes to Patient Treatment Plans, as a Measure of Safety and Tolerability [ Time Frame: at 1 year ]
    Determine if any adverse effects are associated with the 68Ga-DOTATATE PET scan and the number of patients that experience them using NCI Common Terminology Criteria for Adverse Events v4.0, where: Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life‐threatening; Grade 5, death. Toxicities present at baseline and continuing without change in grade were excluded for assessment of this outcome measure.

Information from the National Library of Medicine

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

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.

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 identifier (NCT number): NCT01396382

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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
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Principal Investigator: Ronald C. Walker, MD Vanderbilt-Ingram Cancer Center

Publications of Results:
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Responsible Party: Ronald C. Walker MD, Professor of Clinical Radiology, Vanderbilt-Ingram Cancer Center Identifier: NCT01396382     History of Changes
Other Study ID Numbers: VICC GI 1136
110588 ( Other Identifier: Vanderbilt University Medical Center, Radiology Dept )
First Posted: July 18, 2011    Key Record Dates
Results First Posted: March 29, 2016
Last Update Posted: March 29, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data are primarily imaging data and toxicity data submitted for peer-review publication and US FDA review, but not shared with a public data archive.
Keywords provided by Ronald C. Walker MD, Vanderbilt-Ingram Cancer Center:
neuroendocrine carcinoma
neuroendocrine tumor
carcinoid tumor
islet cell tumor
PET Scan
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Carcinoma, Neuroendocrine
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue