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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ronald C. Walker MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT01396382
First received: July 11, 2011
Last updated: February 25, 2016
Last verified: February 2016
  Purpose
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 Intervention Phase
Neuroendocrine Carcinoma
Radiation: 68Ga-DOTATATE PET scan
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Use of 68Ga-DOTATATE PET Scanning for Diagnosis and Treatment of Metastatic Neuroendocrine Tumors

Resource links provided by NLM:


Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • Number of Patients That Experienced a Change in Care Plans After 68GA-DOTATATE PET Scan [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 97
Study Start Date: March 2010
Study Completion Date: December 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01396382

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

Publications:
Responsible Party: Ronald C. Walker MD, Professor of Clinical Radiology, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT01396382     History of Changes
Other Study ID Numbers: VICC GI 1136  110588 
Study First Received: July 11, 2011
Results First Received: January 14, 2016
Last Updated: February 25, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt-Ingram Cancer Center:
neuroendocrine
neuroendocrine carcinoma
neuroendocrine tumor
carcinoid
carcinoid tumor
islet cell tumor
APUDoma
Gallium
PET Scan

Additional relevant MeSH terms:
Carcinoid Tumor
Carcinoma, Neuroendocrine
Neuroendocrine Tumors
Adenocarcinoma
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuroectodermal Tumors

ClinicalTrials.gov processed this record on May 03, 2016