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68Ga-DOTATATE PET Scan in Neuroendocrine Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eric H Liu, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01396382
First received: July 11, 2011
Last updated: December 16, 2013
Last verified: December 2013
  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
Drug: 68Ga-DOTATATE PET scan
Phase 1
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: 68Ga-DOTATATE PET Scanning for Diagnosis and Treatment of Neuroendocrine Tumors

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    Determine if any adverse effects are associated with the scan and the number of patients that experience them.


Secondary Outcome Measures:
  • Number of lesions detected by 68GA-DOTATATE compared to conventional imaging techniques [ Time Frame: one year ] [ Designated as safety issue: No ]
    We want to determine if the 68Ga-DOTATATE PET scan changes care plans compared to conventional imaging/diagnostic techniques (Octreoscan, MRI, CT, U/S).


Enrollment: 99
Study Start Date: August 2011
Estimated Study Completion Date: March 2014
Primary Completion Date: October 2013 (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 PET scan
68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.

  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 University
  More Information

No publications provided

Responsible Party: Eric H Liu, Assistant Professor, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01396382     History of Changes
Other Study ID Numbers: 110588
Study First Received: July 11, 2011
Last Updated: December 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Vanderbilt University:
neuroendocrine
neuroendocrine carcinoma
neuroendocrine tumor
carcinoid
carcinoid tumor
islet cell tumor
APUDoma
Gallium
PET Scan

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Neuroendocrine
Neuroendocrine Tumors
Adenocarcinoma
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 November 27, 2014