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Evaluation of 68Gallium-DOTATATE PET/CT for Detecting Neuroendocrine Tumors

This study is currently recruiting participants.
Verified November 8, 2017 by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT01967537
First Posted: October 23, 2013
Last Update Posted: November 20, 2017
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):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
  Purpose

Background:

- Neuroendocrine tumors (NETs) are rare but have been more common over the past decade. The only treatment for NETs is surgery, but most are found when they are too advanced for surgery. Researchers are looking for the best way to find NETs earlier, so that surgery can be successful. They want to test if the study drug can be used along with imaging devices to detect NETs.

Objectives:

- To see how well a new experimental imaging agent, 68Gallium-DOTATATE, detects unknown primary and metastatic NETs in the gastrointestinal system and pancreas.

Eligibility:

- Adults over 10 years old with a suspected NET or family history of NET.

Design:

  • Participants will be screened with a medical history and physical exam, and have a blood test.
  • Participants will undergo three scans. For all of these, a substance is injected into their body, they lie on a table, and a machine takes images.

<TAB>- A standard CT scan of the chest, abdomen, and pelvis.

<TAB>- An octreotide scintigraphy SPECT/CT.

<TAB>- A 68Gallium-DOTATATE PET/CT. The study drug is injected into a vein, usually in the arm. Low-dose X-rays go through the body. For about 40 minutes a large, donut-shaped device takes images of the body. The entire session takes 90 to 120 minutes.

  • Researchers will compare images from the three scans.
  • Participants will have 1 follow-up visit each year for 5 years. At this visit, they will have a medical exam, blood taken, and a CT scan.

Condition Intervention Phase
Neuroendocrine Tumors Von Hippel-Lindau Syndrome Hippel-Lindau Disease Drug: 68Gallium DOTATATE Procedure: Radio-guided surgery Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of (68)Gallium- DOTATATE PET/CT for Detecting Primary and Metastatic Neuroendocrine Tumors

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):

Primary Outcome Measures:
  • To assess the diagnostic accuracy of the new imaging technique (68)Gallium-DOTATATE PET/CT scan for patients with NETs [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • Correlation between 68Gallium- DOTATATE uptake in NETs andtumor differentiation [ Time Frame: Five years ]
  • Correlation between 68Gallium- DOTATATE uptake and tumorgrowth and/or disease progression [ Time Frame: Five years ]
  • Correlation between somatostatin receptor status in tumor samplesand 68Gallium-DOTATATE uptake [ Time Frame: Five years ]
  • Feasibility of radio-guided surgery in NETs using 68Gallium-DOTATATE [ Time Frame: Five years ]

Estimated Enrollment: 390
Study Start Date: October 18, 2013
Estimated Study Completion Date: December 3, 2022
Estimated Primary Completion Date: January 1, 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
68Gallium DOTATATE imaging
Drug: 68Gallium DOTATATE
Fasting is not required prior to the imaging study. An IV line with a large bore (21 gauge or more) will be placed preferably in the antecubital vein, and, with the patient supine, around 5mCi of the 68Ga-DOTATATE will be administered intravenously, followed by incubation for approximately 60 minutes. Then the patient will be positioned in a PET/CT scanner and images from the upper thighs to the base of the skull will be obtained. In patients with tumor induced osteomalacia, images from the top of the head to the toes will be obtained.
Procedure: Radio-guided surgery
Using 68Gallium DOTATATE

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 99 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • Patients with (any one of #1, #2, and/or #3):

    1. Suspicion of NET on axial imaging (CT/MRI/FDG PET) and/or
    2. biochemical evidence of neuroendocrine tumor (serum/urinary) based on elevated levels of chromogranin A, pancreatic polypeptide, neuron-specific enolase, vasoactive intestinal polypeptide, serotonin (urinary 5-HIAA), gastrin, somatostatin, catecholamines, metanephrines, calcitonin, fasting insulin, C-peptide (proinsulin), glucagon and/or
    3. familial predisposition to NET in patients with MEN1 and VHL (symptomatic and/or asymptomatic cases; with biochemical or anatomic imaging evidence of disease).
  • Age greater than or equal to 10 years of age.
  • For females: Negative urine pregnancy test OR post-menopausal for at least 2 years OR patient has had a hysterectomy.
  • Patients must be willing to return to NIH for follow-up.
  • Ability of subject or Legally Authorized Representative (LAR) (if the patient is deemed by the treating physician to be cognitively impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable) to understand and the willingness to sign a written informed consent document indicating that they are aware of the investigational nature of this study.

EXCLUSION CRITERIA:

  • Patients unwilling to undergo serial non-invasive imaging.
  • Pregnant or lactating women: Pregnant women are excluded from this study because the effects of (68)Ga-DOTATATE in pregnancy are not known. Because there is an unknown but potential risk for adverse events in nursing infants secondary to administration of

    (68)Ga-DOTATATE in the mother, breastfeeding should be discontinued for at least one day if the mother receives (68)Ga-DOTATATE.

  • Patients that have recognized concurrent active infection,
  • Patients with the use of any investigational product or device, excluding F-DOPA scans, within 30 days prior to dosing.
  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): NCT01967537


Contacts
Contact: Roxanne E Merkel (301) 402-4395 ncieobinquiry@mail.nih.gov
Contact: Electron Kebebew, M.D. (240) 760-6153 kebebewe@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Electron Kebebew, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01967537     History of Changes
Other Study ID Numbers: 130193
13-C-0193
First Submitted: October 18, 2013
First Posted: October 23, 2013
Last Update Posted: November 20, 2017
Last Verified: November 8, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
NET
MEN1
Von Hippel Lindau (VHL)
Surgical Resection
Somatostatin Receptor Status

Additional relevant MeSH terms:
Von Hippel-Lindau Disease
Neuroendocrine Tumors
Carcinoid Tumor
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neurocutaneous Syndromes
Nervous System Diseases
Angiomatosis
Vascular Diseases
Cardiovascular Diseases