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

This study is currently recruiting participants.
Verified October 16, 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 10, 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) )
October 18, 2013
October 23, 2013
November 10, 2017
October 18, 2013
January 1, 2021   (Final data collection date for primary outcome measure)
To assess the diagnostic accuracy of the new imaging technique (68)Gallium-DOTATATE PET/CT scan for patients with NETs [ Time Frame: 3 years ]
Same as current
Complete list of historical versions of study NCT01967537 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
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Evaluation of 68Gallium-DOTATATE PET/CT for Detecting Neuroendocrine Tumors
Evaluation of (68)Gallium- DOTATATE PET/CT for Detecting Primary and Metastatic Neuroendocrine Tumors

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.

Background:

  • Neuroendocrine tumors (NETs) are rare malignancies occurring in the gastrointestinal tract, islets of the pancreas, lung, adrenal medulla and thyroid C-cells.
  • Their incidence has increased over the last decade, with an incidence of 6 per 100,000 persons a year and they represent 0.46% of all malignancies.
  • Most NETs are sporadic, but they can be part of familial cancer syndromes such as multiple endocrine neoplasia type 1 (MEN1), MEN2, and neurofibromatosis type 1 (NF1) or Von Hippel-Lindau (VHL) syndrome.
  • Surgical resection remains the only curative treatment option for patients with NETs but 80% of patients are diagnosed with advanced (metastatic, locally inoperable, or recurrent) disease.
  • The main prognostic factor in patients with NET is the extent of disease.
  • The best imaging technique for detecting unknown primary and metastatic NETs has yet to be determined.
  • NET cells express somatostatin receptors that can be targeted with radiolabeled 68Gallium-DOTATATE (Octreotate) for imaging purposes.
  • The primary goal of this protocol is to determine the accuracy of a new somatostatin receptor targeted imaging technique, using 68Gallium-DOTATATE PET/CT to detect unknown primary and metastatic NETs.

Objectives:

-To determine the accuracy of 68Gallium-DOTATATE PET/CT scans in detecting unknown primary and metastatic gastrointestinal and pancreatic neuroendocrine tumors.

Eligibility:

  • Patients with:

    • suspicion of NET on axial imaging (CT/MRI/FDG PET) and/or
    • biochemical evidence of NET (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
    • familial predisposition to NET in patients with MEN1 and VHL.
  • Age greater than or equal to 18 years of age.
  • Patients must be willing to return to NIH for follow-up.

Design:

  • Prospective study.
  • A 68Ga-DOTATATE PET/CT scan will be done in patients with suspicious lesions, unknown primary tumor or metastatic gastrointestinal or pancreatic neuroendocrine disease found on anatomic imaging (CT/MRI) or in patients having biochemically active disease.
  • Both functional and non-functional solid tumors will be included in this study. Furthermore, asymptomatic and symptomatic, sporadic and familial cases of NETs (such as VHL, MEN1) will be included.
  • Demographic, clinical and pathologic data will be collected from the medical record and patient interview for each patient. Data will be stored in a computerized database.
  • After their initial on-study evaluation, patients will be staged according to findings on imaging studies with respect to primary tumor site, size and metastases. Surgical resection of NET and/or medical managements will be recommended based on standard practice guidelines. In patients who undergo surgical treatment, the samples will be immediately stored until molecular analysis.
  • Follow up will be done yearly for a total duration of 5 years. This includes a yearly imaging study and a biochemical and clinical evaluation, to assess tumor growth and disease progression.
  • We estimate that the accrual rate will be 3-10 patients per month; the total accrual period for this study will be 10 months to 3 years.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Neuroendocrine Tumors
  • Von Hippel-Lindau Syndrome
  • Hippel-Lindau Disease
  • 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
Experimental: A
68Gallium DOTATATE imaging
Interventions:
  • Drug: 68Gallium DOTATATE
  • Procedure: Radio-guided surgery

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
390
December 3, 2022
January 1, 2021   (Final data collection date for primary outcome measure)
  • 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.
Sexes Eligible for Study: All
10 Years to 99 Years   (Child, Adult, Senior)
No
Contact: Roxanne E Merkel (301) 402-4395 ncieobinquiry@mail.nih.gov
Contact: Electron Kebebew, M.D. (240) 760-6153 kebebewe@mail.nih.gov
United States
 
 
NCT01967537
130193
13-C-0193
Not Provided
Not Provided
Not Provided
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Electron Kebebew, M.D. National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC)
October 16, 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP