Trial record 7 of 25 for:    "von hippel-lindau syndrome"

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

This study is currently recruiting participants.
Verified August 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT01967537
First received: October 18, 2013
Last updated: March 14, 2014
Last verified: August 2013
  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 18 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
Drug: 111 In- Octreotide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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):

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: 68Gallium DOTATATE
    N/A
    Drug: 111 In- Octreotide
    N/A
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 or FGF23 in patients with tumor- induced osteomalacia 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 18 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 return to the NIH for follow-up.
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01967537

Contacts
Contact: Candice M Cottle-Delisle, R.N. (301) 402-4395 cottlec@mail.nih.gov
Contact: Electron Kebebew, M.D. (301) 496-5049 kebebewe@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: Kaitlyn Chambers    301-402-4395    kaitlyn.chambers@nih.gov   
Contact: Roxanne Merkel    (301) 402-4395    merkelre@mail.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Electron Kebebew, M.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier: NCT01967537     History of Changes
Other Study ID Numbers: 130193, 13-C-0193
Study First Received: October 18, 2013
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Von Hippel-Lindau Disease
Neuroendocrine Tumors
Neurocutaneous Syndromes
Nervous System Diseases
Angiomatosis
Vascular Diseases
Cardiovascular Diseases
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Octreotide
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 17, 2014