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

NCT01967537 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 13019313-C-0193
• Study Type: interventional
• Target: 341
• Locations: 1 country
• Sites: 1

Brief Summary

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.
• A standard computed tomography (CT) scan of the chest, abdomen, and pelvis.
• An octreotide scintigraphy Single photon emission computed tomography (SPECT)/CT.
• A 68Gallium-DOTATATE positron emission tomography (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.

Conditions

Neuroendocrine Tumors; Von Hippel-Lindau Syndrome; Hippel-Lindau Disease

Keywords

NET; MEN1; Von Hippel Lindau (VHL); Surgical Resection; Somatostatin Receptor Status

Outcome Measures

Primary Outcomes (1)

• Number of Lesions Detected Using the 68Gallium-DOTATATE Positron Emission Tomography (PET/Computed Tomography (CT)) Scan

  Patients with neuroendocrine tumors (NETs) were scanned with the 68Gallium-DOTATATE Positron Emission Tomography (PET/Computed Tomography (CT)) and the number of lesions detected are collected.

  During PET Scan, up to 2 hours annually for up to 5 years

Secondary Outcomes (5)

• Mean Radiation Activity Between Low Grade and Intermediate Grade Neuroendocrine Tumor

  During radioguided surgery, up to 2 hours

• Tumor Volume of Neuroendocrine Tumors Assessed by the 68Gallium-DOTATATE Scan

  During radioguided surgery, up to 2 hours

• Median Radioactivity of Tumors With High Expression of Somatostatin Receptor 2 Compared to Tumors With Intermediate Expression of Somatostatin Receptor 2

  During PET Scan, up to 2 hours annually

• The Number of Tumors Identified in Participants by the Radiation Detector During Radio-guided Surgery Using 68Gallium-DOTATATE

  Radio-guided surgery, up to 2 hours

• Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)

  Date treatment consent signed to date off study, approximately 50 months and 17 days.

Study Arms (1)

68Gallium DOTATATE imaging

EXPERIMENTAL

68Gallium DOTATATE imaging

Drug: 68Gallium DOTATATE; Procedure: Radio-guided surgery

Interventions

68Gallium DOTATATE DRUG

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.

68Gallium DOTATATE imaging

Radio-guided surgery PROCEDURE

Using 68Gallium DOTATATE

68Gallium DOTATATE imaging

Eligibility Criteria

• Age: 10 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with (any one of #1, #2, and/or #3):
• Suspicion of neuroendocrine tumors (NET) on axial imaging (computed tomography (CT)/magnetic resonance imaging (MRI)/fluorodeoxyglucose (FDG) positron emission tomography (PET) and/or
• 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
• familial predisposition to NET in patients with multiple endocrine neoplasia type 1 (MEN1) and Von Hippel-Lindau (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 National Institutes of Health (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.

You may not qualify if:

• 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 18F-dihydroxyphenylalanine (F-DOPA) scans, within 30 days prior to dosing.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Tsikitis VL, Wertheim BC, Guerrero MA. Trends of incidence and survival of gastrointestinal neuroendocrine tumors in the United States: a seer analysis. J Cancer. 2012;3:292-302. doi: 10.7150/jca.4502. Epub 2012 Jul 1.

  PMID: 22773933 BACKGROUND

• Lawrence B, Gustafsson BI, Chan A, Svejda B, Kidd M, Modlin IM. The epidemiology of gastroenteropancreatic neuroendocrine tumors. Endocrinol Metab Clin North Am. 2011 Mar;40(1):1-18, vii. doi: 10.1016/j.ecl.2010.12.005.

  PMID: 21349409 BACKGROUND

• Modlin IM, Lye KD, Kidd M. A 5-decade analysis of 13,715 carcinoid tumors. Cancer. 2003 Feb 15;97(4):934-59. doi: 10.1002/cncr.11105.

  PMID: 12569593 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Neuroendocrine Tumors; von Hippel-Lindau Disease

Interventions

gallium Ga 68 dotatate

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Neurocutaneous Syndromes; Nervous System Diseases; Angiomatosis; Vascular Diseases; Cardiovascular Diseases; Ciliopathies; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Results Point of Contact

• Title: Dr. Naris Nilubol
• Organization: Principal Investigator

niluboln@nih.gov

301-451-2355

Study Officials

• Naris Nilubol, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: October 23, 2013
• Study Start: October 18, 2013
• Primary Completion: December 17, 2017
• Study Completion: March 12, 2018
• Last Updated: November 19, 2019
• Results First Posted: April 2, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)