68Ga-DOTA-TOC PET/CT in Imaging Participants With Neuroendocrine Tumors

NCT03001349 | Terminated Early Phase 1 FDA Drug

• 2 other identifiers: 2016-0030NCI-2018-01894
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This trial studies how well gallium Ga 68-edotreotide (68Ga-DOTA-TOC) positron emission tomography (PET)/computer tomography (CT) works in imaging participants with neuroendocrine tumors. 68Ga-DOTA-TOC is used as a tracer chemical during PET/CT scans. Diagnostic procedures, such as 68Ga-DOTA-TOC PET/CT, may help find and diagnose neuroendocrine tumors.

Conditions

Meningioma; Metastatic Well Differentiated Neuroendocrine Neoplasm; Multiple Endocrine Neoplasia Type 1; Neuroendocrine Neoplasm; Somatostatin Positive Neoplastic Cells Present; Von Hippel-Lindau Syndrome

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  As measured by National Cancer Institute Common Terminology Criteria for Adverse Events version 4. Traceable toxicity/safety data will be assessed. Adverse events and vital signs will be monitored and described with descriptive statistics.

  Up to 30 days

Study Arms (1)

Diagnostic (gallium Ga 68-edotreotide, PET/CT)

EXPERIMENTAL

Participants receive gallium Ga 68-edotreotide intravenously. After 1 hour, participants undergo PET/CT scan over 60 minutes.

Procedure: Computed Tomography; Drug: Gallium Ga 68-Edotreotide; Procedure: Positron Emission Tomography

Interventions

Computed Tomography PROCEDURE

Undergo PET/CT

Also known as: CAT, CAT Scan, Computerized Axial Tomography, computerized tomography, CT, CT SCAN, tomography

Diagnostic (gallium Ga 68-edotreotide, PET/CT)

Gallium Ga 68-Edotreotide DRUG

Given IV

Also known as: 68Ga-DOTA-d-Phe1-Tyr3-octreotide, 68Ga-DOTA-TOC, EDOTREOTIDE GALLIUM GA-68, Ga-68 DOTA0-Tyr3-octreotide, Ga-68 DOTATOC, Ga-68-DOTA-TOC, Ga-68-DOTA-Tyr(3)-octreotide, Gallium Ga 68-DOTATOC

Diagnostic (gallium Ga 68-edotreotide, PET/CT)

Positron Emission Tomography PROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Diagnostic (gallium Ga 68-edotreotide, PET/CT)

Eligibility Criteria

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

You may qualify if:

• Ability of the subject, or the 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
• All participants must meet one of the following:
• Patients diagnosed or suspected to have neuroendocrine tumors (NET), who require 111In-pentetreotide imaging for clinical indications
• Subjects with a high risk of NET because of familial predisposition, and also have clinical findings which require radiolabeled somatostatin imaging
• Other somatostatin-positive tumors for which 111In-pentetreotide has been used successfully, such as adult meningiomas
• Patients with suspected neuroendocrine tumor, unknown primary NET, metastatic NET, or other tumors, such as meningiomas, in whom the primary physician considers somatostatin imaging to be clinically indicated
• Other NET subjects, whether asymptomatic or symptomatic, sporadic or familial, such as Von Hippel-Lindau syndrome (VHL) and multiple endocrine neoplasia type 1 (MEN1), will also be included

You may not qualify if:

• Lactating women are excluded if patient is unwilling to suspend lactation for at least one day following the administration of 68Ga-DOTATOC to the mother, because of the unknown but potential risk for adverse events in nursing infants secondary to administration of the radionuclide to a lactating woman
• Subjects with known contraindications to the use of 111In-pentetreotide
• Known severe allergy or hypersensitivity to oral contrast precludes administration of oral contrast only
• Patients with a body weight of 400 pounds or more, or a body mass index (BMI) which precludes their entry into the bore of the PET/CT scanner, because of the resulting probable compromise in image quality with CT, PET/CT and magnetic resonance imaging (MRI)
• Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator may significantly interfere with study compliance

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Meningioma; Multiple Endocrine Neoplasia Type 1; Neuroendocrine Tumors; von Hippel-Lindau Disease

Interventions

gallium Ga 68 dotatate; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neurocutaneous Syndromes; Angiomatosis; Vascular Diseases; Cardiovascular Diseases; Ciliopathies; Abnormalities, Multiple; Congenital Abnormalities

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Homer A Macapinlac, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: December 23, 2016
• Study Start: May 16, 2017
• Primary Completion: February 5, 2021
• Study Completion: February 5, 2021
• Last Updated: February 15, 2021

Record last verified: 2021-02

Locations

US (1)