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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03001349
Recruitment Status : Active, not recruiting
First Posted : December 23, 2016
Last Update Posted : December 5, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date  ICMJE December 20, 2016
First Posted Date  ICMJE December 23, 2016
Last Update Posted Date December 5, 2019
Actual Study Start Date  ICMJE May 16, 2017
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2019)
Incidence of adverse events [ Time Frame: Up to 30 days ]
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 68Ga-DOTA-TOC PET/CT in Imaging Participants With Neuroendocrine Tumors
Official Title  ICMJE An Expanded Access Imaging of Neuroendocrine Tumors Using 68Ga-DOTA-TOC
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.
Detailed Description

PRIMARY OBJECTIVES:

I. To substitute 68Ga-DOTATOC for 111In-pentetreotide on an expanded access basis, in tumor imaging for study subjects, where the care provider believes that somatostatin imaging is clinically indicated, until such time as 68Ga-DOTATOC becomes commercially available.

SECONDARY OBJECTIVES:

I. To gain experience in the utility of 68Ga-DOTATOC in the management of neuroendocrine tumors at The University of Texas M.D. Anderson Cancer Center (MDACC).

II. To acquire proficiency in generating 68Ga-DOTATOC for human use at MDACC.

OUTLINE:

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

After completion of study, participants are followed up at 24 hours or within 72 hours, and at 30 days.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Meningioma
  • Metastatic Well Differentiated Neuroendocrine Neoplasm
  • Multiple Endocrine Neoplasia Type 1
  • Neuroendocrine Neoplasm
  • Somatostatin Positive Neoplastic Cells Present
  • Von Hippel-Lindau Syndrome
Intervention  ICMJE
  • Procedure: Computed Tomography
    Undergo PET/CT
    Other Names:
    • CAT
    • CAT Scan
    • Computerized Axial Tomography
    • computerized tomography
    • CT
    • CT SCAN
    • tomography
  • Drug: Gallium Ga 68-Edotreotide
    Given IV
    Other Names:
    • 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
  • Procedure: Positron Emission Tomography
    Undergo PET/CT
    Other Names:
    • Medical Imaging, Positron Emission Tomography
    • PET
    • PET Scan
    • Positron Emission Tomography Scan
    • Positron-Emission Tomography
    • proton magnetic resonance spectroscopic imaging
Study Arms  ICMJE Experimental: Diagnostic (gallium Ga 68-edotreotide, PET/CT)
Participants receive gallium Ga 68-edotreotide intravenously. After 1 hour, participants undergo PET/CT scan over 60 minutes.
Interventions:
  • Procedure: Computed Tomography
  • Drug: Gallium Ga 68-Edotreotide
  • Procedure: Positron Emission Tomography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 20, 2018)
100
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Pregnant women are excluded from this study because the effects of 68Ga-DOTATOC in pregnancy are not known; exceptions may be granted only if the expected risk outweighs the benefit, in the clinical opinion of the attending physician. Pregnancy testing will follow MD Anderson procedure for diagnostic reagents. Self-reporting is used to assess pregnancy status. If the subject is unsure about her status, a urine or serum pregnancy test will be performed before inclusion
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03001349
Other Study ID Numbers  ICMJE 2016-0030
NCI-2018-01894 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2016-0030 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor  ICMJE M.D. Anderson Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Elmer Santos M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date December 2019

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