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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. Identifier: NCT03001349
Recruitment Status : Terminated (Per PI Request)
First Posted : December 23, 2016
Last Update Posted : February 15, 2021
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Meningioma Metastatic Well Differentiated Neuroendocrine Neoplasm Multiple Endocrine Neoplasia Type 1 Neuroendocrine Neoplasm Somatostatin Positive Neoplastic Cells Present Von Hippel-Lindau Syndrome Procedure: Computed Tomography Drug: Gallium Ga 68-Edotreotide Procedure: Positron Emission Tomography Early Phase 1

Detailed Description:


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.


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.


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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: An Expanded Access Imaging of Neuroendocrine Tumors Using 68Ga-DOTA-TOC
Actual Study Start Date : May 16, 2017
Actual Primary Completion Date : February 5, 2021
Actual Study Completion Date : February 5, 2021

Arm Intervention/treatment
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.
Procedure: Computed Tomography
Undergo PET/CT
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • computerized tomography
  • CT
  • tomography

Drug: Gallium Ga 68-Edotreotide
Given IV
Other Names:
  • 68Ga-DOTA-d-Phe1-Tyr3-octreotide
  • 68Ga-DOTA-TOC
  • 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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03001349

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United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Homer A Macapinlac, MD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT03001349    
Other Study ID Numbers: 2016-0030
NCI-2018-01894 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2016-0030 ( Other Identifier: M D Anderson Cancer Center )
First Posted: December 23, 2016    Key Record Dates
Last Update Posted: February 15, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Endocrine Gland Neoplasms
Multiple Endocrine Neoplasia
Multiple Endocrine Neoplasia Type 1
Von Hippel-Lindau Disease
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Neurocutaneous Syndromes
Vascular Diseases
Cardiovascular Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Endocrine System Diseases
Neoplasms, Multiple Primary
Neoplastic Syndromes, Hereditary