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

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Brief Title

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

Official Title

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 Phase

Early Phase 1

Study Type

Interventional


Primary Outcome

Incidence of adverse events


Condition

Meningioma

Intervention

Computed Tomography

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

4

Start Date

May 16, 2017

Completion Date

February 5, 2021

Primary Completion Date

February 5, 2021

Eligibility Criteria

        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
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Homer A Macapinlac, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03001349

Organization ID

2016-0030

Secondary IDs

NCI-2018-01894

Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Homer A Macapinlac, MD, Principal Investigator, M.D. Anderson Cancer Center


Verification Date

February 2021