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Trial record 46 of 2710 for:    Neoplasms, Germ Cell and Embryonal | Neuroendocrine Tumors

68Ga-DOTATOC for Imaging of Neuroendocrine Tumors: Expanded Access Trial

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ClinicalTrials.gov Identifier: NCT02358018
Expanded Access Status : No longer available
First Posted : February 6, 2015
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
The purpose of this study is to use a new type of scan, called 68Ga-DOTATOC PET/CT scan, instead of OctreoScan, the standard scan, to diagnose, monitor and manage your tumor. 68Ga-DOTATOC is an improved imaging agent being routinely used in many centers outside the USA, with better tumor detection than with OctreoScan.

Condition or disease Intervention/treatment
Neuroendocrine Tumors Drug: 68Ga-DOTATOC PET/CT Scan

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Study Type : Expanded Access
Official Title: 68Ga-DOTATOC for Imaging of Neuroendocrine Tumors: Expanded Access Trial



Intervention Details:
  • Drug: 68Ga-DOTATOC PET/CT Scan
    Study participants will undergo the 68Ga-DOTATOC PET/CT after informed consent. The nominal injected dose will be up 3-5.5 mCi containing approximately 10 - 50 microgram of 68Ga-DOTATOC and will be injected via IV access lines. CT scans will be performed with our standard oral contrast agent (typically Omnipaque and/or barium) in accordance with our standard FDG practice unless some contraindication is present. Uptake period following injection will be 0.75-1hour. Acquisition time will be approximately ~1 hour. In patients who may not be able to lie still, anesthesia will be provided as per routine standard clinical practice.

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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • Patients diagnosed or suspected NET requiring 111In-pentetreotide imaging for clinical indications.
  • High risk of NET because of familial predisposition with clinical findings requiring radiolabeled somatostatin imaging.
  • Other somatostatin positive tumor for which 111In-pentetreotide has been used successfully (for example adult meningioma).
  • 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.

Exclusion Criteria:

  • Pregnant or lactating women: Pregnant women are excluded from this study because the effects of 68Ga-DOTATOC in pregnancy are not known; exceptions may be performed if expected risk outweighs the benefit. Pregnancy testing will follow MITS procedure for diagnostic reagents. Patients self report pregnancy status. If pregnant the test will not be performed unless in the clinical opinion of the attending physician the gain of the test is likely to outweigh the risk (this will be rare). If unsure whether pregnant or not then a urine or serum pregnancy will be performed.
  • Because there is an unknown but potential risk for adverse events in nursing infants secondary to administration of 68Ga-DOTATOC in the mother, breastfeeding should be discontinued for at least one day if the mother receives 68Ga-DOTATOC.
  • Patients that have contraindications for 111In-pentetreotide.
  • Known severe allergy or hypersensitivity to oral contrast will preclude administration of such contrast (will preclude receiving oral contrast only).
  • Patients with a body weight of 400 pounds or more or not able to enter the bore of the PET/CT scanner due to BMI, because of the compromise in image quality with CT, PET/CT and MRI that will result.
  • 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 ClinicalTrials.gov identifier (NCT number): NCT02358018


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Ravinder Grewal, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02358018     History of Changes
Other Study ID Numbers: 14-226
First Posted: February 6, 2015    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Keywords provided by Memorial Sloan Kettering Cancer Center:
68Ga-DOTATOC
PET/CT scan
14-226

Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Edotreotide
Octreotide
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents