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Trial record 28 of 2728 for:    tumor | Neuroendocrine Tumors

68Ga-Dotatoc Positron Emission Tomography (PET) for Somatostatin Receptor-Positive Neuroendocrine Tumors (NETs)

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ClinicalTrials.gov Identifier: NCT02359500
Recruitment Status : Terminated (compound no longer available)
First Posted : February 10, 2015
Last Update Posted : May 3, 2017
Sponsor:
Information provided by (Responsible Party):
Lale Kostakoglu, Icahn School of Medicine at Mount Sinai

Brief Summary:
This study plans to demonstrate the safety and efficacy of [68Ga]-DOTA-tyr3-Octreotide ([68Ga]-DOTATOC) as an accurate imaging technique for diagnosis, staging, and monitoring of response to treatment in patients with Somatostatin receptor expressing tumors who undergo imaging with a clinical indication. The investigators will conduct a study for 68Ga-DOTATOC as a diagnostic PET/CT imaging agent for the detection of NETs, mainly carcinoid tumors. 68Ga-DOTATOC will be used in diagnostic assessment of patients with known or suspected NETs for whom there is an appropriate standard clinical indication for 68Ga-DOTATOC PET/CT either at staging or during follow up.

Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Carcinoid Tumors Drug: 68Ga-DOTATOC PET Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Safety and Efficacy Study of 68Ga-Dotatoc Positron Emission Tomography for Diagnosis for Staging, Restaging and Assessment of Response to Treatment in Somatostatin Receptor-Positive Neuroendocrine Tumors
Actual Study Start Date : December 2014
Actual Primary Completion Date : January 23, 2017
Actual Study Completion Date : January 23, 2017


Arm Intervention/treatment
Experimental: 68Ga-DOTATOC PET
patients with known or suspected somatostatin receptor positive neuroendocrine tumors (NETs)
Drug: 68Ga-DOTATOC PET
68Ga-DOTATOC as a diagnostic PET/CT imaging agent for the detection of NETs, mainly carcinoid tumors.
Other Names:
  • [68Ga]-DOTA-tyr3-Octreotide
  • [68Ga]-DOTATOC




Primary Outcome Measures :
  1. Change in size of lesion [ Time Frame: baseline and 1 month ]
    Change in size of lesion at 1 month as compared to baseline


Secondary Outcome Measures :
  1. Incidence of new lesions [ Time Frame: baseline and 1 month ]
    Number of new lesions at 1 month as compared to baseline

  2. Incidence of change in treatment [ Time Frame: baseline and 1 month ]
    Change in treatment caused by result of 68Ga-DOTATOC PET/CT at 1 month as compared to baseline

  3. Incidence of previously unknown primary tumor [ Time Frame: baseline and 1 month ]
    Incidence of identification of the location of a previously unknown primary tumor at 1 month as compared to baseline



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Known or suspected somatostatin receptor positive NETs (e.g. carcinoid, pancreatic neuroendocrine tumors, and pheochromocytoma). Supporting evidence may include MRI, CT, biochemical markers, and or pathology report.
  • Karnofsky performance status of ≥50 (or ECOG/WHO equivalent)
  • Off Sandostatin (octreotide acetate)-long acting release (LAR) > 4 weeks and off immediate release (subcutaneous) for at least 12 hrs prior to 68Ga-DOTATOC PET-CT imaging
  • Able to provide informed consent
  • At least 18 years of age

Exclusion Criteria:

  • Pregnancy or breast feeding. A negative serum pregnancy test is required for all female subjects with child- bearing potential
  • Surgical resection, chemotherapy, radiation therapy, or biologic therapy since last Octreoscan + CT; continuation of the same dose of Sandostatin-LAR or subcutaneous Sandostatin is allowed
  • Medical condition uncontrolled by treatment making completion of study unlikely
  • Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET/CT scanner due to Body Mass Index (BMI)
  • Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (e.g. severe claustrophobia)
  • Any additional medical condition, serious intercurrent illness or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study performance or interpretation

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): NCT02359500


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Lale Kostakoglu
Investigators
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Principal Investigator: Lale Kostakoglu, MD, MPH Icahn School of Medicine at Mount Sinai

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Responsible Party: Lale Kostakoglu, Chief of Nuclear Medicine and Molecular Imaging, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02359500     History of Changes
Other Study ID Numbers: GCO 14-2008
First Posted: February 10, 2015    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lale Kostakoglu, Icahn School of Medicine at Mount Sinai:
68Ga- DOTATOC
Diagnosis
Somatostatin Receptor-Positive Neuroendocrine Tumors

Additional relevant MeSH terms:
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Neoplasms
Neuroendocrine Tumors
Carcinoid Tumor
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Neoplasms, Glandular and Epithelial
Adenocarcinoma
Carcinoma
Somatostatin
Edotreotide
Octreotide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents