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

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 71 participants |
Allocation: | N/A |
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 |
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Experimental: 68Ga-DOTATOC PET
patients with known or suspected somatostatin receptor positive neuroendocrine tumors (NETs)
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Drug: 68Ga-DOTATOC PET
68Ga-DOTATOC as a diagnostic PET/CT imaging agent for the detection of NETs, mainly carcinoid tumors.
Other Names:
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- Change in size of lesion [ Time Frame: baseline and 1 month ]Change in size of lesion at 1 month as compared to baseline
- Incidence of new lesions [ Time Frame: baseline and 1 month ]Number of new lesions at 1 month as compared to baseline
- 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
- 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 |
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

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
United States, New York | |
Icahn School of Medicine at Mount Sinai | |
New York, New York, United States, 10029 |
Principal Investigator: | Lale Kostakoglu, MD, MPH | Icahn School of Medicine at Mount Sinai |
Responsible Party: | Lale Kostakoglu, Chief of Nuclear Medicine and Molecular Imaging, Icahn School of Medicine at Mount Sinai |
ClinicalTrials.gov Identifier: | NCT02359500 |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
68Ga- DOTATOC Diagnosis Somatostatin Receptor-Positive Neuroendocrine Tumors |
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 Octreotide Edotreotide Gastrointestinal Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Radiopharmaceuticals Molecular Mechanisms of Pharmacological Action |